More than two prior lines (may be combination regimens) of chemotherapy for angiosarcoma (neoadjuvant/adjuvant treatment does not count as a line of treatment)
Completed at least 6 cycles of neoadjuvant or adjuvant chemotherapy containing anthracyclines, taxanes or the combination of both; prior platinum as potentially curative treatment for prior cancer (e.g. ovarian) or as adjuvant or neoadjuvant treatment for breast cancer is allowed; (for neoadjuvant patients all chemotherapy should be delivered prior to surgery; no further cycles of chemotherapy post-surgery are allowed)
First-line patients who have disease progression within 12 months of neoadjuvant or adjuvant treatment with chemotherapy.
RANDOMIZED PHASE II CLINICAL TRIAL: Patients may have received adjuvant or neoadjuvant chemotherapy with or without carboplatin or gemcitabine before randomization with an interval not less than 12 months since completion of adjuvant/neoadjuvant treatment
For Parts A, B, C, D, E, G and I: Have received prior systemic chemotherapy for metastatic disease. However, the participant may have received prior systemic chemotherapy in the neoadjuvant or adjuvant setting.
ADJUVANT COHORT: Patients who already started on adjuvant hormonal therapy are eligible under the following conditions:\r\n* For the 26 patients who enrolled in the initial cohorts and derived benefit from neoadjuvant PD 0332991 (C1D1 Ki67 > 2.7% and C1D15 Ki67 =< 2.7%), adjuvant PD 0332991 should be initiated as soon as possible if adjuvant hormonal therapy has been initiated and the patient has completed radiation if indicated\r\n* For patients who enrolled in the endocrine resistant cohort and derived benefit from neoadjuvant PD 0332991 (C1D15 Ki67 =< 10%), adjuvant PD 0332991 should be initiated within 6 months or sooner after initiation of adjuvant hormonal therapy.
Histologically confirmed stage IV NSCLC, with no prior systemic anti-cancer therapy of any kind (including EGFR and ALK inhibitors), prior definitive chemoradiation for locally advanced disease is permitted as long as the last administration of chemotherapy or radiation (whichever was given last) occurred at least 6 months prior to enrollment; prior adjuvant or neoadjuvant chemotherapy for early stage lung cancer is permitted if completed at least 6 months prior to initiating study treatment
Unresolved toxicity from all radiation, adjuvant/ neoadjuvant chemotherapy, other targeted treatment including investigational treatment
No limit on prior lines of therapy for metastatic disease; prior adjuvant or neoadjuvant chemotherapy does not count as a prior line of therapy as long as completion of the adjuvant or neoadjuvant therapy was more than 1 year prior to patient enrollment
Prior chemotherapy for prostate cancer except if administered in neoadjuvant or adjuvant setting
Prior neoadjuvant or adjuvant therapy is allowed provided administered in the curative setting in patients with localized disease
Platinum-resistant or -sensitive after completing first-line treatment (debulking surgery and adjuvant or neoadjuvant treatment with standard of care treatment such as carboplatin and paclitaxel). Subjects may have had any number of subsequent lines of chemotherapy.
Must have received prior platinum containing chemotherapy for advanced/metastatic non-small cell lung cancer, or have refused or be ineligible for such therapy; prior neoadjuvant/adjuvant platinum containing chemotherapy will count has having received prior platinum, provided that disease recurred within 6 months of completion of neoadjuvant/adjuvant therapy
Patient may have had prior neoadjuvant and/or adjuvant therapy (chemotherapy, vaccines or experimental agents) within 4 weeks prior to randomization, if the PSA rise and PSADT were documented after the testosterone level was > 150 ng/dL
Have received prior platinum therapy in the past 3 months (Part 1) or 6 months in the adjuvant or neoadjuvant setting (Part 2).
