Subjects on bisphosphonates for any cancer or on hormone therapy for prostate cancer may continue this therapy. However, subjects with prostate cancer must have confirmed metastatic disease that has progressed despite hormonal therapy producing castrate levels of testosterone.
Treatment with any of the following for prostate cancer within 4 weeks prior to day 1 of treatment:
Saw palmetto or other therapies thought to have endocrine effects on prostate cancer
Prostate cancer patients must have received and progressed on enzalutamide
Evidence of prostate cancer progression by any of the following criteria: radiographic or PSA criteria, or symptomatic progression related to prostate cancer
Histologic confirmation of original prostate cancer diagnosis per institutional standard; life expectancy of greater than 6 months
Solid tumors measurable according to RECIST 1.1 or solid tumors not measurable according to RECIST 1.1, but which express tumor markers (e.g., prostate cancer with prostate specific antigen (PSA) expression or ovarian cancer with cancer antigen-125 (CA-125) expression) are eligible.
Prior systemic chemotherapy for prostate cancer.
Prior use of ketoconazole for the purposes of prostate cancer therapy
Prior chemotherapy for prostate cancer (upfront, adjuvant, etc.) is allowed as long as it was not given for hormone-refractory disease
Asymptomatic or mildly symptomatic form of prostate cancer
Confirmation of adenocarcinoma of the prostate that is documented by one of the following: pathology report or clinic note with documented history of prostate cancer
Prostatic intraepithelial neoplasia without evidence of prostate cancer
Prostate cancer is diagnosed by MR image guided biopsies
History of prior treatment for prostate cancer.
Low-grade prostate cancer
Decision to manage prostate cancer with active surveillance
Prior systemic chemotherapy for prostate cancer.
Prior systemic chemotherapy for prostate cancer
Prior ADT with GnRH analogue for prostate cancer for more than 2 weeks
Asymptomatic or mildly symptomatic form prostate cancer; no use of regularly scheduled opiate analgesics for prostate cancer-related pain; (patients with a malignancy other than prostate cancer are excluded from this criterion)
No previous local therapy for prostate cancer
Prostate deemed resectable by surgeon
Previous local therapy for prostate cancer
Previous chemotherapy for prostate cancer
Prior radiation therapy to the prostate or lower pelvis encompassing the prostate
Radically treated prostate cancer (prostatectomy or radiotherapy) with normal prostate-specific antigen, and not requiring ongoing antiandrogen hormonal therapy.
Measurable disease, with the exception of prostate cancer
If had prior definitive radiation therapy to the prostate: no evidence of locally persistent or recurrent prostate cancer on digital rectal exam (DRE) and imaging studies (CT or MRI)
Prior radiation to the prostate
Histologic diagnosis of prostate cancer identifying Gleason score of 3+4 on one half of the prostate gland in no more than 2 sextants of the prostate gland and not present in more than 50% of any one core taken systematically. The involvement criterion does not apply to cores taken from MRI suspicious volumes.
Prostate cancer stage up to cT2a - N0/Nx - M0/Mx.
Prostate volume ?25 mL and ?70 mL.
Subjects receiving any treatment other than AS for prostate cancer.
Patients who have had any prior chemotherapy or radiotherapy for prostate cancer.
Patients with known metastatic prostate cancer.
Any prior treatment for castration-resistant prostate cancer (CRPC) with carboplatin, cisplatin, cabazitaxel or olaparib.
Subjects must have measurable disease (RECIST v 1.1) or patients may have bone metastatic disease evaluable by Prostate Cancer Working Group 2 (PCWG2) for subjects with metastatic castration-resistant prostate cancer (CRPC) or according to tumor evaluation criteria best suitable and accepted for the tumor type evaluated.
Patients with a current diagnosis of prostate cancer will be excluded
Patients with high-risk prostate cancer (at least 1 core with Gleason sum >= 8) must have at least three core biopsies involved with cancer (a minimum of 6 core biopsies, must be obtained at baseline). A prostate biopsy within 3 months from screening is allowed for entry requirements.
Ongoing hormonal therapy administered for control of cancer (e.g., breast cancer, prostate cancer), which may be continued throughout the study
Prostate size ? 50 cc
Asymptomatic or mildly symptomatic from prostate cancer
No treatment with any of the following for prostate cancer within 4 weeks prior to enrollment:
No prior chemotherapy for prostate cancer
Prior immunotherapy or chemotherapy for prostate cancer
Histologically confirmed diagnosis of prostate cancer; histologic variants of prostate cancer, including neuroendocrine features and small cell carcinoma of the prostate are included; if neuroendocrine prostate cancer is not biopsy proven, clinical evidence of neuroendocrine prostate cancer is acceptable for stratification into group A
Prostatic intraepithelial neoplasia without evidence of prostate cancer.
Metastatic prostate cancer
Prior immunotherapy/vaccine therapy for prostate cancer
Patients who have had prior chemotherapy for prostate cancer
Very low risk and low risk groups will be confirmed by Oncotype DX prostate cancer test and provided a genomic prostate score (GPS)
Prior history of treated prostate cancer
Prostate volume greater than 80 cc on transrectal ultrasound
Participation in other clinical trials of investigational agents for the treatment of prostate cancer or other diseases.
Asymptomatic or minimally symptomatic (not requiring opioids for cancer related pain) metastatic castration-resistant prostate cancer (CRPC) patients on abiraterone as standard of care and achieved at least 50% decline of their pre-treatment PSA
Prior cabazitaxel or radium 233 for prostate cancer
Previously treated with ketoconazole for prostate cancer for greater than 7 days
Documented evidence of metastatic castration resistant prostate cancer (mCRPC).
Prior radiotherapy, surgery, chemotherapy, or hormonal therapy for prostate cancer
Prior systemic chemotherapy for prostate cancer
Any patient with clinically localized, histologically proven adenocarcinoma of prostate who has not received any treatment for prostate cancer ever and has chosen active surveillance; treatment for prostate cancer is defined as prostatectomy, androgen deprivation, brachytherapy or a full course of external beam irradiation
Prior or current therapy for prostate cancer
Asymptomatic patients with non-metastatic, biochemical progression of prostate cancer
Advanced prostate cancer
Previous or current hormonal management of prostate cancer (unless terminated at least 12 months prior to trial)
Prostate cancer
Patients with pathologically?confirmed N1 prostate cancer
Men with metastatic, castration resistant prostate cancer involving the bone, which is symptomatic or asymptomatic
Asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC)
Prior chemotherapy for castration resistant prostate cancer; neoadjuvant chemotherapy and chemotherapy given for hormone sensitive prostate cancer are allowed
Prostate cysts or prostate calcifications > 1 cm on ultrasound
No prior treatment for prostate cancer
Prostate cancer clinical stage T2a and below
Prostate size < 60 cc on transrectal ultrasound
Prior radiation therapy to prostate or prostate bed is allowed provided it occurred > 3 months before enrollment to the study
Patients with prior chemotherapy given for castrate-resistant prostate cancer
Prior chemotherapy for prostate cancer
Has had a prior radium treatment or treatment with other therapeutic radiopharmaceuticals for prostate cancer
For Cohort C: Has a history of prostate cancer progression on ketoconazole
Prior systemic biologic therapy, including immunotherapy, for prostate cancer;
Prostate volume ? 90 cc, on Baseline MRI
Prior definitive treatment of prostate cancer
Previous chemotherapy unless intervention was greater than 5 years from beginning treatment for prostate cancer
Subject has received any prior pharmacotherapy, radiation therapy or surgery for metastatic prostate cancer (the following exceptions are permitted):
Prior chemotherapy or immunotherapy for prostate cancer.
Asymptomatic prostate cancer;
Prostatic intraepithelial neoplasia without evidence of prostate cancer
Prior use of immunotherapy or chemotherapy for prostate cancer
Prior radiation therapy for prostate cancer
Prior investigational therapy for prostate cancer
Patients must have progressive, metastatic, castration-resistant prostate cancer (mCRPC) as defined below:
Any previous ablative procedures performed on the prostate, e.g., electroporation, radiofrequency ablation, high-intensity focused ultrasound (HIFU), cryosurgery, photochemical, thermal or microwave therapy to treat cancer of the prostate.
Metastatic, castrate resistant prostate cancer (M1 by National Comprehensive Cancer Network (NCCN) criteria)
Previous surgery for prostate cancer
Patients must have metastatic prostate cancer (clinical stage D1 or D2 disease), with previously documented lymph node, soft tissue and/or bone metastases by radiographic imaging (including computed tomography [CT] [or magnetic resonance imaging (MRI)] of abdomen and pelvis and bone scintigraphy); patients in situations in which there is a reasonable clinical suspicion of a second primary tumor (or other non-prostate cancer reason for radiographic abnormalities) are not eligible unless metastatic disease is histologically confirmed to be prostate cancer
Have an active malignancy other than prostate cancer that requires therapy
Prostate gland volume should be no greater than 70 cc, volumetrically measured.
History of orchiectomy, PCa-specific chemotherapy, cryotherapy, Photodynamic therapy or radical prostatectomy for treatment of prostate cancer; any prior radiation therapy to the pelvis for prostate cancer or any other malignancy.
Prostate size > 140 cc or pubic arch interference study demonstrating unacceptable prostate access by the transperineal approach
Prior treatment with chemotherapy for metastatic castration-resistant prostate cancer
Patient may have had prior systemic therapy and/or ADT associated with treatment of their primary prostate cancer; patient may have had ADT associated with salvage radiation therapy (to the primary prostate cancer or pelvis is allowed)
Castration-resistant prostate cancer (CRPC)
Prior salvage treatment to the primary prostate cancer or pelvis is allowed
No prior systemic therapy for metastatic prostate cancer
Received prior therapeutic intervention for metastatic prostate cancer
Prior ADT for prostate cancer (including bilateral orchidectomy), except in the following settings:
Participation in other clinical trials of investigational agents for the treatment of prostate cancer or other diseases.
Additionally, patients will be required to meet the following criteria \r\n* Karnofsky performance status (KPS) >= 70\r\n* Prostate volume =< 60 cc (cytoreductive androgen deprivation therapy prior to brachytherapy of =< 6 months duration will be allowed to achieve this goal); for patients with a prostate volume between 50-60 ccs, hormone therapy will be at the discretion of the physician\r\n* International Prostate Symptom Score =< 15
Previously treated with ketoconazole for prostate cancer for greater than 7 days
Patients diagnosed with prostate cancer that elect to undergo primary cryotherapy of the prostate
Prostate cancer progression
Subjects must have metastatic prostate cancer mass tissue collection within 3 months of study entry
Have pathologic diagnosis of prostate cancer
History of prostate cancer progression of ketoconazole
Prostate cancer progression documented by prostate specific antigen according to the Prostate Cancer Working Group 2 (PCWG2) criteria or radiological progression according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
Asymptomatic or mildly symptomatic prostate cancer.
Treatment with more than one chemotherapy agent for prostate cancer
Stage T4 prostate cancer by clinical examination or radiologic evaluation
COHORT A: Current or prior investigational therapies for prostate cancer, or chemotherapy administered with the intention to treat prostate cancer
COHORT B: Current or prior investigational therapies for prostate cancer, or chemotherapy administered with the intention to treat prostate cancer
Men with metastatic castration-resistant prostate cancer
More than 2 prior courses of chemotherapy for metastatic prostate cancer
Previous use of immunotherapy or radium-223 for the treatment of metastatic prostate cancer
Asymptomatic or mildly symptomatic from prostate cancer
Previous treatment with ketoconazole for prostate cancer for greater than 7 days
Prior treatment with radiopharmaceutical agents, or any other investigational agent for non-metastatic castration-resistant prostate cancer
Previously treated with ketoconazole for prostate cancer for greater than 7 days
Prior radiotherapy to the prostate or pelvis (related to prostate cancer); concurrent adjuvant radiation therapy is permitted once patient has been enrolled on trial
Asymptomatic or mildly symptomatic from prostate cancer; no use of regularly scheduled opiate analgesics for prostate cancer-related pain
Patients with prior chemotherapy for nonmetastatic prostate cancer within a year are excluded
No prior radiation or chemotherapy for prostate cancer treatment
Clinical evidence of metastatic prostate cancer
History of progression of prostate cancer while receiving ketoconazole
The subject has received chemotherapy for castration-resistant prostate cancer
Have a histologic or cytologic diagnosis of prostate cancer
Patients must not have been treated with a prior vaccine therapy for prostate cancer
E 01. Prior chemotherapy for prostate cancer,
Biopsy-proven (consisting of >= 10 tissue cores) adenocarcinoma of the prostate diagnosed within 24 months prior to pre-registration            \r\n* < 25% of biopsy tissue cores positive for cancer\r\n* =< 50% of any one biopsy tissue core positive for cancer\r\n* Clinical stage =< T2a\r\n* Patients who have prostate cancer with distant metastases are not eligible\r\nNOTE: if a patient undergoes a transurethral resection of the prostate (TURP) for benign prostatic hyperplasia (BPH), and prostate cancer is diagnosed incidentally from the TURP specimen, eligibility for CALGB 70807 cannot be determined from the TURP specimen; however, if the patient subsequently undergoes a minimum 10-core prostate biopsy within 2 years of prostate cancer diagnosis from the TURP, and prostate cancer is detected in the biopsy specimen and meets the requirements above, the patient is eligible for this study; if prostate cancer is not detected in the biopsy specimen, the patient is not eligible
Asymptomatic or mildly symptomatic from prostate cancer
prostate biopsy with ?10 core biopsies demonstrating 1 or more cores positive for cancer cells, within 6 months prior to treatment;
prostate volume ? 40 gms(cc) (HIFU subject prostate volume will be initially calculated utilizing TRUS measurements during screening and verified with the use of the Sonablate before initiating the HIFU procedure. Patients with prostate volumes greater than 40 gm(cc) as determined by either measurement will not be enrolled in the study);
prior treatment for prostate cancer, other than EBRT or hormone therapy;
prostate seroma/abscess;
Metastatic asymptomatic or minimally symptomatic castration-resistant prostate cancer (CRPC) patients who are eligible for sipuleucel-T
asymptomatic prostate cancer without known metastatic disease and with no current requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for ? 1 year prior to enrollment, or
If < 3 cores then at least one prostate core must contain >= 30% prostate cancer
Have a confirmed diagnosis of prostate cancer
localized prostate cancer
No other systemic therapies for prostate cancer within 28 days prior to initiation of this protocol
No history of radiopharmaceuticals (strontium, samarium) for prostate cancer treatment
Metastatic, castrate resistant, histologically confirmed prostate cancer; surgically castrated or continuous medical castration for ? 8 weeks prior to screening
No treatment for prostate cancer has been administered or will be administered before TRUS guided biopsy
Histologically confirmed adenocarcinoma of the prostate\r\n* In situations where pathology reports documenting prostate cancer are no longer available such as when the initial biopsy or prostatectomy was performed in the remote past, a documented history of prior prostate cancer and prostate cancer treatment in prior medical records will be sufficient
Metastatic prostate carcinoma and at least one of the following:
Patients with known evidence of active cancers, or other cancer under active treatment; exceptions include patients with no evidence of disease receiving adjuvant hormone-based therapy or either breast or prostate cancer
Patients may not have received any prior pharmacologic therapy or RT for prostate cancer
Prostate cancer with the following pathological characteristics:\r\n* Gleason sum >= 8 AND at least 2 discrete core biopsies containing a minimum of 20% cancer OR\r\n* Gleason pattern 4 + 3 = 7 AND greater than 50% of biopsies positive for prostate cancer
Up to 6 patients with castration-resistant prostate cancer (CRPC) that was pathologically confirmed as adenocarcinoma of the prostate and with evidence of metastatic disease on bone scan or other imaging. Patient must have progressive disease after at least one hormonal treatment and one cytotoxic therapy e.g. with docetaxel, mitoxantrone.
