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