PART I: Adults with HER2+ bladder cancer in the adjuvant setting (adjuvant bladder cancer patients):\r\n* Tumor stage T3a, T3b, T4a, T4b and any node positive disease regardless of tumor stage\r\n* Tumors that are HER2 1+, 2+ or 3+ by IHC or have a Vysis FISH result >= 1.8\r\n* Status-post primary cystectomy with curative intent\r\n* May or may not have received neoadjuvant cisplatin-based combination chemotherapy per National Comprehensive Cancer Network (NCCN) guidelines\r\n* May or may not have received adjuvant radiotherapy or chemotherapy based on pathologic risk per NCCN guidelines\r\n* Greater than or equal to 6 weeks s/p primary surgery with curative intent
No prior chemotherapy for inoperable locally advanced or mUC. For patients who received prior adjuvant/neoadjuvant chemotherapy or chemo-radiation for urothelial carcinoma, a treatment-free interval > 12 months between the last treatment administration and the date of recurrence is required in order to be considered treatment naive in the metastatic setting
Patients who have received a total of at least 36 weeks of trastuzumab therapy (including neoadjuvant and adjuvant settings)
There is no restriction on the use of fluoropyrimidine-containing regimen in the neoadjuvant or adjuvant setting
Neoadjuvant chemotherapy or adjuvant chemotherapy delivered before radiation
Subjects who have documented disease recurrence within 6 months of completing neoadjuvant or adjuvant chemotherapy for limited disease will be eligible for study; subjects who recur greater than 6 months after completing adjuvant chemotherapy will not be eligible unless they receive additional chemotherapy for advanced disease
Prior neoadjuvant or adjuvant systemic therapy or local intravesical chemotherapy or immunotherapy is permitted if such therapy was completed at least 12 months prior to the initiation of study treatment and if all toxicities from such therapy have improved to grade 1 or stabilized or resolved
Has received prior chemotherapy for NSCLC with the exception of neoadjuvant or adjuvant platinum-based chemotherapy for NSCLC completed > 6 months prior to enrollment
Patients who had prior carboplatin in the metastatic setting are not eligible\r\n* Note: Prior carboplatin as neoadjuvant or adjuvant treatment is permitted
Subjects must have progression of disease within 12 months of platinum-containing chemotherapy (chemotherapy could have been given in the neoadjuvant, adjuvant or metastatic settings) for urothelial cancer
Disease recurrence less than 6 months from the last dose of prior neoadjuvant or adjuvant therapy (including VEGF-R TKI)
Patients who received adjuvant or neoadjuvant platinum-doublet chemotherapy (after surgery and/or radiation therapy) and developed recurrent or metastatic disease within 6 months of completing therapy are not excluded.
Patients should be chemotherapy naive in the stage IV non-small cell lung cancer (NSCLC) setting, with the exception of chemotherapy for neoadjuvant or adjuvant treatment that completed at least 6 months before the study treatment
Patients may have received adjuvant or neoadjuvant chemotherapy with or without trastuzumab and pertuzumab with an interval greater than 12 months since completion of adjuvant/neoadjuvant treatment
Completion of neoadjuvant or adjuvant chemotherapy
Prior adjuvant or neoadjuvant therapy for localized or locally advanced RCC is allowed provided recurrence occurred = or > 6 months after the last dose of the adjuvant or neoadjuvant therapy
Must have received at least 1 prior systemic therapy for advanced disease (does not include adjuvant/neoadjuvant therapy in a curative setting)
Patients who received adjuvant or neoadjuvant chemotherapy (after surgery and/or radiation therapy) and developed recurrent or metastatic disease within 6 months of completing therapy are eligible and the adjuvant or neoadjuvant chemotherapy will count as a line of therapy as above
INCLUSION CRITERIA FOR TNBC: Patients must have received standard adjuvant, neoadjuvant, and/or metastatic chemotherapy per National Comprehensive Cancer Network (NCCN) or institutional practice; no maximum on number of prior systemic treatment regimens
Randomized phase II: be treatment naive in the stage IV setting; subjects who received platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, and developed recurrent (local or metastatic) disease < 6 months of completing therapy are ineligible for this arm; subjects with recurrent disease >= 6 months after completing a platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, who also subsequently progressed during or after a systemic regimen given to treat the recurrence, are eligible for this arm
At least one prior line of systemic therapy for the sarcoma diagnosis (neoadjuvant, adjuvant or metastatic disease)
Any neoadjuvant or adjuvant chemotherapy regimen is permitted; prior chemotherapy for the treatment of this breast cancer is not required
Prior adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has occurred during or within 12 months after the last dose of treatment.