Patients who have had chemotherapy for metastatic castration-resistant prostate cancer
Prior ketoconazole for prostate cancer
Prior chemotherapy for prostate cancer
Metastatic castration-resistant prostate cancer (CRPC)
Prior ketoconazole for prostate cancer
Primary diagnosis of prostate cancer selected for surgical intervention by one of the six protocol surgeons (Chapin, Davis, Matin, Pettaway, Pisters, Ward)
Have had prior or current prostate cancer therapies:
Biologic therapy for prostate cancer
Chemotherapy for prostate cancer
Radiotherapy for prostate cancer,
Prior chemotherapy for prostate cancer
Past history of prostate cancer or non-Hodgkin’s lymphoma with only active surveillance (i.e., no surgery, chemotherapy, or radiation therapy)
Patient has a primary diagnosis of localized prostate cancer (T1; T2, N=0 M=0; T3, N=0, M=0)
Patient has had previous definitive treatment for localized prostate cancer
Must be diagnosed with prostate cancer and on active surveillance within the past 36 months (or the spouse or significant other of someone with prostate cancer on active surveillance)\r\n* While AS criteria for each program varies slightly, all programs use the following clinical and pathological criteria:\r\n** Clinical stage T1c or T2a prostate cancer, verified by a participating urologist\r\n** Diagnosis of prostate cancer made on a 12 core needle biopsy (if any of this information was unavailable prior to consent or on the diagnostic biopsy report, the eligibility was contingent on either urologist review of the diagnostic biopsy or the pathological data from the confirmation biopsy)\r\n** Biopsy Gleason score =< 6 OR Gleason score 7 (3+4 ONLY), with =< 3 cores positive
Have pursued any active therapy for prostate cancer will be excluded.
Subjects may have received up to one or two doses of their planned chemotherapy prior to enrollment; otherwise the restrictions for prior therapy:\r\n* Breast cancer subjects may have received curative-intent chemotherapy for a separate malignancy more than 3 years ago\r\n* Prostate cancer subjects may have received prior treatment with metronomic cyclophosphamide as this is considered anti-angiogenic/immunomodulatory and not cytotoxic\r\n* Prostate cancer subjects may be receiving a 2nd course of docetaxel provided that \r\n** The first course resulted in a prostate specific antigen (PSA) response (> 30% reduction in PSA and/or improvement in radiographic findings or pain) and the last dose was >= 9 months ago
Men with a new histologic diagnosis of localized prostate cancer
Individuals with a medical condition that necessitates a specific prostate cancer treatment plan
Prior chemotherapy, radiation therapy for the treatment of prostate cancer, or immunotherapy for prostate cancer
Metastatic prostate cancer (hormone-sensitive, de novo, or castration resistant)
Prostate cancer diagnosed at age =< 55 years
Prostate cancer diagnosis and a family history potentially indicating a germline mutation (e.g. breast cancer diagnosed at age =< 50, ovarian, pancreatic, uterine, colorectal, prostate cancer or sarcoma, in one or more first or second degree relatives)
Localized prostate cancer previously treated and in remission for >= 2 years
PROSTATE CANCER COHORT:
Any active malignancies being treated other than bladder cancer (incidentally found prostate cancer at RC is acceptable).
Men who do not reside in one of the four neighborhoods, who self-report that they have previously been diagnosed with prostate cancer, or who have had prostate cancer screening (prostatic specific antigen [PSA] or digital rectal examination [DRE]) within the past 12 months
Patients with prostate cancer
Diagnosed with prostate cancer
Not diagnosed with prostate cancer
Not receiving or planning to receive ADT for prostate cancer treatment within the last three months
Initiating ADT for prostate cancer prior to the previous 3 months or are not on ADT holiday
Diagnosis of prostate cancer
Diagnosis of prostate cancer
Has been diagnosed with localized prostate cancer (i.e. pathologically and/or radiographically confirmed)
Has no other active primary malignancy aside from prostate cancer
Has NOT been diagnosed with localized prostate cancer (i.e. pathologically and/or radiographically confirmed)
Has other active primary malignancy aside from prostate cancer
Any prior chemotherapy for castrate-resistant prostate cancer
Previous prostate surgery
PROSTATE CANCER: Histologically confirmed prostate cancer
Any prior or concurrent treatment for prostate cancer
Asymptomatic, or minimally symptomatic from prostate cancer or prostate cancer related therapies\r\n* No opioid-requiring cancer related pain \r\n* Any therapy related genitourinary or gastrointestinal symptoms should be considered as mild (Common Terminology Criteria for Adverse Events [CTCAE] grade 1 or 2) and not interfering with activities of daily living
Subjects without a diagnosis of prostate cancer.
Prior surgery or radiation therapy for prostate cancer
Have non-metastatic prostate cancer and =< clinical T3a disease at diagnosis
Receiving hormonal therapy for prostate cancer
Metastatic, castrate resistant, histologically confirmed prostate cancer; surgically castrated or continuous medical castration for ? 8 weeks prior to screening
urothelial, SCHNN, prostate, soft tissue sarcoma, prostate cancer, TNBC, ccRCC, NSCLC: 1-5 prior treatments
Having completed definite treatment of localized prostate cancer (surgery or radiation)
Prostate cancer (PCa) diagnosis
History of prior prostate biopsy in the last 5 years
Prior diagnosis of prostate cancer
Arm 1 patients must have treatment-naive, Gleason >= 7 prostate cancer based on transrectal ultrasound (TRUS) or prostate mapping biopsy, have localized disease, and have decided to undergo radical prostatectomy (open or robotic) as definitive treatment for their prostate cancer
Men who will be undergoing transrectal ultrasound of the prostate with biopsy for the evaluation of prostate cancer in the Division of Urology at City of Hope, or at participating urology clinics
Men with a previous diagnosis of prostate cancer
Men without a prior diagnosis of prostate cancer but who have previously undergone a biopsy for a suspicious DRE or PSA
Risk of prostate cancer 20-60% calculated with the on-line PCPT prostate cancer risk calculator; PSA value must be obtained within 3 months prior to study entry
Prior history of prostate cancer
Diagnosed with prostate cancer
Have a prostate cancer diagnosis
Diagnostic prostate biopsy with only 1 core with cancer and < 5% of tissue from that core involved with cancer
Castration-resistant prostate cancer
No concurrent treatment (hormonal, radiation or systemic chemotherapy) for prostate cancer during study enrollment is planned (unless participants demonstrate clinical evidence of prostate cancer progression such as symptoms, physical exam findings, a rapidly increasing PSA, or radiologic findings which confirm disease progression)
Subjects with a prostate volume of >80mL
Current investigational therapy for prostate cancer
SUB-STUDY I: Chemotherapy for prostate cancer
SUB-STUDY II: Chemotherapy for prostate cancer
SUB-STUDY III: Investigational therapy for prostate cancer less than 28 days prior to study PET imaging
Men with prostate cancer and known bone metastases planned for new systemic therapy and/or radiotherapy and who have a planned clinically indicated staging multi-detector computed tomography (MDCT)
Histological diagnosis of adenocarcinoma of the prostate OR has a clinical diagnosis of prostate cancer and on active therapy or has received treatment for prostate cancer
Suspected prostate cancer based on elevated PSA level (>= 4) and abnormal digital rectal examination with clinical decision to proceed to prostate biopsy
Have an active malignancy other than prostate cancer that requires therapy
Patient must not have had any prior treatment for prostate cancer
Prostate volume 20 - 100 cc
Chemotherapy for prostate cancer
Investigational therapy for prostate cancer
The patient must have either 1) an established diagnosis of pancreatic cancer by biopsy or 2) cancer involving the liver by biopsy or radiographic criteria, or 3) prostate cancer by biopsy, with the intent of undergoing definitive dose radiation therapy to targets within the pancreas, liver, or prostate; patients with prostatectomy receiving post-operative radiotherapy are also eligible
INCLUSION CRITERIA (NEXT 60 PATIENTS WITH LOCALLY ADVANCED PROSTATE CANCER): Histological confirmation of prostate cancer
Patient cannot start a new therapy for prostate cancer prior to study radiopharmaceutical imaging
Males scheduled for prostate biopsy (for known or suspected prostate cancer) followed by planned prostatectomy (population group A), or
Plan to undergo external radiation treatment of prostate cancer
Patients who have had chemotherapy or radiotherapy within 12 months of the study for other diagnoses not related to prostate cancer
Investigational therapy for prostate cancer
Minimum 10 core prostate biopsy showing histologically-confirmed prostate cancer within 12 months of enrollment reviewed by a pathologist from one of the Dana Farber (DF)/Harvard Cancer Center (HCC) associated hospitals
First diagnosis of prostate cancer > 12 months prior to enrollment
Patient is diagnosed with >= stage 3 breast cancer or >= stage 2 prostate cancer (and/or prostate-specific antigen [PSA] > 10 micrograms/L), including patient with recurrent breast or prostate cancer
Subject must be scheduled for a clinically indicated needle biopsy of the prostate based upon an elevated prostate specific antigen (PSA), abnormal digital rectal examination, or based upon active surveillance of prostate cancer
Previous treatment for prostate cancer (PCa)
Investigational therapy for prostate cancer
Known prostate cancer with a clinical concern for the presence of metastatic disease as delineated below:\r\n* Population 1: treatment naive patients with one of the following risk factors: Cancer of the Prostate Risk Assessment (CAPRA) score >= 5, PSA >= 15 ng/mL and/or Gleason score >= 4+4\r\n* Population 2: patients with biochemical recurrence after prostatectomy or radiation therapy with a PSA doubling time less than 12 months\r\n**These patients may have received androgen deprivation therapy prior to imaging\r\n* Population 3: patients with castrate resistant prostate cancer with progressive disease as defined by Prostate Cancer Working Group 2 (PCWG2) criteria \r\n** Patients with castrate resistant prostate cancer can be either on treatment or off treatment
Prostate biopsy must be reviewed at Brigham and Women’s Hospital or the Dana Farber Cancer Institute and should support a diagnosis of stage I-III prostate adenocarcinoma
Known diagnosis of prostate cancer
No prior treatment for prostate cancer
Minimal tumor burden as defined by at least one of the following criteria:            \r\n* One single core with >= 50% cancer burden and >= 5 mm tumor length\r\n* Two or more cores in the same prostate region, each with >= 30% cancer burden\r\n* Three or more cores positive for prostate cancer (of any magnitude of cancer burden) in the same prostate region\r\n* Gleason score of 7 or higher cancer burden\r\n* Prostate-specific antigen (PSA) >= 10 ng/mL
Individuals who have previously undergone biopsy of the prostate for diagnosis of prostate cancer
A diagnosis of prostate adenocarcinoma on more than one set of prostate biopsies, on separate calendar dates
ARM I ONLY: For patients with presumed localized disease (any T, N0, M0), a multiparametric MRI (standard of care at the National Institutes of Health [NIH] Clinical Center) must be performed within 4 months of the 18F-DCFBC injection with findings suggestive for prostate cancer and a prostate lesion at least 6 mm or greater; must have histopathologic confirmation of prostate cancer prior to 18F-DCFBC imaging
Disease status: unfavorable intermediate to high-risk prostate cancer, Cancer of the Prostate Risk Assessment Score (CAPRA 5-10)
Men at least 18 years of age referred with clinical suspicion of prostate cancer who have been advised to have a prostate biopsy
Prior treatment for prostate cancer
Subjects with clinically localized prostate cancer (outside pathology is acceptable) must have image guided biopsy confirmed prostate cancer and sufficient tissue available (obtained before or after 20 weeks of Eovist® injection) for OATP1B3 expression
Men with prostate cancer who elect surgery as the primary treatment of their cancer and to be performed at the Moffitt Cancer Center
Biopsy confirmed prostate cancer with at least ten biopsies performed for diagnosis
Known diagnosis of prostate cancer
Known prostate cancer
Any prostate size
History of prostate cancer
Patients preparing to receive systemic therapy to treat metastatic castration-resistant prostate cancer
Minimally-symptomatic or asymptomatic, castrate-resistant metastatic prostate cancer, as evidenced by all of the following:\r\n* Histologically-confirmed diagnosis of adenocarcinoma of the prostate\r\n* Evidence of adequate androgen deprivation, as evidence by one of the following:\r\n** Bilateral orchiectomy\r\n** Ongoing luteinizing hormone-releasing hormone (LHRH) agonist (e.g. leuprolide, goserelin) and serum testosterone =< 50 ng/dl\r\n** Ongoing LHRH antagonist (e.g. degarelix) and serum testosterone =< 50 ng/dl\r\n* Evidence of prostate cancer resistance to castration, as evidenced by at least one of the following:\r\n** 2 consecutive prostate-specific antigen (PSA) levels that are >= 50% above the PSA nadir achieved on androgen deprivation therapy (ADT) and obtained at least 1 week apart\r\n** Computed tomography (CT) or magnetic resonance imaging (MRI) based evidence of disease progression (soft tissue or nodal) according to Prostate Cancer Working Group 2 (PCWG2) criteria or Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria, or at least 1 new bone scan lesion as compared to the most immediate prior radiologic studies\r\n* Presence of non-visceral metastases on imaging\r\n* Absence of major symptoms directly attributable to prostate cancer, with the following permissible exceptions:\r\n** Ureteral obstruction secondary to pelvic or retroperitoneal lymphadenopathy\r\n** Bladder outlet obstruction secondary to locally recurrent prostate cancer
Patients who have received systemic chemotherapy for prostate cancer will not be eligible
Any prior treatment for prostate cancer
For participants with metastatic castrate-resistant prostate cancer only:
Patients must have prostate biopsy within 4 months prior to registration showing newly diagnosed prostate cancer, stage T1-3N0M0; in addition, patients must have: Gleason score 6-10
Confirmed diagnosis of prostate cancer
Self-reported prostate cancer diagnosis
Men with a history of prostate cancer
Men with known prostate volume (from prior imaging) of > 60cc
Patients with known or suspected prostate cancer who have been referred to the Department of Radiology at the University of Chicago Medical Center for a diagnostic MRI exam of the prostate, to be followed by an MRI-guided fusion biopsy of the prostate
Prostate size volume ?90 cc
Hormone sensitive relapsing prostate cancer after definitive local therapy (biochemical relapse) OR
Concurrent immunotherapy for prostate cancer
The maximum time requirement between surgery and randomization must be:\r\n* 3 months (90 days) if no adjuvant chemotherapy was administered\r\n* 8 months (240 days) if adjuvant chemotherapy was administered\r\n* 10 months (300 days) if adjuvant chemotherapy and radiation therapy were administered
Patients must have completed any prior adjuvant chemotherapy or radiation therapy 2 or more weeks (6 or more weeks for mitomycin and nitrosoureas) prior to randomization and be adequately recovered at the time of randomization\r\n* NOTE: Patients taking low dose methotrexate for non-malignant conditions and other cytotoxic agents for non-malignant conditions are allowed to continue treatment while on study\r\n* NOTE: Neo-adjuvant chemotherapy or radiation therapy for the resected lung cancer is not permitted
No postoperative/adjuvant systemic therapy
Patients who received neo/adjuvant therapy must be after last dose of chemotherapy and/or biologic therapy and must have sufficient resolution of side effects.
Interval between the last surgery for breast cancer (including re-excision of margins) or the completion of adjuvant chemotherapy and study enrollment must be =< 56 days (ie, a maximum of 8 weeks)\r\n* Note: Radiotherapy must begin within 10 weeks following the last surgery for breast cancer or the last dose of adjuvant chemotherapy
Participants who have completed neo-adjuvant or adjuvant therapy with a platinum doublet and have experienced disease recurrence within 6 months of completing the platinum doublet are eligible.
Patients must not have received prior chemotherapy except for the following circumstances; gemcitabine and capecitabine chemotherapy given in the adjuvant setting is allowed if the recurrence is greater than 6 months from the completion of chemotherapy; radiation sensitizing doses of 5-fluororuracil or capecitabine are allowed as part of adjuvant treatment and recurrence must be documented greater than 6 months from the completion of adjuvant therapy
No prior systemic treatment for unresectable locally advanced or metastatic disease for the tumor type under study. If prior systemic chemotherapy treatment was given in the adjuvant or neo-adjuvant setting or as part of radiotherapy chemotherapy treatment, disease-free interval after stop of systemic treatment must be more than 6 months for non-squamous NSCLC and more than 12 months for UC;
Any prior treatment for metastatic breast cancer (excluding radiation therapy for the purpose of ovarian ablation). Note: prior adjuvant therapy with trastuzumab and pertuzumab is permitted after a 6-month window following completion of adjuvant therapy has passed
Any prior systemic therapy (e.g. adjuvant, neo-adjuvant or concurrent use of chemotherapy, immunotherapy or an investigational agent) for MCC at any time
Participant has received more than 4 prior lines of systemic cytotoxic therapy (not including neo-adjuvant or adjuvant therapy).
Cohort B:\r\n* Must have received prior trastuzumab, pertuzumab, and T-DM1 in neo-adjuvant, adjuvant, or metastatic setting\r\n* No limit on prior lines of therapies
Cohort C:\r\n* Must have received prior trastuzumab, pertuzumab, and T-DM1 in neo-adjuvant, adjuvant, or metastatic setting\r\n* Maximum of 5 prior lines of therapy for metastatic breast cancer\r\n* Prior treatment with fulvestrant is permitted
Patients must be newly diagnosed metastatic or must have relapsed following a prior (neo)adjuvant chemotherapy regimen. If a taxane (i.e., paclitaxel or docetaxel) was administered as part of the (neo)adjuvant regimen, PD must have occurred > 12 months from the end of previous (neo)adjuvant treatment. For non-taxane (neo)adjuvant regimen, PD must have occurred > 6 months from the end of previous (neo)adjuvant treatment
ADJUVANT COHORT: At least 4 weeks post completion of adjuvant chemotherapy and radiation therapy if indicated
Participants can have no prior history of any EGFR-directed therapy, including tyrosine kinase inhibitors (TKIs) or antibodies, and must also be chemotherapy and immunotherapy naive for metastatic disease; patients who have completed adjuvant or neo-adjuvant chemotherapy > 6 months ago are considered treatment naive
Part A: Subjects must have one of the histologically-confirmed solid malignancies listed below, must be clinically disease-free at study entry (i.e., subjects in the adjuvant setting). Subjects will be permitted to complete any standard of care adjuvant therapy prior to study entry, and those not eligible for any standard of care adjuvant treatment, or who decline such treatment, are permitted to consent to this study, as long as all treatment options have been transparently disclosed and documented in the Subject's medical record
Participants can have no prior history of any EGFR-directed therapy, including tyrosine kinase inhibitors (TKIs) or antibodies, and must also be chemotherapy and immunotherapy naive; patients who have completed adjuvant or neo-adjuvant chemotherapy or immunotherapy > 6 months ago are considered treatment naive
Patients must have failed or are intolerant to one line of systemic treatment but no more than 3 prior lines of systemic chemotherapy for advanced BTC; patients who received adjuvant chemotherapy and had evidence of disease recurrence within 6 months of completion of the adjuvant treatment are also eligible; if the patient received adjuvant treatment and had disease recurrence after 6 months, patients will only be eligible after failing or having intolerance to one line of systemic chemotherapy used to treat the disease recurrence
SPECIFIC FOR INITIATING ADJUVANT PEMBROLIZUMAB: Patient is receiving adjuvant radiation after salvage surgery
No prior adjuvant chemotherapy within 1 year of the first treatment day if there is recurrent disease
Previous chemotherapy except adjuvant treatment with progression of disease documented ? 12 months after end of adjuvant treatment
Subjects must have finished adjuvant therapy, which can include chemotherapy and/or chemoradiation therapy or have been determined to be unable to take adjuvant therapy; although patients will be expected to complete chemoradiation or chemotherapy per physician recommendations, patients who are unable to complete chemotherapy +/- radiation therapy secondary to dose limiting toxicities will be eligible provided they meet study criteria
Subjects enrolled due to node positive (+) disease or R1 resection must be able to undergo randomization within 3 months of finishing adjuvant therapy or the decision that they are unable to take adjuvant therapy; patients enrolling due to CA 19-9 elevations can enroll any time after adjuvant therapy has completed
No prior chemotherapy for metastatic/recurrent disease; prior adjuvant or neo-adjuvant treatment with a fluoropyrimidine or fluoropyrimidine based regimen is allowed only if it is completed at least 6 months prior to the start of study drug, whether given alone or with radiation therapy; patients who have received prior neo-adjuvant therapy (chemotherapy and/or radiation therapy) which did not contain fluorouracil (5-FU) or capecitabine and have been diagnosed with metastatic disease (with no previous treatment in the metastatic setting) are eligible; no 6-month window is required for these patients; in the setting of metastatic disease requiring local palliation, only radiosensitizing doses of 5-FU or capecitabine monotherapy are permitted
The subject has demonstrated radiographic progression after front-line treatment for locally advanced or metastatic disease (prior adjuvant therapy allowed if >= 6 months elapsed between end of adjuvant therapy and metastatic relapse)
Prior chemotherapy:\r\n* Patients may have received 1-3 prior therapies for metastatic disease (note: for patients who have first developed recurrent/metastatic disease within 12 months of completing any (neo)-adjuvant therapy for triple-negative breast cancer, the (neo)-adjuvant therapy is counted as a prior line of therapy)\r\n* Patients must have been off treatment with myelosuppressive chemotherapy for at least 21 days or nonmyelosuppressive agents for 14 days before registration; patients should also be adequately recovered (to baseline or grade 1) from acute toxicities of prior treatment except for residual alopecia and peripheral neuropathy
At eligibility recheck prior to vaccination, the above criteria must be met plus:\r\n* Completed adjuvant chemotherapy:\r\n** Initiation of adjuvant chemotherapy within 12 weeks of surgery\r\n** Completion of at least 4 months of adjuvant chemotherapy with gemcitabine/capecitabine or similar adjuvant chemotherapy at the discretion of the patient’s medical oncologist\r\n** Additional chemoradiation therapy as recommended by the patient’s medical oncologist\r\n** Reimaging within 4 weeks of last dose of chemotherapy demonstrates no evidence of recurrent disease and CA 19-9 is less than 92.5 u/mL\r\n** Dose modifications and/or delays in adjuvant chemotherapy is at the discretion of the treating physician\r\n* Neoadjuvant chemotherapy is exclusionary\r\n* There is a 1 week washout prior to day 1 of vaccine for patients on daily systemic steroids at doses exceeding 10 mg prednisone
Patients treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy; patients who progress more than 6 months after completion of oxaliplatin containing adjuvant treatment must be retreated; patients who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to progression of disease will also be allowed in the study
Completion of adjuvant locoregional radiation, if indicated, is required prior to starting study treatment
No prior line of systemic therapy for metastatic disease. Prior adjuvant or neo-adjuvant chemotherapy or radiochemotherapy (other than nab-paclitaxel) is allowed if completed ?3 months prior to enrollment and no lingering toxicities are present.
Patients must have completed all primary therapy (definitive surgery, (neo)adjuvant chemotherapy adjuvant radiation and/or Her2-directed therapy) for the index malignancy at least 4 weeks prior to study entry; all prior treatment-related toxicity must be resolved prior to study enrollment; concurrent receipt of adjuvant endocrine and bone modifying agents is allowed per standard of care guidelines
Patients who received (neo) adjuvant therapy for breast cancer are eligible. If the prior neo (adjuvant) therapy included letrozole or anastrozole the disease free interval must be greater than 12 months from the completion of treatment until study entry.
History of another primary cancer diagnosis, treated with adjuvant chemotherapy
Patients who received adjuvant chemotherapy plus or minus radiation and had evidence of disease recurrence within 6 months of completion of the adjuvant treatment are NOT eligible; if patients received adjuvant treatment and had disease recurrence after 6 months, patients will be eligible
Pre-operative (neo-adjuvant) platinum based or other chemotherapy
ARM A COHORT 1: Patients must not have received prior therapy for metastatic or advanced disease; adjuvant therapy that is gemcitabine based is allowed as long as the adjuvant treatment was completed >= 6 months before the diagnosis of recurrent disease
Subject has had cytoreductive surgery and has completed first line platinum based chemotherapy in an adjuvant or neo-adjuvant setting as part of standard of care treatment
Pre-operative (neo-adjuvant) platinum based or other chemotherapy is not permissible.
No prior anticancer therapy for treatment of NSCLC other than standard post-operative adjuvant chemotherapy is permissible. Radiation: • Patients with N2 disease only who receive adjuvant post-operative radiation therapy are eligible provided they meet the protocol specified timing criteria for surgery, adjuvant chemotherapy and randomization. Pre-operative radiation therapy is not permissible.
Patient has prior history of intolerance to adjuvant interferon-alpha therapy
Adjuvant therapy will not count towards prior treatment for metastatic disease, unless the patient relapsed within 1 year of completing adjuvant therapy
Subject has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, subject may have received either neo-adjuvant or adjuvant chemotherapy as long as it was completed at least 6 months prior to the first dose of study treatment.
Prior chemotherapy, adjuvant therapy, or radiotherapy for gastric cancer
Candidate to receive adjuvant or neo-adjuvant TC chemotherapy.
Concurrent adjuvant cancer therapy.
Patients undergoing neo-adjuvant systemic therapy.
Chemotherapy naïve or 1 prior chemotherapy regimen in the adjuvant setting (Prior taxane-based adjuvant therapy allowed provided patient had a disease-free interval of at least 12 months after completing this adjuvant therapy)
Must be naive to systemic treatment for NSCLC. Patients who received adjuvant or neo-adjuvant chemotherapy are eligible if at least 6 months have passed since last treatment.
Must be deemed as a good candidate for adjuvant chemotherapy or chemoradiation (to start within 3 months of surgery), in the opinion of the treating investigator. Plan must be to start adjuvant therapy within 90 days of surgery; adjuvant treatment cannot begin more than 90 days after surgery.
Prior adjuvant chemotherapy is allowed, as long as a minimum of 3 months (for pancreatic cancer) and 6 months (for colorectal cancer) has passed between the completion of adjuvant therapy and the start of first line therapy
Patients who received prior neo-adjuvant, adjuvant chemotherapy or chemo-radiation or radiation with curative intent for non-metastatic NSCLC must have experienced a treatment-free interval of at least 6 months from signing the informed consent since the last chemotherapy or chemo-radiation or radiation treatment/cycle
Previous treatment with less than or equal to 1 prior chemotherapy (excluding prior\n             neo-adjuvant or adjuvant chemotherapy or chemoradiotherapy with curative intent)
Previous neo-adjuvant or adjuvant treatment is allowed provided that it was given >= 6 months prior to registration
PHASE II: Previous neo-adjuvant or adjuvant treatment is allowed provided that there was no evidence of recurrent disease for at least 6 months after completion of neo-adjuvant/adjuvant treatment
Approved adjuvant therapies, which may include molecularly-targeted agents, IFN ?, and ipilimumab. Patients who received ipilimumab as adjuvant therapy must have a 6 month washout before receiving any dosing on this study
At least 3 weeks (21 days) must have passed since the completion of adjuvant chemotherapy or radiotherapy
relapsed with documented evidence of progression while on (neo) adjuvant endocrine therapy or within 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease;
Patient who relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease
nab-Paclitaxel + Nivolumab and nab-paclitaxel, Gemcitabine and Nivolumab: Subjects must have received no previous systemic chemotherapy or investigational therapy for the treatment of pancreatic adenocarcinoma, including neo-adjuvant or adjuvant therapy, with the exception of prior treatment administered as a radiosensitizer concomitant with radiotherapy in the adjuvant setting. In this case, ? 6 months must have elapsed since completion of the last dose and no lingering toxicities may be present. Initial diagnosis of metastatic disease must have occurred ? 6 weeks prior to randomization in the study.