Patients who have had surgery or radiotherapy with or without neoadjuvant or adjuvant chemotherapy (the wash-out period will be at least 1 month)
No prior first line systemic treatment (prior adjuvant or neoadjuvant treatment is permitted); subjects whose disease has progressed after 6 months of last systemic chemotherapy or chemo-radiation in the adjuvant or neoadjuvant setting are eligible
Have been a participant in Hopkins Institutional Review Board (IRB) protocol (J0810) application number 00-01-58-58 entitled \A randomized three-arm neoadjuvant and adjuvant feasibility and toxicity study of a GM-CSF secreting allogeneic pancreatic cancer vaccine administered either alone or in combination with either a single intravenous dose or daily metronomic oral doses of cyclophosphamide for the treatment of patients with surgically resected adenocarcinoma of the pancreas\ (the J0810 cohort), or IRB protocol (J1568) application number 00-05-05-17 entitled “A Randomized Study of a GM-CSF secreting allogeneic pancreatic cancer vaccine with or without a PD-1 Blockade Antibody (Nivolumab) for the Neoadjuvant and Adjuvant Treatment of Patients with Surgically Resectable Adenocarcinoma of the Pancreas” (the 1568 cohort) or have never received any type of pancreatic cancer vaccine/immunotherapy, had the Whipple surgery within 18 months and completed the planned adjuvant chemotherapy and/or chemoradiation (the vaccine-naive cohort)
Stage I of the trial: newly diagnosed disease for which neoadjuvant or adjuvant chemotherapy is planned in the curative setting, or metastatic disease
Treatment by imatinib as neoadjuvant/adjuvant therapy within 4 weeks prior baseline
Subjects whose adjuvant or neoadjuvant treatment for early stage breast cancer was completed within 6 months prior to entry into the study.
No prior systemic therapy for RCC with the following exception: i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets VEGF or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy
Completed last cycle of chemotherapy (which can be given in the adjuvant and/or neoadjuvant setting) >= 60 days but not >= 365 days prior to randomization
Patients who have not received prior neoadjuvant cisplatin chemotherapy must be ineligible for or refuse cisplatin-based adjuvant chemotherapy
Relapsed after or refractory to one or two prior lines of chemotherapy for advanced or metastatic/recurrent disease (at least one cycle each) which have not included a PD-L1 or FGFR inhibitor; at least one regimen should have included a platinum agent unless contraindicated for the subject; prior neoadjuvant or adjuvant chemotherapy (without a PD-L1 or FGFR inhibitor) is permitted and will not be counted as first-line chemotherapy, as long as the subject has not progressed within 12 months of the last dose; however, a regimen of neoadjuvant or adjuvant chemotherapy will be counted as first-line chemotherapy if the patient progressed within 12 months of the last dose
Prior therapy:\r\n* At least 1 prior chemotherapy regimen for treatment of metastatic breast cancer, and/or\r\n* Recurrence within 12 months of completion of neoadjuvant/adjuvant chemotherapy, and/or\r\n* For patients with inflammatory breast cancer but no distant metastases, progression through standard (anthracycline- and taxane-based) neoadjuvant chemotherapy is required
Must have received trastuzumab (neoadjuvant, adjuvant or metastatic setting)
No prior neoadjuvant/adjuvant therapy for DCIS diagnosis
The participant has disease progression during or within 4 months after last dose of first-line chemotherapy or during or within 6 months after the last dose of neoadjuvant or adjuvant therapy.