Subjects must have received no previous chemotherapy or investigational therapy for the treatment of metastatic disease. Adjuvant, neo-adjuvant chemotherapy or chemoradiotherapy is permitted providing cytotoxic chemotherapy was completed > 12 months prior to randomization, without disease recurrence or progression during those 12 months.
All patients should have received at least one line of chemotherapy in either the advanced or neo/adjuvant setting and hormonal therapy (where appropriate); participants who have previously been treated with endocrine therapy only, and later develop triple negative disease are eligible as long as they have had one line of chemotherapy in either the advanced or neo/adjuvant setting
Completed primary treatment (surgery and radio/chemotherapy in adjuvant and/or neo-adjuvant setting) <360 days prior to first vaccination.
Subjects who have either received chemotherapy for metastatic disease or are considered by the treating investigator to be appropriate candidates for chemotherapy as current treatment for metastatic breast cancer are excluded. Chemotherapy administered for adjuvant/neo adjuvant disease is acceptable.
For participants who have received prior neo-adjuvant/adjuvant chemotherapy or chemoradiotherapy with curative intent for non-metastatic disease: a treatment-free interval of at least 6 months prior to enrollment
Candidate to receive adjuvant or neo-adjuvant TC chemotherapy.
Concurrent adjuvant cancer therapy
relapsed with documented evidence of relapse more than 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for advanced/metastatic disease
relapsed with documented evidence of relapse on or within 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for advanced/metastatic disease
Have not received any prior first-line systemic therapy (prior adjuvant or neo-adjuvant therapy is permitted). Participants whose disease has progressed after >12 months following the last dose of systemic treatment in the adjuvant/neoadjuvant setting are eligible.
Patients who received (neo) adjuvant therapy for breast cancer are eligible
Have received prior (neo)adjuvant endocrine therapy with a disease-free interval ?12 months from completion of treatment
Prior treatment with letrozole in (neo)adjuvant setting with disease-free interval ? 12 months from completion of treatment until randomization.
Prior treatment with any anti HER-family targeted therapy in (neo)adjuvant setting.
Prior (neo)adjuvant treatment with letrozole or anastrozole with DFI ? 12-months from completion of treatment.
Patients must have undergone prior standard therapy of radiation therapy, and adjuvant chemotherapy
Prior trastuzumab and/or chemotherapy (taxanes included) as neo-adjuvant or adjuvant treatment is allowed but should be discontinued > 12 months prior to randomization.
Participant completed (neo) adjuvant taxane therapy at least 6 months prior to randomization
Participant completed (neo) adjuvant biologic therapy at least 6 weeks prior to randomization
Participant may have received prior hormonal therapy for breast cancer in the (neo) adjuvant and/or the metastatic setting ? 2 weeks prior to randomization
No prior treatment for metastatic disease (prior neo-adjuvant or adjuvant chemotherapy, except FOLFIRINOX, chemoradiation or radiation allowed)
Planned paclitaxel at a dose of 80 mg/m^2 intravenously (I.V.) given, in the adjuvant breast cancer (postoperative or neo-adjuvant) setting, every week for a planned course of 12 weeks without any other concurrent cytotoxic chemotherapy (NOTE: trastuzumab and/or other antibody and/or small molecule treatment is allowed, except for poly adenosine diphosphate ribose polymerase [PARP] inhibitors), at the entering Academic and Community Cancer Research United (ACCRU) institution
ii) Within 12 months of peri-operative (neo-adjuvant or adjuvant) treatment with a platinum agent in the setting of cystectomy for localized muscle-invasive urothelial cancer
Patients must be treatment-naïve for locally advanced or metastatic NSCLC and eligible to receive first-line treatment with gefitinib or erlotinib as selected by the participating centre. Prior adjuvant and neo-adjuvant therapy is permitted(chemotherapy, radiotherapy, investigational agents).
• Prior neo-adjuvant or adjuvant chemotherapy treatment within 6 months prior of starting 1st EGFR TKI treatment
Patients must have failed no more than 2 prior line of systemic chemotherapy for advanced biliary cancer; patients who received adjuvant chemotherapy and had evidence of disease recurrence within 6 months of completion of the adjuvant treatment are also eligible; if patient received adjuvant treatment and had disease recurrence after 6 months, patients will only be eligible after failing one line of systemic chemotherapy used to treat the disease recurrence
Patients previously treated with chemotherapy for mCRPC; at least 12 months must have elapsed from chemotherapy given in the adjuvant or neo-adjuvant setting
Subjects in the dose-escalation component can have had up to 1 prior line of systemic therapy. Subjects with pancreatic carcinoma to be enrolled in the MTD expansion cohort must have untreated, measurable metastatic disease. Subjects for the MTD cohort may have received prior adjuvant gemcitabine or fluoropyrimidine based therapy in the adjuvant setting provided more than 6 months has elapsed following completion of adjuvant therapy.
Participants may or may not have received (neo) adjuvant chemotherapy, but must be at least 30 days after last dose of chemotherapy and/or biologic therapy, with no more than grade 1 residual toxicity at the time of screening
Patients who received (neo) adjuvant therapy for breast cancer are eligible. If the prior neo (adjuvant) therapy included letrozole or anastrozole the disease free interval must be greater than 12 months from the completion of treatment until randomization.
Any previous chemotherapy, biologic therapy, or investigational agent, except for adjuvant therapy or as radio-sensitizing agents limited to 5-fluorouracil/capecitabine and gemcitabine; patient must have completed adjuvant therapy no less than six months prior to accrual
Prior bevacizumab in the neo/adjuvant or metastatic setting is acceptable
Prior treatment with ADT for biochemically relapsed prostate cancer. Prior ADT as neo-adjuvant, concurrent, and/or adjuvant treatment following salvage radiation therapy or prostatectomy for biochemically relapsed disease is allowed provided last dose of ADT is greater than (>) 6 months prior to randomization and the Screening serum testosterone level is greater than or equal to (?)150 ng/dL
Disease-free interval from completion of adjuvant/neo-adjuvant systemic non-hormonal treatment to recurrence of within 6 months
Subjects must have previously untreated locally advanced or metastatic pancreatic adenocarcinoma; patients newly diagnosed with metastatic recurrence after history of adjuvant therapy for resected disease are eligible, if completion of adjuvant therapy was greater than 8 months ago
Prior systemic chemotherapy for stage IIIB or IV non-small cell lung cancer. Neo-/adjuvant chemotherapy, chemoradiation or radiotherapy is permitted if at least 12 months has elapsed prior to disease progression.
Documentation of positive diagnosis for any of the following:\r\n* Non metastatic breast carcinoma following neo-adjuvant chemotherapy and appropriate surgery or following adjuvant radio/chemotherapy \r\n*Stage II or III colorectal adenocarcinoma following appropriate surgery and adjuvant chemotherapy or following appropriate neoadjuvant chemoradiation/surgery and adjuvant chemotherapy\r\n* Stage II bladder carcinoma following neo-adjuvant chemotherapy and appropriate surgery or following adjuvant chemotherapy; patients with recurrent tumors are not eligible\r\n** “Appropriate therapy” for each disease must be consistent with the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology
Subject is a candidate for chemotherapy in the adjuvant setting. Adjuvant therapy must begin within 84 days of the final surgical procedure for breast cancer.
No prior chemotherapy for gastric cancer except adjuvant and/or neo-adjuvant chemotherapy more than 12 months ago
Adjuvant chemotherapy more than 12 months prior to study enrollment.
Previous therapy for Stage IV NSCLC, or neo- or adjuvant chemotherapy or chemoradiotherapy within the previous 6 months
Adjuvant chemotherapy if relapse occurred at least 6 months after completion of adjuvant chemotherapy
At least 4 weeks since last adjuvant therapy or other cancer treatment
Received prior ipilimumab therapy (Prior Adjuvant Ipilimumab and Adjuvant Interferon are permitted with a minimum 4 week washout)
Prior 5-FU-based adjuvant chemotherapy less than 6 months prior to beginning ADAPT therapy and any residual neuropathy > grade 2
Adjuvant chemotherapy
Greater than 6 months since receiving neo-adjuvant or adjuvant chemotherapy
Less than 6 months since prior adjuvant chemotherapy.
Prior adjuvant therapy for current melanoma diagnosis;
For all subjects, prior post-operative adjuvant administration of anti-HER2 therapy is permissible.
Any prior chemotherapy, except short-course neo-adjuvant or adjuvant chemotherapy that had been stopped for at least 6 weeks prior to Study enrollment;
Adjuvant therapy < 6 months prior to study day 1.
Received no more than 1 prior chemotherapy regimen for advanced or metastatic disease (not including neo-adjuvant and/or adjuvant therapy) (Part 1)
relapsed while receiving adjuvant therapy with an AI or,
Patients may or may not have had adjuvant chemotherapy
Any previous chemotherapy for inoperable locally advanced or metastatic TNBC or HR+/HER2- adenocarcinoma of the breast (patients receiving neo/adjuvant chemotherapy eligible provided they have at least a 12 month disease-free interval)
Patients with potential diagnosis of ovarian, fallopian, or primary peritoneal cancer; care plan including surgical debulking and traditional adjuvant or neo-adjuvant chemotherapy (6-9 cycles of platinum and taxane based therapy)
Subjects who participated in therapeutic adjuvant ovarian cancer studies are excluded except for platinum-based adjuvant studies
The subject is a candidate for neo-adjuvant chemoradiation therapy
Prior non-adjuvant chemotherapy for any malignancy. Adjuvant chemotherapy for colorectal cancer is not an exclusion criteria provided that it was completed more than 6 months before entry into the study.
Must have completed at least 4 cycles of adjuvant/neo-adjuvant cytotoxic chemotherapy between 1 and 5 years prior to registration (ongoing herceptin or other chronic human epidermal growth factor receptor [HER] 2 directed therapies are allowed)
Patients must be deemed by their treating oncologist as candidates for (neo) adjuvant chemotherapy with dose dense doxorubicin, cyclophosphamide, and paclitaxel (ACT)
Neo-adjuvant systemic therapy
Planned to receive treatment with either adjuvant or neo-adjuvant taxane-based chemotherapy
Operable breast cancer\r\n* Patients who are planned to undergo neo-adjuvant chemotherapy are eligible as long as they consent to an additional breast biopsy following the dietary intervention immediately prior to starting chemotherapy
Treatment plan that includes neo-adjuvant radiation therapy followed by surgical resection
Treatment plan that doesn’t include neo-adjuvant radiation and surgical excision
No plan for adjuvant endometrial cancer therapy
4) Patients on adjuvant hormone therapy for less than 2 months.
Have completed primary treatment for their cancer; primary treatment will be defined as having completed all (a) definitive cancer surgery, (b) (neo)adjuvant chemotherapy, and/or (c) (neo)adjuvant radiation; breast cancer patients still receiving adjuvant endocrine or human epidermal growth factor receptor 2 (HER2) targeted therapies are eligible, as would colon cancer patients receiving a targeted agent; if there is any question whether a patient meets this eligibility requirement, Dr. Tevaarwerk (co-I, Oncology) will adjudicate
Planned primary or adjuvant chemoradiation therapy
BRAIN CANCER: Starting adjuvant temozolomide therapy
Planned (neo)adjuvant therapy with trastuzumab (Herceptin) plus chemotherapy
Completed neo-adjuvant or adjuvant chemotherapy
Currently take adjuvant AI therapy
> 6 months post local and/or adjuvant therapy
Scheduled to begin an appropriate adjuvant or neo-adjuvant chemotherapy regimen as defined by National Comprehensive Cancer Network (NCCN) guidelines (www.nccn.org); patients receiving anti-HER-2 therapy are eligible but the intervention will only be tested during the chemotherapy portion of the regimen
Have completed primary treatment defined as definitive surgery, (neo)adjuvant chemotherapy and/or (neo)adjuvant radiation; participants still receiving adjuvant endocrine or HER2 targeted therapies are eligible
Potential participants are women who have a diagnosis of invasive breast cancer (stage I-III) and are anticipated to start neo-adjuvant or adjuvant chemotherapy with an anthracycline and/or a taxane lasting 18-24 weeks with or without ovarian suppression
Women enrolled at Kansas University Medical Center (KUMC), should be willing to undergo brain magnetic resonance imaging (MRI) at baseline prior to starting neo-adjuvant or adjuvant chemotherapy, again just before starting the first dose of the last cycle of neo-adjuvant chemotherapy prior to scheduled surgery or 3 weeks after the last cycle of adjuvant chemotherapy, and ~6 months after completion of neo-adjuvant or adjuvant chemotherapy, unless one of the following circumstances apply: 1) claustrophobia, 2) medical contraindication, 3) metal implants, or 4) cannot be scheduled prior to scheduled start of neo-adjuvant or adjuvant chemotherapy; women will be screened by the study coordinator and staff at the Hoglund Brain Imaging Center for final eligibility to undergo fMRI (e.g., no metal implants, claustrophobia, medical contraindications); note that women declining an fMRI or in whom MRI cannot be scheduled prior to start of neo-adjuvant therapy will still be able to participate in the rest of the study but will not have a subsequent research related MRI
For patients not receiving adjuvant therapy, end of therapy will be defined as six months post diagnosis (patient)
Adjuvant treatment: laser or any surgical intervention
Women who are receiving, or scheduled to receive, one of the following classes of therapy in the adjuvant or neo-adjuvant setting: anthracyclines, taxanes, cyclophosphamide, or trastuzumab; participants must be within their first two rounds of chemotherapy
Has completed prior surgical management and adjuvant endometrial cancer treatment, if adjuvant treatment is indicated, prior to starting aim 1
Planned paclitaxel at a dose of 80 mg/m^2 intravenously (IV) given, in the adjuvant breast cancer (postoperative or neo-adjuvant) setting, every week for a planned course of 12 weeks without any other concurrent cytotoxic chemotherapy (trastuzumab and/or other antibody and/or small molecule treatment is allowed, except for PARP inhibitors)
Have had surgery, completed treatment within the last two years, or still receiving adjuvant therapies
In order to allow for time for central genotyping and eligibility for the ALCHEMIST treatment trial, patients must register within the following eligibility windows, depending on the adjuvant treatment approach:\r\n* If no adjuvant therapy, register patient within 75 days following surgery\r\n* If adjuvant chemotherapy or radiotherapy only, register patient within 225 days following surgery\r\n* If adjuvant chemotherapy and radiation, register patient within 285 days following surgery
Radiotherapy must begin within 12 weeks of the last breast cancer surgery or the last dose of adjuvant chemotherapy
Subjects who have either received chemotherapy for metastatic disease or are considered by the treating investigator to be appropriate candidates for chemotherapy as current treatment for metastatic breast cancer are excluded. Chemotherapy administered for adjuvant/neo adjuvant disease is acceptable provided it was administered at least 1 year prior to study entry.
Patients who received (neo)adjuvant therapy for breast cancer are eligible. Prior therapy with letrozole or anastrozole in the (neo)adjuvant setting is permitted if the disease-free interval is greater than 12 months from the completion of treatment.
Subject has undergone neo-adjuvant chemotherapy or neo-adjuvant endocrine therapy for current breast cancer
Participants may or may not have received (neo)adjuvant chemotherapy, but must be at least 30 days after last dose of chemotherapy and/or biological therapy, with no more than grade 1 residual toxicity at the time of screening
Patient scheduled to be receiving weekly adjuvant or neo-adjuvant paclitaxel for 12 weeks
Operable and necessitates adjuvant or neo-adjuvant treatment
Completed NCCN approved neo-adjuvant/adjuvant chemotherapy or both
Received any radiation or hormone therapy (neo-adjuvant, adjuvant, or salvage)
The patient must have completed adjuvant chemotherapy more than 6 months ago, but no more than 36 months prior to initial study scan
Neo-adjuvant hormonal therapy
Group D only: Patients who have received only one prior systemic therapy treatment consisting of a PD-1 and/or PD-L1 inhibitor with or without a CTLA4 inhibitor for NSCLC, with exception of neo-adjuvant or adjuvant therapy as depicted in inclusion criterion 4. The last dose of prior immunotherapy must have been administered at least 6 weeks prior to the start of study treatment (cycle 1 day 1).
Clinical need for adjuvant chemotherapy
Received any adjuvant chemotherapy
Prior history of cancer, neo-adjuvant chemotherapy and radiation therapy
Neo-adjuvant hormonal therapy
Previously treated with systemic therapies to treat the cancer to be removed during this clinical investigation, such as neo-adjuvant chemotherapy or hormonal therapy
any neo-adjuvant therapy
Subjects previously treated with systemic therapies to treat cancer, such as neo-adjuvant chemotherapy or hormonal therapy.
Subjects previously treated with systemic therapies to treat cancer, such as neo-adjuvant chemotherapy or hormonal therapy.
For Adjuvant Treatment: No prior treatment with BTZ, CFZ, or IXZ
Has been treated with (neo)adjuvant anthracycline, if they received systemic treatment in the (neo)adjuvant setting, unless anthracycline was contraindicated or not considered the best treatment option for the participant in the opinion of the treating physician.
Women more than 180 days out from primary breast surgery or adjuvant chemotherapy
Patients must not have received any chemotherapy within 14 days prior to registration
Patients with cervix cancer who have received any previous radiation or chemotherapy
Patients who have received any chemotherapy (excluding steroids) and/or RT prior to this enrollment
Patients who have received prior chemotherapy or radiation therapy are not eligible
Patients may have received prior hormone therapy and/or systemic chemotherapy; such therapy must have been completed at least 6 months prior to study entry and the patient has clear evidence of disease subsequent to such therapy; patients must not have received neoadjuvant chemotherapy for the present recurrent disease
Patients who received chemotherapy directed at the present recurrence
Patients who have received any previous chemotherapy or radiation therapy are not eligible
Patients must not have received any prior chemotherapy, radiation therapy, or other therapy for the treatment of ALL (other than those noted below) and must not be receiving any immunosuppressive therapy; patients may not have received any prior investigational therapy within 28 days prior to registration; patients must not have received any monoclonal antibody therapy within 42 days of registration; patients may have received the following within any time prior to registration: low dose chemotherapy-including: cyclophosphamide 1 g/m^2, oral 6-mercaptopurine, or oral methotrexate (other low dose chemotherapy may be allowable, however any other options not listed here should be confirmed with the study chairs), TKI therapy, steroids, hydroxyurea, leukapheresis, intrathecal chemotherapy or vincristine (vincristine sulfate)
Multiple myeloma: must have received prior chemotherapy; consolidation of chemotherapy by autografting prior to nonmyeloablative HCT is permitted
Patients who received chemotherapy (including monoclonal antibodies) or radiotherapy, administered for any condition, within 4 weeks prior to registration are not eligible
Patients must have received some immunosuppressive chemotherapy in the preceding 3 months.
Patients who have received prior radiation or chemotherapy may be enrolled on this study
Patients may not have received prior systemic treatment (chemotherapy or targeted therapy) for advanced BTC; prior adjuvant chemotherapy is permitted provided it was completed > 6 months from registration
Subject has received prior radiation therapy or chemotherapy for prostate cancer
Prior systemic chemotherapy or radiation therapy for transitional cell carcinoma of the bladder\r\n* Subjects who have received prior intravesical chemotherapy are allowed
Prior chemotherapy or tumor vaccine therapy or biological therapy for the treatment of melanoma. Subjects who received chemotherapy for the management of other malignancies are potentially eligible if the subject has not received chemotherapy in prior 5 years, remained disease free, and following discussion with and agreement by the principal investigator
Patients receiving concomitant chemotherapy administration in the 5 days preceding brachytherapy (except for gynecological cancer patients who may have received concurrent chemotherapy as a component of their treatment regimen)
Subjects must not have received chemotherapy within 2 weeks of planned first (1st) day of radiation therapy (RT)
Patients can have had any number of prior therapies, however must have had previous therapy with at least radiotherapy; patients with oligodendroglioma must have also received chemotherapy in addition to radiation therapy
Multiple myeloma – must have received prior chemotherapy; consolidation of chemotherapy by autografting prior to nonmyeloablative HCT is permitted
Patients can either be chemotherapy-naive or have received platinum-based chemotherapy for locally advanced or metastatic disease; acute effects of therapy must have resolved to baseline severity or to CTCAE grade =< 1 except for AEs that in the investigator’s judgment do not constitute a safety risk for the patient; patients who have received prior treatment with checkpoint inhibitors are eligible
STUDY TREATMENT: Patients must have received systemic radiosensitizing chemotherapy with definitive pelvic radiation therapy; patients may have received partial amount of chemotherapy and radiation (both) to be eligible
Patients must have received standard of care therapy with chemoradiation with temozolomide followed by adjuvant chemotherapy with temozolomide. Patients may have received one additional chemotherapy regimen (other than lomustine) in addition to adjuvant temozolomide prior to study entry (patients at either first or second recurrence are eligible).
Received more than 1 prior systemic chemotherapy in the unresectable or metastatic setting; if the patient received 1 prior systemic chemotherapy, the patient is eligible; having received prior therapies for breast cancer (such as everolimus or experimental agents) does not affect eligibility for this study
Patients must have a histologically confirmed solid tumor that is surgically resected and have completed all planned adjuvant therapy or are not planned for any adjuvant therapy (including hormonal); patients must have fully recovered from surgery (i.e. sutures and drains have been removed); patients must have recovered from toxicity of prior chemotherapy and/or radiotherapy; patients may not have received chemotherapy in the prior four weeks; patients may have not received radiotherapy in the prior three weeks
Patients who have received prior radiation or chemotherapy may be enrolled on this study
Patients must have not have received any prior therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) for the treatment of stage IV NSCLC; patients may have received prior adjuvant or neoadjuvant chemotherapy or chemotherapy given as part of a curative intent chemoradiotherapy approach for NSCLC, if the last administration of the prior regimens occurred at least 1 year prior to study entry
BC patients with a previous history of another cancer who have NOT received any chemotherapy or chemotherapy and radiation, but have only received surgical treatments are eligible;
Patients who have received prior chemotherapy
Patients who received previous anti-folate-containing chemotherapy
PRIOR TO LYMPHODEPLETION: Received chemotherapy within the previous 3 weeks prior to lymphodepletion
Patients may have received prior systemic chemotherapy; such therapy must have been completed at least 5 years prior to study entry and the patient has no evidence of disease subsequent to such therapy; patients must not have received neoadjuvant chemotherapy for the present disease
Patients who received chemotherapy directed at the present disease
Patients who have received chemotherapy and/or radiation therapy within 2 weeks unless there is evidence of rapidly progressive disease; in the event that subjects have received chemotherapy < 2 weeks from the date of enrollment, they may be included provided they have recovered from the associated non-hematological toxicities to less than or equal to grade 1; hydroxyurea is allowed up to 24 hours prior to starting therapy in the setting of rapidly proliferating disease
Patients must not have received any systemic chemotherapy for advanced biliary cancer
Subject has received chemotherapy within the last 4 weeks prior to first treatment.
Patients who have received prior chemotherapy for endometrial cancer.
Has not received chemotherapy in the last 28 days
Patients who have received systemic chemotherapy or radiotherapy within two months prior to first scheduled cycle of postoperative chemotherapy
Patients must have received prior induction chemotherapy for at least 2 months and up to 6 months; at least three weeks should have elapsed after the last chemotherapy
Any prior adjuvant cytotoxic chemotherapy within 12 months of registration; subjects who received chemotherapy for earlier stage disease more than 12 months prior to study registration are eligible for this trial
Patients must not have received systemic chemotherapy for at least 4 weeks, and must not have received prior radiation therapy to the tumor site being irradiated on this study
Patients who have received prior chemotherapy (including Gliadel wafers) for the current glioma
Patients who have not completed standard of care treatment prior to participation in this trial, i.e. surgical procedure and radiation therapy (at least 59 Gy); Note: If tumor is unmethylated, patients are not mandated to have received chemotherapy prior to participation in this trial; however, if tumor is methylated, patients must have received at least one chemotherapy regimen prior to participation in this trial
Patients who have received prior chemotherapy
If a cancer survivor, the patient received prior systemic chemotherapy or radiotherapy
Subjects who have received chemotherapy within 12 months prior to randomization
Either:\r\n* Patients who have received radiation therapy (RT): Previously (>= 6 months before to enrollment) completed treatment for pancreatic or periampullary adenocarcinoma consisting of either surgical resection with neoadjuvant/adjuvant conventional conformal radiation therapy (CRT) for resectable disease or conventional CRT as definitive treatment for unresectable disease; these patients who have received prior radiation therapy will constitute Cohort A and will receive SBRT as 5 Gy x 5; patients may be receiving continued chemotherapy post initial CRT; OR\r\n* Patients who have not received RT: Previously (>= 3 months before retreatment) initiated treatment for pancreatic or periampullary adenocarcinoma consisting of chemotherapy alone for unresectable disease or surgical resection with neoadjuvant/adjuvant chemotherapy for resectable disease; these patients who have not received prior radiation therapy will constitute Cohort B and will receive SBRT as 6.6 Gy x 5; patients must have attempted chemotherapy upon initial diagnosis
Patients with cervix cancer who have received any previous radiation or chemotherapy
Patients enrolled in Strata A and B may not have received any prior chemotherapy or anti-glioma therapy of any type other than radiation therapy; patients enrolled on Stratum C must have received at least two prior chemotherapy or biologic therapy regimens and may not have received radiation to the index lesion within 1 year of enrollment; patients on Strata A, B, E, and F cannot have received chemotherapy after radiation therapy was completed
Patients may have received prior chemotherapy
Stage I: subjects may have already received no more than 2 cycle of their platinum-based chemotherapy but should not have received other prior chemotherapy regimens with the exception of patients with metastatic disease who received neoadjuvant or adjuvant chemotherapy and that chemotherapy was completed > 6 months prior to enrollment
Multiple myeloma: Must have received prior chemotherapy; consolidation of chemotherapy by autografting prior to nonmyeloablative hematopoietic cell transplant (HCT) is permitted
Patients must not have received any other anti-cancer treatment (including surgery, radiation or systemic chemotherapy) since the base trial.
Patients who have received standard chemotherapy with FDA approved agents within 21 days of entry into the protocol.
Received chemotherapy drugs within previous 2 weeks
Participants who have received any chemotherapy or radiotherapy for previous malignancy are not eligible
Patients are not eligible who have received systemic chemotherapy or investigational agents =< 28 days prior to registration
Patients must have received prior treatment with chemotherapy. Chemotherapy may have previously been given with a PD-1 or PDL-1 inhibitor.
Patients who have received previous chemotherapy or radiation therapy (does NOT include steroids)
Patients must not have received prior chemotherapy, radiotherapy, or antibody therapy for lymphoma
Patients may have received no prior chemotherapy for stage IV disease; patients may have received prior adjuvant therapy (chemotherapy and/or chemoradiation) if more than 6 months have elapsed between the end of adjuvant therapy and registration
Patients who have received any radiotherapy or chemotherapy for their current gynecological cancer
Patients must NOT have received prior chemotherapy or targeted therapy, including chemotherapy used for radiation sensitization for treatment of endometrial carcinoma
Patient has received systemic chemotherapy =< 3 weeks prior to registration
Patients in the relapsed/refractory AML cohort (Cohort 2), must meet all of the following criteria:\r\n* Patient must have received at least one prior Induction chemotherapy regimen for their AML;\r\n** They may have received any type of chemotherapy\r\n** Administration of hydroxyurea to control high white blood cells (WBC) prior to, during, and after registration is permitted\r\n* Relapse or refractory disease must be documented by a bone marrow examination demonstrating > 5% blasts in the bone marrow not attributable to another cause\r\n* Patient must NOT have received chemotherapy within 14 days prior to registration
Subject must have received at least 6 months of chemotherapy
Patients who received prior systemic chemotherapy for the study cancer.