Prior exposure to taxane in the adjuvant, neoadjuvant or metastatic setting
Patient has completed multi-agent adjuvant or neoadjuvant chemotherapy of ? 4 cycles or ? 12 weeks which included taxanes prior to screening
Previous therapy for locally advanced, unresectable or metastatic gastric/GEJ cancer. Participant may have received prior neoadjuvant or adjuvant therapy as long as it was completed at least 6 months prior to randomization
Regimens received in the adjuvant/neoadjuvant setting or for locally advanced breast cancer within the past 6 months will also be considered toward the maximum of 2 prior lines of therapy. Adjuvant/neoadjuvant chemotherapy for one cancer event will count as one prior line of therapy, if received within the past 6 months.
Prior systemic therapy for this type of sarcoma; neoadjuvant or adjuvant therapy more than two years prior would not apply
Prior neoadjuvant, adjuvant, or palliative chemotherapy for ATC is allowed.
Metastatic disease with documented disease progression following previous treatment with at least one, but no more than 2 prior therapies, with one of the prior therapies having been either gemcitabine-based or fluoropyrimidine-based therapy. Neoadjuvant and/or adjuvant therapies for localized resectable or unresectable PDAC each count as a line of therapy if multiagent chemotherapy regimens were administered (and neoadjuvant regimen was different than adjuvant regimen) and if the participant progressed with metastatic disease while taking or within 6 months of completion of (neo)adjuvant therapy.
Prior ADT given for < 39 months in duration and > 9 months before randomization as neoadjuvant/adjuvant therapy.
Patients must have had prior treatment with anthracyclines and/or taxanes (resistant) or platinum including adjuvant or neoadjuvant therapy
Individuals who have received only neoadjuvant or adjuvant therapy for gastric adenocarcinoma
Prior chemotherapy for advanced BC. Previous adjuvant/neoadjuvant chemotherapy is allowed (carboplatin, cisplatin or gemcitabine only if > 12 months has passed since last administration).
Patient has received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant or any CDK4/6 inhibitor.
Prior neoadjuvant or adjuvant treatment with a non steroidal aromatase inhibitor (ie, anastrozole or letrozole) with disease recurrence while on or within 12 months of completing treatment
Received at least one prior pemetrexed-based chemotherapy for unresectable disease, unless within 3 months of receiving platinum-pemetrexed therapy for neoadjuvant or adjuvant treatment that has been unsuccessful
No prior use of anthracyclines and taxanes for metastatic disease or in the adjuvant or neoadjuvant setting
Has received systemic therapy for the treatment of their stage IV NSCLC. Completion of treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease.
Prior therapy with interferon alfa (in neoadjuvant, adjuvant, or metastatic settings) (Part 1A only)
Subjects who received platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, and developed recurrent (local or metastatic) disease within 6 months of completing therapy are eligible
Prior therapy should have included a taxane and/or anthracycline (unless contraindication to those) in the neoadjuvant, adjuvant, or advanced/metastatic setting. a. Hormone receptor positive patients must also have hormone resistant disease (progression during at least one prior hormonal therapy) for which chemotherapy is indicated.
Must have completed preoperative (neoadjuvant) chemotherapy. NOTE: Acceptable preoperative regimens include an anthracycline or a taxane, or both. Patients may NOT have received cisplatin as part of their neoadjuvant therapy regimen. Patients who received preoperative therapy as part of a clinical trial may enroll. No adjuvant chemotherapy after surgery other than that specified in this protocol is allowed. Adjuvant bisphosphonate use is allowed.
Prior chemotherapy or immunotherapy for metastatic urothelial bladder cancer; prior neoadjuvant or adjuvant chemotherapy with first progression > 12 months is allowed
Did not receive neoadjuvant or adjuvant treatment (chemotherapy, radiotherapy, or both) for their disease within the last 6 months
Any prior systemic or investigational therapy for metastatic pancreatic cancer; systemic therapy administered alone or in combination with radiation in the adjuvant or neoadjuvant setting is permissible as long as it was completed > 6 months prior to the time of study registration
Prior adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has occurred during or within 12 months after the last dose of treatment
The participant has documented disease progression during or within 4 months after the last dose of first-line chemotherapy for metastatic disease, or during or within 6 months after the last dose of neoadjuvant or adjuvant therapy.