Patients on the Phase I portion may not have received ANY prior chemotherapy; patients on the Phase II portion may have received one prior cycle of any non-investigational chemotherapy; prior chemotherapy must have been completed within 56 days prior to registration and all toxicities must have resolved to =< grade 1; patients on either portion may have received prior treatment with dexamethasone, providing total number of days of treatment was =< 14 days and total treatment dose was =< 360 mg
Have received previous chemotherapy for advanced NSCLC. Participants who have received adjuvant or neoadjuvant chemotherapy are eligible if the last administration of the prior regimens occurred at least 1 year prior to study entry.
Subjects who have received any systemic chemotherapy, including anti-VEGF therapy, or any systemic investigational anticancer agents, including lenvatinib, for advanced/unresectable HCC. Note: Subjects who have received local hepatic injection chemotherapy are eligible.
Patients may not have received more than one prior chemotherapy
Patients who have received any prior chemotherapy are not eligible
May not have received prior chemotherapy; if patient has received prior adjuvant therapy, must be > 6 months from treatment
Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded; patients who have received neoadjuvant chemotherapy prior to their initial debulking are excluded; patients may have received prior adjuvant chemotherapy for breast cancer
Patients who have received prior chemotherapy (including Gliadel wafers) for the current glioma
Patients who received chemotherapy directed at the present disease
Patients who have received previous chemotherapy or radiation therapy to treat the current disease
Currently receiving any chemotherapy, investigational agents or registration on another therapy based trial or received chemotherapy with radiation therapy (e.g., temozolomide)
Patients who have received prior radiation or chemotherapy may be enrolled on this study
Patients who received investigational chemotherapy prior to radiation therapy are excluded from this study
Patients who have received prior treatment with implanted radiotherapy or chemotherapy sources such as wafers of polifeprosan 20 with carmustine
Subject may have received chemotherapy or other therapy after harvest of tumor and prior to enrollment; subjects who have achieved complete response following chemotherapy are still eligible for participation
Patients may have received no prior chemotherapy for stage IV disease; patients may have received prior adjuvant therapy (chemotherapy and/or chemoradiation) if more than 6 months have elapsed between the end of adjuvant therapy and registration
Patients who have received prior chemotherapy for their original breast cancer treatment are still eligible
Multiple myeloma or plasma cell leukemia must have received more than one line of prior chemotherapy; consolidation of chemotherapy by autografting prior to nonmyeloablative HCT is permitted
Patients may have received no prior chemotherapy for metastatic or unresectable disease; patients may have received prior adjuvant therapy (chemotherapy and/or chemoradiation) if more than 6 months have elapsed between the end of adjuvant therapy and registration; patients may not have received prior docetaxel or cisplatin
Prior chemotherapy, radiation for any malignancy in which they received any thoracic radiotherapy
5. Received last dose of prior chemotherapy within ? 6 weeks of first dose of VS-6063.
Patients who have received chemotherapy within 7 days prior to the cryoablation procedure
Patient must not have received prior chemotherapy or radiation for pancreatic cancer and no exposure to systemic chemotherapy
Patients must have completed at least 1 prior line of chemotherapy for germ cell tumor (except patients who present with primary pure teratoma who need not have received any previous chemotherapy)
For patients who received prior adjuvant chemotherapy or chemoradiotherapy: a treatment-free interval of at least 12 months since last chemotherapy or chemoradiotherapy cycle
Patients must be pemetrexed-naïve; patients may have received any number of prior chemotherapy or molecularly targeted agents; if crizotinib was used in the first (1st) line setting then chemotherapy naive patients are also eligible; if patient received crizotinib in combination with chemotherapy, prior chemotherapy must have been discontinued at least 14 days prior to registration and all adverse events must have resolved to =< grade 1
Prior chemotherapy is allowed if >= one month from the end of treatment; patients must not have received chemotherapy within 4 weeks of the start of study drug
Received radiotherapy and temozolomide chemotherapy
All patients must have received at least one standard chemotherapy or chemoradiotherapy
Has received previous chemotherapy for Stage IV NSCLC (participants who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 6 months prior to randomization)
Prior systemic chemotherapy for transitional cell carcinoma of the bladder; subjects who have received prior intravesical chemotherapy are allowed if completed 28 days prior to cycle 1 day
Patients may have received one prior chemotherapy regimen for recurrence or progression; cisplatinum with concurrent radiation does not count as a prior chemotherapy; prior treatment with bevacizumab is allowable
Have received cancer treatment that includes chemotherapy for at least 2 months
Patients may have received any of the following therapies: surgery, chemotherapy, hormones, biologics, or radiation
Received previous chemotherapy
Subject has received chemotherapy within the past 2 weeks
Having received chemotherapy with or without radiation therapy
Subject has received chemotherapy, radiotherapy or surgery for the treatment of breast cancer
Have received radiation therapy or chemotherapy for any condition other than primary HNC
Patient must not have received chemotherapy within 3 weeks of initiation of PCI
Patients may have previously received other chemotherapy
Cancer diagnosis or received treatment (chemotherapy or radiotherapy) for malignancy within the previous 6 months
Multiple myeloma – must have received prior chemotherapy; consolidation of chemotherapy by autografting prior to nonmyeloablative HCT is permitted
Received chemotherapy for treatment of childhood cancer
Patient has received prior chemotherapy or radiotherapy for this cancer
Patients who have received any prior therapy for prostate cancer with surgery, radiation, and/or chemotherapy
Patients must not have received prior chemotherapy or radiation for >= 2 weeks before study enrollment
Patients who have received more than one previous therapy regimen (radiation or chemotherapy) are not eligible for this study
Patient has received chemotherapy for any type of cancer within 90 days from date of screening CDU;
At the time of enrollment, patients may not have received any biological, chemotherapy, or radiation therapy
Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded; patients who have received neoadjuvant chemotherapy prior to their initial debulking are excluded; patients may have received prior adjuvant chemotherapy for breast cancer
Must not have received prior radiation therapy or chemotherapy for this diagnosis
Patients who have received previous treatment (chemotherapy or radiotherapy) for any brain tumor (primary or metastatic)
Patients may not have received prior chemotherapy or radiation therapy for lung cancer
Patient has received prior chemotherapy or radiotherapy for this cancer
Must have received at least 1 prior approved immunotherapy or chemotherapy; however, not within 28 days of the initial dose of study drug. May have received prior radiotherapy for their malignancy.
For Cohort E only: prior treatment with fulvestrant is prohibited
Fulvestrant within 30 days prior to first dose of study drug.
For Part G (abemaciclib + LY3023414 + fulvestrant): The participant may have received prior systemic endocrine therapy with at least one nonsteroidal aromatase inhibitor (anastrozole, letrozole) for metastatic disease.
Cohort 5: Prior treatment with fulvestrant; Prior treatment with chemotherapy for advanced/metastatic disease; Any line(s) of therapy following treatment failure with a CDK 4/6 inhibitor in combination with an AI; Prior treatment with chemotherapy in the advanced/metastatic setting or with fulvestrant; Advanced/metastatic disease that is symptomatic and/or with visceral spread
Fulvestrant combination cohort (F): MBC with progression who are candidates for a fulvestrant containing regimen, with palbociclib.
Prior selective estrogen receptor downregulator use (SERD), including fulvestrant
Candidate for fulvestrant therapy – patients who have started fulvestrant may enter this trial if within 3 months of starting fulvestrant
Known abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants precluding intramuscular injections of fulvestrant or goserelin (if applicable)
Any condition contraindicating fulvestrant administration:
Patients must have been treated with fulvestrant for at least 56 days as their most current anti-cancer treatment, and they must be tolerating fulvestrant with at most grade I toxicity by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Known abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants precluding intramuscular injections of fulvestrant or goserelin (if applicable).
patient has known hypersensitivity to alpelisib, fulvestrant or letrozole
ADDITIONAL INCLUSION CRITERIA FOR PATIENTS IN COMBINATION FULVESTRANT/CABOZANTINIB COHORT
ADDITIONAL EXCLUSION CRITERIA FOR PATIENTS IN COMBINATION FULVESTRANT/CABOZANTINIB COHORT
Subject has had prior progression on treatment with fulvestrant (prior adjuvant treatment or brief exposure in the advanced setting is allowed)
may have received any endocrine therapy (excluding fulvestrant)
At least 6 months must have elapsed from the use of fulvestrant
Inclusion Criteria:\n\n        Phase 1a portion\n\n          -  Histologically or cytologically proven diagnosis of adenocarcinoma of the breast with\n             evidence of either locally recurrent disease not amenable to resection or radiation\n             therapy with curative intent, or metastatic disease, both progressing after at least 6\n             months of hormonal therapy for estrogen receptor (ER) positive breast cancer\n\n          -  ER-positive, human epidermal growth factor 2 (HER2) negative\n\n          -  At least 2 months must have elapsed from the use of tamoxifen\n\n          -  At least 6 months must have elapsed from the use of fulvestrant\n\n          -  At least 2 weeks must have elapsed from the use of any other anticancer hormonal\n             therapy\n\n          -  At least 3 weeks must have elapsed from the use of any chemotherapy\n\n          -  Postmenopausal status\n\n          -  Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2\n\n          -  Adequate organ function\n\n        Phase Ib portion\n\n          -  All above inclusion criteria, except:\n\n          -  Postmenopausal status, pre- and peri-menopausal participants will also be included\n\n          -  ECOG performance status less than 2\n\n          -  At least 2 months must have elapsed from the use of tamoxifen not applicable\n\n          -  At least 6 months must have elapsed from the use of fulvestrant not applicable\n\n        and plus:\n\n          -  Documented sensitivity to prior hormonal therapy\n\n          -  Cohort C1 (palbociclib combination cohorts): no prior treatment with cyclin-dependent\n             kinase (CDK) 4/6 inhibitor\n\n        Phase IIa portion\n\n          -  All above inclusion criteria for Phase Ia, except:\n\n          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n\n          -  At least 6 months must have elapsed from the use of fulvestrant not applicable\n\n        and plus:\n\n          -  Cohort A only: confirmed estrogen receptor alpha (ESR1) mutation and presence of\n             measurable disease as per RECIST v1.1 or evaluable bone disease\n\n          -  Cohort A1 only: no prior fulvestrant allowed; at least 2 months must have elapsed from\n             the use of tamoxifen\n\n          -  Cohort A2 only: prior fulvestrant allowed\n\n          -  Cohort B only: disease progression following no more than 1 prior treatment with an\n             aromatase inhibitor in the advanced/metastatic setting\n\n          -  Cohort B1 only: no prior fulvestrant allowed\n\n          -  Cohort B2 only: prior fulvestrant allowed\n\n        Exclusion Criteria:\n\n        Phase 1a portion\n\n          -  Untreated or symptomatic central nervous system (CNS) metastases\n\n          -  Endometrial disorders\n\n          -  More than 2 prior chemotherapy in the advanced/metastatic setting (prior adjuvant\n             chemotherapy is allowed so long as it occurred greater than or equal to 12 months\n             prior to enrollment)\n\n          -  Current treatment with any systemic anticancer therapies for advanced disease\n\n          -  Any significant cardiac dysfunction within 12 months prior to enrollment\n\n          -  Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or upper\n             gastrointestinal surgery including gastric resection\n\n          -  Known human immunodeficiency virus (HIV) infection\n\n          -  Known clinically significant history of liver disease\n\n          -  Major surgery within 4 weeks prior to enrollment\n\n          -  Radiation therapy within 2 weeks prior to enrollment\n\n        Phase Ib portion - all above exclusion criteria, plus:\n\n          -  Cohort C1 (palbociclib combination cohorts): history of venous thromboembolic event\n             requiring therapeutic anticoagulation; vaginal bleeding within 2 months prior to\n             enrollment\n\n        Phase IIa portion - all above exclusion criteria, plus:\n\n          -  Cohort A1, A2, and Cohort B2 only: more than 1 prior chemotherapy in the\n             advanced/metastatic setting\n\n          -  Cohort B1 only: prior chemotherapy in the advanced/metastatic setting
Participants for whom endocrine therapy (example [e.g.], fulvestrant) is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study
Prior treatment with fulvestrant
Part A, B and C: Fulvestrant therapy less than 90 days before first dose of study treatment. Part D: Fulvestrant therapy less than 42 days before first dose of study treatment
Therapeutic-dose anticoagulation must be discontinued and coagulation parameters must be normalized prior to the first dose of GSK525762 and fulvestrant.
Prior treatment with fulvestrant
Subject has received prior treatment with fulvestrant.
Prior treatment with eribulin, fulvestrant or anastrozole, paclitaxel, abraxane, docetaxel, vinorelbine, or capecitabine
Participants who have received previous therapy with neratinib or fulvestrant
Prior treatment with fulvestrant
Patients who have received other agents that modulate or downregulate the estrogen receptor (e.g. raloxifene, fulvestrant) in the locally advanced or metastatic setting are eligible if they were on treatment for at least 6 months and must have discontinued these agents 6 months prior to study registration
Disease refractory to either, AI, tamoxifen or fulvestrant
Patients in the combination arms - known hypersensitivity to fulvestrant
patient had been permanently discontinued from oral dovitinib study treatment, either alone or in combination with fulvestrant, in the parent study
Received one prior cycle of fulvestrant within 28 days of randomization are eligible.
?2 prior doses of fulvestrant are not eligible
Hyper sensitivity to fulvestrant treatment excipients
Previous treatment with fulvestrant
As per national or local treatment guidelines, endocrine therapy (i.e., fulvestrant) is recommended and treatment with cytotoxic chemotherapy is not necessary for participants, at time of entry into the study.
They have progressed on at least one previous line of endocrine therapy (ET) for\n                  their metastatic disease (but are not currently progressing on fulvestrant), OR;
Patients who are progressing on current fulvestrant therapy (patients who have had\n             fulvestrant therapy in the past and were subsequently treated with other therapies or\n             those who are starting fulvestrant as their next line of ET are eligible for the\n             study).