No prior systemic chemotherapy for metastatic disease (adjuvant or neoadjuvant platinum-based chemotherapy with recurrence >12 months since completion of therapy is allowed)
Prior chemotherapy for prostate cancer, except if administered in the adjuvant/neoadjuvant setting
Prior adjuvant or neoadjuvant therapy if disease progression or relapse has occurred during or within 12 months after the last dose of treatment
Participants who received prior adjuvant/neoadjuvant chemotherapy and progressed within 12 months of treatment with a platinum-containing adjuvant/neoadjuvant regimen were considered as second-line participants.
Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, everolimus, or any CDK4/6 inhibitor
Subject has received prior cytotoxic chemotherapy (including definitive chemoradiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy.
Progression after neoadjuvant or adjuvant platinum based chemotherapy if the recurrence occurred while on neoadjuvant/adjuvant chemotherapy or within 6 months since the last administration of such therapy.
Patients may have received prior neoadjuvant and/or adjuvant hormonal therapy, for non-metastatic disease but it must not have lasted for more than 36 months; at least 12 months must have elapsed since completion of androgen deprivation therapy in the neoadjuvant and/or adjuvant setting
Patients with a history of prior neoadjuvant/adjuvant hormone therapy are eligible provided they have received twenty four or less months of hormone treatment (single or combination treatment, excluding orchiectomy); neoadjuvant/adjuvant hormone therapy must have been discontinued at least 6 months prior to registration; this is intended to exclude patients who might have been rendered indirectly androgen insensitive
Prior platinum allowed as long as no breast cancer progression occurred on treatment or if given in adjuvant/neoadjuvant setting at least 12 months from last dose to study entry elapsed.
Must have completed preoperative (neoadjuvant) chemotherapy. NOTE: Acceptable preoperative regimens include an anthracycline or a taxane, or both. Participants who received preoperative therapy as part of a clinical trial may enroll. Participants may not have received adjuvant chemotherapy after surgery prior to randomization. Bisphosphonate use is allowed.
Prior chemotherapy for prostate cancer except if administered in the adjuvant/neoadjuvant setting
Active second cancer other than specified; active cancer refers to cancer that requires systemic chemotherapy or biological therapy within 6 months of the study entry; patients who have received only hormonal therapy in the neoadjuvant or adjuvant setting in the past 6 months may participate in this study
PRE-REGISTRATION INCLUSION CRITERIA: Planning to receive best practice adjuvant or neoadjuvant chemotherapy according to institutional guidelines; adjuvant tamoxifen or aromatase inhibitors treatment will be allowed for hormone receptor-positive patients; patients who have failed neoadjuvant endocrine therapy will also be eligible
Evidence of disease progression documented within 6 months after completion of prior neoadjuvant or adjuvant cytotoxic chemotherapy, or both, or radiotherapy for GEJ adenocarcinoma
Prior therapy for NSCLC that may include surgery, radiation therapy, immunotherapy and/or ? 2 prior chemotherapy regimens (such as neoadjuvant/adjuvant treatment), however only 1 chemotherapy regimen in the metastatic setting is allowed.
Patients receiving preoperative (Neoadjuvant) and postoperative adjuvant chemotherapy (within 12 weeks of surgery) with the same agent(s) will be considered to have received a single chemotherapy regimen.
Patients may have received prior neoadjuvant or adjuvant endocrine therapy. In the case of neoadjuvant or adjuvant NSAI (letrozole/anastrozole) therapy patients must have completed therapy at least 1 year prior to study enrollment.
No prior systemic treatment for advanced or metastatic colorectal cancer is allowed; prior regional chemotherapy (e.g., hepatic arterial infusion) is also not allowed; patients may have received previous neoadjuvant or adjuvant chemotherapy and/or chemoradiation per institutional standard of care; the last course of adjuvant therapy must have been concluded > 12 months prior to colorectal cancer recurrence
Previous treatment with anti-HER2 agents for breast cancer, except trastuzumab and/or lapatinib in the neoadjuvant or adjuvant setting
One prior adjuvant or neoadjuvant therapy for localized or locally advanced RCC is allowed provided recurrence occurred ? 6 months after the last dose of the adjuvant or neoadjuvant therapy
Prior neoadjuvant and/or adjuvant chemotherapy for breast cancer is allowed
Patients who have progressed/recurred following neoadjuvant/adjuvant chemotherapy for earlier stage disease, if completed within the previous 6 months, are eligible.
Prior neoadjuvant/adjuvant hormonal or chemotherapy is allowed if it was last used > 12 months prior to enrollment
Prior erbB-2 inhibitor other than trastuzumab or lapatinib in the neoadjuvant or adjuvant setting
Progression/recurrence within 12 months after completion of adjuvant or neoadjuvant therapy
Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy).
For subjects receiving adjuvant therapy only, subjects must not have received prior neoadjuvant treatment. Endocrine treatment for less than 30 days prior to surgery is not considered prior neoadjuvant treatment
Prior treatment with taxanes if given as full-dose chemotherapy for advanced disease; as neoadjuvant therapy, taxanes cannot be used in 6 months prior to enrollment
Received only 1 prior systemic chemotherapy regimen for Stage IIIb, IV, or recurrent disease not including neoadjuvant and/or adjuvant therapy. (NOTE: Exceptions may be allowed based on prior treatment regimens and tumor types in agreement with protocol requirements.)
Received up to 2 prior chemotherapy regimens (not including neoadjuvant/adjuvant therapy) for advanced or metastatic disease
Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy).
Neoadjuvant or adjuvant chemotherapy or chemoradiotherapy for pancreatic adenocarcinoma
A subject with non-metastatic castration-resistant prostate cancer (CRPC) may not have received prior chemotherapy unless in the neoadjuvant or adjuvant setting > 24 months ago and may not have received prior zoledronic acid or denosumab
Patients who have received more than two prior lines of antineoplastic therapy for advanced disease. Chemotherapy administered as neoadjuvant or adjuvant treatment more than six months prior to study enrollment is not considered a prior line of therapy for purposes of this study.
Patient's naïve to first-line therapy for the advanced stage of the disease. Previous neoadjuvant or adjuvant therapy is allowed for patients who successfully underwent complete radical surgery and if last treatment was administered more than 12 months prior to the start of the study treatment, i.e., D1 of Cycle 1.
Patients may have had any number of prior surgeries, radiation and/or chemotherapy regimens as adjuvant, neoadjuvant or palliative therapy for the treatment of their disease
Prior adjuvant or neoadjuvant systemic therapy within 12 months of randomization
Adjuvant or neoadjuvant therapy for AGC is allowed.
At least 12 months since prior neoadjuvant or adjuvant chemotherapy
The last course of adjuvant or neoadjuvant chemotherapy must have ended > 12 months prior to colorectal cancer recurrence
Relapsed or refractory (lack of response) to ?1 course of systemic therapy regimen(s), excluding adjuvant or neoadjuvant chemotherapy, and is incurable by either surgery or radiation.
Disease recurrence within one year after neoadjuvant or adjuvant platinum-based systemic chemotherapy, measured from the date of last dose of chemotherapy or surgery until the day the informed consent is signed
Previous chemotherapy for locally advanced or metastatic gastric carcinoma (adjuvant or neoadjuvant chemotherapy must be completed at least 6 months prior to randomization)
Has received systemic therapy for the treatment of advanced stage NSCLC. Completion of treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease
Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrent disease of less than 6 months
If prior adjuvant or neoadjuvant chemotherapy, the last dose of adjuvant or neoadjuvant treatment was administered at least 6 months prior to randomization.