Patients must not be planning to receive concomitantly other biologic therapy, hormonal therapy, other chemotherapy, surgery or other anti-cancer therapy except radiation therapy while receiving treatment on this protocol; however, patients receiving extended adjuvant endocrine therapy for an earlier ER positive breast cancer treated with curative intent and without recurrence for at least 5 years may continue with their endocrine therapy
Patients who already received neo/adjuvant endocrine therapy are eligible as long as they are enrolled within 12 months of initial histological diagnosis and after completing no more than 6 months of adjuvant endocrine therapy.
Patients who previously received endocrine therapy within 5 years prior to diagnosis of the current malignancy.
Patients who have had any prior chemotherapy, or endocrine therapy for the treatment of breast cancer or any other cancer
Subjects with endocrine AE of any grade are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.
No prior chemotherapy or targeted systemic therapy (including endocrine therapy) for inoperable locally advanced or metastatic TNBC
Prior neoadjuvant chemotherapy, endocrine therapy, or biologic therapy for current breast cancer [Period 2]
For Part A (LY2835219 + letrozole): Except for ongoing therapy with letrozole, the participant must not have received prior systemic endocrine therapy for metastatic disease.
For Part B (LY2835219 + anastrozole): Except for ongoing therapy with anastrozole, the participant must not have received prior systemic endocrine therapy for metastatic disease.
For Part D (LY2835219 + exemestane): The participant must have received prior systemic endocrine therapy with at least one nonsteroidal aromatase inhibitor (anastrozole, letrozole) for metastatic disease and may be receiving ongoing therapy with exemestane.
ENDOCRINE RESISTANT COHORT: Pre-registration is not required for patients to be enrolled in the endocrine resistant cohort, as PIK3CA mutation status will not be assessed
ENDOCRINE RESISTANT AND ADJUVANT COHORT: Platelets >= 100,000/mcL
ENDOCRINE RESISTANT COHORT: Ki67 > 10% by central testing at Washington University AMP laboratory from a tumor biopsy performed after at least 2 weeks on neoadjuvant endocrine therapy; if Ki67 is > 10% by local testing, the Ki67 slide and H&E slide need to be reviewed by the study pathologist to confirm eligibility (discuss with study chair); for patients external to Washington University, please contact the Washington University coordinator by email so that a screening identification (ID)# can be assigned prior to shipment of the slides\r\n* Note that prior neoadjuvant endocrine therapy could include any endocrine therapy (including aromatase inhibitor, tamoxifen, fulvestrant) alone or in combination, or endocrine therapy in combination with any investigational agent that is not a Cdk 4/6 inhibitor\r\n* Patients who had a day 17 Ki67 > 10% from the NCI9170 trial are eligible for the endocrine resistant cohort\r\n* Note that enrollment to the endocrine resistant cohort will depend on the funding availability; please contact the study chair before enrolling patients to this cohort
ENDOCRINE RESISTANT COHORT: Prior treatment of this cancer including:\r\n* Surgery\r\n* Radiation therapy\r\n* Chemotherapy
No washout is required for endocrine therapy; if a patient has been on endocrine therapy within 28 days of study entry, that same endocrine therapy is permitted to be continued during protocol therapy, at the investigator’s discretion, as is continuation of ovarian suppression in premenopausal women; starting a new endocrine therapy during protocol therapy is not permitted
Prior systemic therapy:\r\n* Participant must be at least 14 days from the last dose of prior chemotherapy, endocrine therapy, biological agents (including small molecule targeted therapy) or any investigational drug product with adequate recovery of toxicity to baseline, or grade 1 (with the exception of alopecia and hot flashes) at the time of registration\r\n* There is no limit to the number of prior lines of therapy, including endocrine or cytotoxic agents; systemic treatment naive patients for metastatic disease are also eligible\r\n* Participants may initiate or continue bisphosphonate therapy on study\r\n* Continuation of ovarian suppression is allowed
Completed all adjuvant therapy including (if indicated) endocrine, trastuzumab, radiation therapy
Has received chemotherapy, immunotherapy, biologic therapy or endocrine therapy within the past 12 weeks
Has received no more than 5 previous lines of chemotherapy and has received at least one line of therapy with an endocrine therapy or endocrine therapy combination.
Women with non-metastatic breast cancer with any hormone receptor and Her 2 neu status who have completed surgery, chemotherapy, and radiation and are currently on endocrine therapy, single agent Herceptin, or observation
Prior cancer therapy (except for endocrine therapy) must have been discontinued for 1 week prior to initiation of study drugs
Patients with ER+ breast cancer must have progressed on at least 2 lines of endocrine therapy
For estrogen receptor (ER)-positive breast cancer, patients must be considered refractory to endocrine therapy, having received and progressed through at least one prior line of endocrine therapy, or are intolerant of endocrine therapy
Has received therapy for this current diagnosis of breast cancer including endocrine therapy or chemotherapy
Concurrent adjuvant endocrine therapy and bone-modifying agents is allowed
Patients must have completed at least 2 months of their current endocrine therapy prior to registration
More than two prior endocrine therapy regimens for the treatment of metastatic ER+ breast cancer
Patient must agree to the required research biopsies at baseline and after the two-week treatment with endocrine therapy in the initial part of the study (“window phase”); or at baseline and after two-week treated with endocrine therapy plus or minus palbociclib for those patients enrolled directly into the treatment phase of the study
Participants with endometrioid histology and histologically confirmed expression of estrogen receptors (ER) and/or progesterone receptors (PgR) who have not received prior endocrine therapy and for whom endocrine therapy is currently indicated.
Breast cancer treatment for the currently diagnosed breast cancer including radiation therapy, chemotherapy, targeted therapy, or endocrine therapy prior to study registration
Have received 0-2 lines of cytotoxic chemotherapy for metastatic breast cancer; prior endocrine therapy and/or targeted therapy is allowed
The subject must be deemed appropriate for neoadjuvant endocrine therapy by the referring medical oncologist
Patients must have been treated with at least one prior chemotherapy regimen in the metastatic setting or within 12 months of their last adjuvant systemic treatment and must be felt to be chemotherapy refractory; patients with ER positive disease must have demonstrated to be clinically endocrine-insensitive by progressing through at least one line of endocrine therapy, including approved combinations and considered candidate for more aggressive therapies (e.g. chemotherapy) per principal investigator (PI) or treating physician
Candidate for neoadjuvant endocrine therapy
Platelets >= 100,000/uL obtained no more than 28 days prior to the start of neoadjuvant endocrine therapy
Unwilling to undergo anti-endocrine therapy
Patient agrees to receive a 5 year minimum course of endocrine therapy following cryoablation for control of systemic disease
Diagnosis of stage 0-III breast cancer within 12 years prior to enrollment; all indicated surgery, chemotherapy, and/or radiation therapy must have been completed at least 12 weeks prior to enrollment; concomitant endocrine therapy and targeted therapies such as palbociclib, pertuzumab, and trastuzumab are permitted
For HR+ breast cancer participants in part A, B, C, and F: If currently receiving endocrine therapy, a participant may continue to receive the same endocrine therapy provided that extracranial disease is stable for at least 3 months and central nervous system (CNS) disease progression has occurred while on this endocrine therapy. If these conditions are not met, participants must discontinue endocrine therapy prior to initiation of abemaciclib.
Patients receiving cytotoxic therapy (including endocrine and biological agents), radiation therapy, immunotherapy or non-topical steroids, within three (3) to four (4) weeks of enrollment.
Prior treatment with less than 4 prior endocrine therapies for metastatic breast cancer
Last dose of chemotherapy must be at least 3 weeks before first dose of study treatment; there is no required washout for endocrine therapy
Eligible for and willing to undergo a course of adjuvant endocrine therapy
No limitations to number of prior chemotherapies for metastatic disease; treatment with prior taxanes (except nab-paclitaxel) is allowed as long as it has been 6 months or more since exposure to prior taxane; NOTE: For subjects who are, or who have previously received endocrine therapy for breast cancer, the treating investigator will decide how many days should pass between the last dose of endocrine therapy and the first dose of study treatment
Subjects should be > 2 weeks from prior systemic chemotherapy for breast cancer AND should have recovered to grade 1 or better (except alopecia) from related side effects of any prior antineoplastic therapy prior to study entry; NOTE: For subjects who are, or who have previously received endocrine therapy for breast cancer, the treating investigator will decide how many days should pass between the last dose of endocrine therapy and the first dose of study treatment
Treatment including radiation therapy (RT), chemotherapy, targeted therapy, or endocrine therapy for the currently diagnosed breast cancer prior to randomization
Patients must have had progressive disease after at least one line of endocrine therapy for metastatic disease (includes relapse while receiving endocrine therapy); there should be at least 1 week interval between the last endocrine treatment for an aromatase inhibitor and at least 2 weeks for tamoxifen or fulvestrant
Patients must not have begun chemotherapy or endocrine therapy for their breast cancer prior to registration
Step 2 Registration must take place within 84 days after definitive surgery; patients must not have begun chemotherapy or endocrine therapy for their breast cancer prior to randomization
There is no upper limit on prior chemotherapy, targeted therapy, or endocrine therapy
relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine therapy and then subsequently; progressed with documented evidence of progression while on or after only one line of endocrine therapy for metastatic disease;
Phase I (Cohorts J through S): Post-menopausal females with HER2-negative, hormone-receptor positive breast cancer that has progressed or failed to response to at least one prior endocrine therapy in the adjuvant or metastatic setting
Oral endocrine therapy </= 2 weeks before study treatment
Patient must have been previously treated with an aromatase inhibitor (either letrozole, anastrozole or exemestane) either in the adjuvant or metastatic setting, and have one of the following types of primary or secondary endocrine resistant disease\r\n* Primary clinical resistance is defined as one of the following:\r\n** Recurrence within the first 2 years of adjuvant endocrine therapy while on aromatase inhibitor therapy\r\n** Progression within first 6 months of initiating first-line endocrine therapy (either aromatase inhibitor or fulvestrant containing regimen) for the treatment of metastatic breast cancer \r\n* Secondary clinical resistance is defined as one of the following:\r\n** Recurrence after year 2 while receiving adjuvant aromatase inhibitor therapy, or within 12 months of completing adjuvant aromatase inhibitor therapy\r\n** Progression occurring 6 or more months after initiating the first endocrine therapy for metastatic disease (either fulvestrant or aromatase inhibitor containing regimen)
Previous adjuvant endocrine therapy for initial breast cancer was allowed but had to be discontinued at least 1 week before receiving the study drug
relapsed with documented evidence of relapse more than 12 months from completion of adjuvant endocrine therapy and then subsequently progressed with documented evidence of progression after one line of endocrine therapy (with either an antiestrogen or an aromatase inhibitor) for advanced/metastatic disease
Part A, B, C: Patients must have received no more than 2 prior chemotherapeutic regimens and at least 6 months of prior endocrine therapy
Part D: Patients may have received up to 1 previous line of chemotherapy and must have previously received 2 or more lines of endocrine therapy for advanced/metastatic breast cancer as a single agent or in combination. Patients must have received fulvestrant as one of the previous lines of endocrine therapy and have had documented progression while on, or within 1 month after the end of, fulvestrant therapy for advanced/metastatic breast cancer. Patients must have received prior treatment with a CDK4/6 inhibitor
Any other anti-cancer endocrine therapy less than 14 days before first dose of study treatment
No treatment for current primary invasive adenocarcinoma of the breast such as irradiation, chemotherapy, immunotherapy, investigational therapy or surgery; previous treatment for breast and/or ovarian cancer with chemotherapy, endocrine therapy, surgery and radiation are allowed if >= 3 years prior to current diagnosis and there is no clinical evidence of metastatic disease
Are currently receiving or have previously received endocrine therapy for locoregionally recurrent or metastatic breast cancer
Progressed within 12 months from prior adjuvant or progressed within 1 month from prior advanced/metastatic endocrine breast cancer therapy
Prior treatment for breast cancer with endocrine therapy (adjuvant or metastatic settings) is allowed but should be discontinued at randomization. Patients treated with bisphosphonates at entry or who start bisphosphonates during study may continue this therapy during protocol treatment.
Uncontrolled endocrine disorder. Patients who are on endocrine replacement therapy must be on a stable dose.
Relapsed or progressed following endocrine therapy.
Participants for whom endocrine therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study
Endocrine resistant breast cancer, defined as either:\r\n* Relapsed while on adjuvant endocrine therapy or within 1 year of completion of adjuvant endocrine therapy or\r\n* Progression through at least one line of endocrine therapy for metastatic or locally advanced breast cancer; there is no limit on the number of prior endocrine therapies received
Prior endocrine therapy for breast cancer.
relapsed with radiologic evidence of progression while receiving neoadjuvant or adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression
relapsed with radiologic evidence of progression within 1 year from completion of adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression
relapsed with radiologic evidence of progression more than 1 year from completion of adjuvant endocrine therapy and then subsequently relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first-line endocrine therapy for metastatic disease. Participants may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease
presented de novo with metastatic disease and then relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first line endocrine therapy for metastatic disease. Participants may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease
Participants must have demonstrated ability to tolerate adjuvant endocrine therapy, either tamoxifen or aromatase inhibitor (AI), by prior successful completion of at least 1 month of endocrine therapy without significant adverse events, and in the opinion of the treating physician any ongoing toxicity does not preclude ability to continue on endocrine therapy for at least a projected 2 year continuous duration; ongoing use of any AI, including letrozole, anastrozole, or exemestane, or tamoxifen is allowed; concurrent gonadotropin-releasing hormone (GNRH) agonist is allowable as well; patients may enroll within 2 years of beginning endocrine therapy, as long as there is a plan for at least 2 more years of adjuvant endocrine therapy
ER/PR breast cancer positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy.