Patients who had adjuvant or neoadjuvant therapy for non-metastatic disease given within the last 12 months.
Relapse or failure of one first line chemotherapy (in the case of recurrent disease one additional prior regimen is allowed for adjuvant, neoadjuvant or neoadjuvant plus adjuvant therapy).
Prior taxanes (except for adjuvant or neoadjuvant therapy more than 6 months prior to treatment day 1) (phase II)
Scheduled to begin an appropriate adjuvant or neoadjuvant chemotherapy regimen as defined by National Comprehensive Cancer Network (NCCN) guidelines
Subjects do not need to have measurable or evaluable disease; chemotherapy may be administered in the neoadjuvant, adjuvant, or metastatic setting
Cohort 1: First-line soft tissue sarcoma of intermediate or high grade. Adjuvant or neoadjuvant chemotherapy allowed if no tumor recurrence for at least 12 months since the last measurement, beginning or end of last chemotherapy.
Post neoadjuvant or adjuvant chemotherapy, if prescribed
Prior chemotherapy in the neoadjuvant or adjuvant setting
Participants will have completed surgery (lumpectomy or mastectomy) with or without neoadjuvant or adjuvant chemotherapy and with or without radiation
Scheduled to receive chemotherapy in the neoadjuvant or adjuvant setting
Patients with histologically confirmed breast cancer scheduled to receive chemotherapy with doxorubicin and cyclophosphamide (adjuvant or neoadjuvant)
Planning to undergo neoadjuvant or adjuvant chemotherapy with curative intent
SCREENING PHASE: Plan to receive adjuvant or neoadjuvant chemotherapy that includes weekly paclitaxel
INTERVENTION PHASE: Receiving adjuvant or neoadjuvant chemotherapy that includes a taxane
Stage I-III female breast cancer patients who have undergone chemotherapy (either neoadjuvant or adjuvant) 6 - 60 months prior to recruitment
Received any prior adjuvant or neoadjuvant therapy for NSCLC.
Neoadjuvant or adjuvant therapy of any kind
Patient may have had any number of prior chemotherapy regimens in the adjuvant/neoadjuvant and/or metastatic setting (including none)
Patient may have had any number of prior treatments with anti-HER2 strategies in the adjuvant/neoadjuvant and/or metastatic setting (including none)
Patient may have had any number of prior hormonal therapies in the adjuvant/neoadjuvant and/or metastatic setting (including none)
Prior therapy (at least one completed dose) with a taxane-containing regimen in the neoadjuvant or adjuvant setting
Prior therapy with an anthracycline-containing regimen in the neoadjuvant, adjuvant, or metastatic setting, where indicated by local regulation or Investigator judgment.
Subjects who have received prior adjuvant therapy for pancreatic adenocarcinoma are eligible if neoadjuvant and adjuvant therapy (including chemotherapy and/or radiotherapy) was fully completed more than 4 months before the start of study treatment. In this case, prior Gem and/or NP is allowable
Gastric Carcinoma (including Gastro-Esophageal Junction Adenocarcinoma): progression following at least one prior line of standard therapy that contained a fluoropyrimidine and/or platinum and/or taxane agent; prior adjuvant or neoadjuvant therapy is counted as one regimen, provided that disease progression occurs within 6 months after the completion of adjuvant or neoadjuvant therapy; HER2 negative subjects (defined by HER2 ? 2+ by IHC) by medical history; archival tissue or fresh tumor biopsy
For the purposes of this study, neoadjuvant and/or adjuvant chemotherapy regimens do not count as a prior line of therapy.
For participants who received prior adjuvant/neoadjuvant chemotherapy or chemo-radiation for urothelial carcinoma, a treatment-free interval more than (>) 12 months between the last treatment administration and the date of recurrence is required in order to be considered treatment naive in the metastatic setting