Patients on bisphosphonates and/or endocrine therapy are eligible
Patients must have been diagnosed with the current breast cancer >= 3 and =< 60 months from planned baseline visit date; in addition, participants must have completed local therapy (i.e. surgery and radiation therapy) and any planned preoperative or adjuvant chemotherapy within >= 3 months prior to registration; NOTE: concurrent anti-human epidermal growth factor receptor 2 (HER2) therapy is permitted; concurrent endocrine breast cancer therapy is permitted; patients may enroll >= 3 months after initiation of hormone therapy and if expected to continue the same endocrine/hormone agent for the duration of the study (i.e., care should be taken to ensure a participant enrolling near 5 years since time of hormone treatment initiation will continue the same agent for at least 12 months, switching hormone therapy on study should be avoided); concurrent enrollment in other interventional or drug clinical trials is at the discretion of the protocol chair
Any number of prior endocrine therapies (including tamoxifen, fulvestrant and/or aromatase inhibitors in either the adjuvant or metastatic setting) and any number of prior chemotherapy regiments; anti-cancer systemic therapy, such as chemotherapy or biologics or endocrine therapy, other than the AI, must be discontinued for >= 3 weeks prior to starting study treatment
No limit on prior lines of endocrine therapy or biologic therapy; endocrine therapy and biologic therapy must be discontinued at least 7 days prior to initiation of protocol therapy
Breast cancer patients must be at least 3 months post-active treatment (including chemotherapy, radiation therapy, endocrine therapy, and/or maintenance therapy), but not greater than 5 years post-active treatment (exception: aromatase inhibitors (AIs) are required, and monoclonal antibodies are allowed)
Endocrine resistant breast cancer, defined as either:\r\n* Relapsed while on adjuvant endocrine therapy or within 1 year of completion of adjuvant endocrine therapy or\r\n* Progression through at least one line of endocrine therapy for metastatic or locally advanced breast cancer; there is no limit on the number of prior endocrine therapies received
Receiving concurrent endocrine, cytotoxic, or biologic agent(s) or within time limits specified above prior to study day 1
If the participant is currently receiving or initiating standard adjuvant endocrine therapy at time of study entry, she/he must not have received more than 12 weeks of adjuvant endocrine therapy following his/her last non-endocrine therapy (surgery, chemotherapy, or radiation).
Subjects must be receiving or be scheduled to receive standard of care systemic adjuvant or neoadjuvant chemotherapy and/or endocrine therapy and/or HER-2 targeted therapy
Prior endocrine therapy for any histologically-confirmed cancer is not allowed; prior endocrine therapy that was administered >= 5 years ago for the prevention of breast cancer in patients with no history of breast cancer is allowed
There is no limit to the number of prior chemotherapy or endocrine therapy regimens allowed; patients with ER(+) AR(+) breast cancer must have had at least 1 prior line of endocrine therapy to be eligible for the phase I portion of the trial
Neoadjuvant endocrine monotherapy is deemed to be a suitable therapy.
Patients with metastatic disease currently on endocrine therapy must be willing to stop endocrine therapy for 2 weeks prior to starting the study and to switch to a new endocrine therapy on the study (at week 4)
Can be on other endocrine therapy if willing to change a different endocrine therapy agent for the trial
Must have at least one FDA approved endocrine therapy option with which the patient has not received prior treatment
Patients must have had endocrine therapy initiated or planned for >= 5 years; endocrine therapy can be given concurrently or following RT
Patients treated with neoadjuvant chemo or endocrine therapy for breast cancer
Participants with HR+/HER2- breast cancer for whom endocrine-based therapy is considered an appropriate option per local clinical guidelines (i.e. participants should not be considered eligible for endocrine-based treatment)
Evidence of progression to the combination of mTORi and endocrine therapy given as the last therapy prior to study entry
Progression on or after endocrine treatment
Prior treatment with other chemotherapeutic agents, trastuzumab, endocrine and radiation therapy is permitted;
Completed definitive therapy consisting of surgery, chemotherapy or radiation therapy at least 180 days ago (may continue on Herceptin or endocrine therapy)
Has received adjuvant endocrine therapy (selective estrogen receptor modulator [SERM] alone, gonadotropin-releasing hormone [GnRH] analogue plus SERM or aromatase inhibitors [AI]) for >= 18 months but =< 30 months for early breast cancer\r\n* Note: patients who have received neo/adjuvant endocrine treatment within a clinical trial and patients who have received pharmaco-prevention are eligible
The adjuvant endocrine therapy must have stopped within 1 month prior to enrollment
Completion of all primary therapy (with the exception of ongoing endocrine or trastuzumab therapy), including surgery, radiation, and/or chemotherapy greater than 4 weeks prior to study enrollment
Have completed all surgery, radiation, and/or chemotherapy treatments at least 6 months previously; may still be receiving trastuzumab or endocrine adjuvant therapy
May use adjuvant endocrine therapy if use will be continued for duration of study intervention
Stage I-III breast cancer\r\n* Treatment status: At least 6 months and no more than 5 years after the conclusion of active breast cancer therapy, including surgery, radiation therapy and (neo)adjuvant chemotherapy, if administered\r\n*NOTE: Adjuvant HER2-targeted therapy and endocrine therapy may still be ongoing at the time of study enrollment; those on endocrine therapy must have been on their current endocrine regimen for at least four weeks prior to study enrollment and must not have plans to change endocrine regimens during the study period
Concurrent endocrine therapy permissible
Breast cancer survivors treated with chemotherapy with no evidence of disease with treatment completed at least six months prior to study participation with or without current endocrine therapy
Women who are receiving endocrine therapy at the time of recruitment are eligible for the study
Completed active treatment (e.g., chemotherapy, radiation therapy, surgery) 6 months-5 years\r\nago (current use of endocrine therapy is acceptable)
No previous chemotherapy, endocrine, therapy or radiation therapy with therapeutic intent for this cancer
Progression through at least one prior line of endocrine therapy
Participant is scheduled to initiate treatment with everolimus combined with exemestane or another form of endocrine therapy
Patients receiving systemic chemotherapy or radiation therapy within 4 weeks of the start of everolimus (Note: there is no wash-out period for endocrine therapy)
Concomitant trastuzumab and anti-endocrine therapies are permitted; if taking anti-endocrine therapy must have been taking for at least 3 months prior to enrollment
Participants who have received endocrine therapy within 1 year prior to screening breast MRI
>= 6 months from all previous breast cancer treatment (including endocrine therapy)
COHORT A2: Diagnosis of breast cancer having completed any cytotoxic chemotherapy, radiation or surgery at least 3 months prior to study entry; may continue to take endocrine therapy and/or maintenance trastuzumab
At least 3 months after completion of any cytotoxic chemotherapy or radiation or surgery; may continue to take endocrine therapy and/or maintenance trastuzumab
May use adjuvant endocrine therapy if use will be continued for duration of study period
Subjects with prior breast cancer must be off all systemic therapy (including endocrine agents) for at least 2 years prior to registration
Prior endocrine therapy with or without a CDK 4/6 inhibitor unless endocrine therapy is not indicated (ie, short relapse-free interval while on adjuvant endocrine therapy [endocrine resistance]; rapidly progressing disease/visceral crisis; or endocrine intolerance). Any targeted therapies approved for HER2 negative, HR positive MBC, including everolimus, are permitted as prior therapy. There is no limit to the number of prior endocrine therapies.
Patients may enroll within 10 years of breast cancer diagnosis, as long as there is a plan for at least 1 more year of adjuvant endocrine therapy
>= 6 months from all previous breast cancer treatment (including surgery for invasive cancer, chest wall radiotherapy, chemotherapy, trastuzumab and endocrine therapy)
DISEASE CHARACTERISTICS:\n\n          -  Confirmed diagnosis of prior operable, noninflammatory breast cancer meeting the\n             following criteria:\n\n               -  Steroid hormone receptor-positive tumors (estrogen receptor and/or progesterone\n                  receptor), determined by immunohistochemistry, after primary surgery and before\n                  commencement of prior endocrine therapy\n\n               -  Prior local treatment including surgery with or without radiotherapy for primary\n                  breast cancer with no known clinical residual loco-regional disease\n\n               -  Following primary surgery, eligible patients must have had evidence of lymph node\n                  involvement either in the axillary or internal mammary nodes, but not\n                  supraclavicular nodes\n\n               -  Clinically disease-free\n\n          -  Must have completed 4-6 years of prior adjuvant selective estrogen receptor modulators\n             (SERMs), aromatase inhibitors (AIs), or a sequential combination of both\n\n               -  When calculating 4-6 years, neoadjuvant endocrine therapy should not be included\n\n          -  No evidence of recurrent disease or distant metastatic disease\n\n          -  No prior bilateral breast cancer\n\n        PATIENT CHARACTERISTICS:\n\n          -  Female\n\n          -  Must be postmenopausal by any of the following criteria:\n\n               -  Patients of any age who have had a bilateral oophorectomy (including radiation\n                  castration AND amenorrheic for > 3 months)\n\n               -  Patients 56 years old or older with any evidence of ovarian function must have\n                  biochemical evidence of definite postmenopausal status (defined as estradiol,\n                  luteinizing hormone [LH], and follicle-stimulating hormone [FSH] in the\n                  postmenopausal range)\n\n               -  Patients 55 years old or younger must have biochemical evidence of definite\n                  postmenopausal status (defined as estradiol, LH, and FSH in the postmenopausal\n                  range)\n\n                    -  Patients who have received prior luteinizing-hormone releasing-hormone\n                       (LHRH) analogues within the last year are eligible if they have definite\n                       evidence of postmenopausal status as defined above\n\n          -  Clinically adequate hepatic function\n\n          -  No bone fracture due to osteoporosis at any time during the 4-6 years of prior therapy\n\n          -  No prior or current malignancy except adequately treated basal cell or squamous cell\n             carcinoma of the skin, in situ carcinoma of the cervix or bladder, or contra- or\n             ipsilateral in situ breast carcinoma\n\n          -  No other nonmalignant systemic diseases (cardiovascular, renal, lung, etc.) that would\n             prevent prolonged follow-up\n\n          -  No psychiatric, addictive, or any other disorder that compromises compliance with\n             protocol requirements\n\n        PRIOR CONCURRENT THERAPY:\n\n          -  See Disease Characteristics\n\n          -  More than 12 months since prior and no other concurrent endocrine SERM/AI therapy\n\n          -  Any type of prior adjuvant therapy allowed including, but not limited to, any of the\n             following:\n\n               -  Neoadjuvant chemotherapy\n\n               -  Neoadjuvant endocrine therapy\n\n               -  Adjuvant chemotherapy\n\n               -  Trastuzumab (Herceptin®)\n\n               -  Ovarian ablation\n\n               -  Gonadotropin releasing hormone analogues\n\n               -  Lapatinib ditosylate\n\n          -  No concurrent hormone-replacement therapy, bisphosphonates (except for treatment of\n             bone loss), or any other investigational agent
Patient must NOT be planning to receive molecular targeted therapy (such as everolimus or palbociclib) nor HER2 directed therapy in addition to endocrine therapy
Patient must NOT have received prior endocrine therapy for metastatic disease (i.e., must be first-line endocrine therapy for metastatic disease)
Patient is not now, and never has received adjuvant endocrine therapy OR patient is currently receiving or has received adjuvant endocrine therapy in the past, AND adjuvant endocrine therapy was initiated > 2 years prior to diagnosis of metastatic disease\r\n* Note: patients who developed metastatic disease while still receiving adjuvant endocrine therapy must have a planned change in the type of endocrine agent used for subsequent metastatic disease treatment; patient is not receiving blocking adjuvant therapy (such as toremifene or tamoxifen) OR patient is receiving blocking adjuvant therapy, but will stop this therapy a minimum of 60 days prior to FES-PET/CT while still complying with the study timeline
Patients planning to receive neoadjuvant chemotherapy/endocrine therapy after the clinical breast MRI and before the research breast PET/MRI examination, those currently undergoing neoadjuvant chemotherapy/endocrine therapy, or those who have received chemotherapy/endocrine therapy within 6 months prior to the MRI
No prior endocrine therapy for metastatic disease is allowed (i.e. must be first-line endocrine therapy for metastatic disease). However, a history of adjuvant endocrine therapy is allowed, as long as the date of diagnosis of metastatic disease is > 2 years following initiation of adjuvant endocrine therapy. Patients who develop metastatic disease while still receiving adjuvant endocrine therapy must have a change in the type of endocrine agent used for subsequent metastatic disease treatment. Patients on blocking adjuvant therapy (with a blocking agent such as toremifene or tamoxifen) must be off the agents for a minimum of 60 days to allow for adequate uptake of FES.
Prior or chemotherapy or endocrine therapy is permitted
History of progression or recurrence of disease while on an endocrine targeted therapy containing regimen as assessed by medical record review of breast cancer history at screening
Patients planning to start new endocrine targeted therapy (any line of therapy is acceptable and any endocrine therapy is allowed)
Patients must be selected for an endocrine targeted therapy regimen for treatment of their breast cancer by the referring oncologist; selected treatments may be part of experimental treatment protocols for which the patient would be separately consented
Patients undergoing neoadjuvant endocrine therapy
Patients who have had any prior chemotherapy, radiotherapy, or endocrine therapy for the treatment of breast cancer.
Patients may not be receiving any other investigational agents or any concomitant antineoplastic therapy, with the exceptions of octreotide long-acting release (LAR) (for neuroendocrine tumors) and endocrine therapy (for prostate, breast, or gynecologic malignancies)
Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer or localized breast cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
Patients who have received prior chemotherapy for any abdominal or pelvic tumor within the last three years are excluded; patients may have received prior adjuvant chemotherapy and radiotherapy for localized breast cancer, provided that it was completed more than 2 years prior to registration, the patient remains free of recurrent or metastatic disease and hormonal therapy has been discontinued
Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
Patients who have received prior chemotherapy for any abdominal or pelvic tumor within the last five years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.
Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
Patients who have previously received chemotherapy for any abdominal or pelvic tumour, including treatment for prior diagnosis at an earlier stage for their ovarian, fallopian tube or primary peritoneal cancer. (Patients who have received prior adjuvant chemotherapy for localised breast cancer may be eligible, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease).
Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of cervical cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
Patients who have received prior chemotherapy for any abdominal or pelvic tumor including neo-adjuvant chemotherapy for their ovarian, primary peritoneal or fallopian tube cancer are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.
Patients who have received prior chemotherapy for any abdominal or pelvic tumor other than for treatment of ovarian carcinoma within the last 3 years are excluded; patients may have received prior chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration and the patient remains free of recurrent of metastatic disease
Patients who have received prior chemotherapy for any abdominal or pelvic tumor including neo-adjuvant chemotherapy for their ovarian or primary peritoneal cancer are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
Patients who have received prior cytotoxic chemotherapy are ineligible; patients may have received prior adjuvant hormonal therapy for localized breast cancer, provided that it was completed prior to registration, and that the patient remains free of recurrent or metastatic disease