Progression of disease after  or  prior regimens in the metastatic setting
More than one prior chemotherapy regimen administered in the metastatic setting.
Patients must meet at least one of the following criteria:\r\n* Disease progression any time after non-steroidal aromatase inhibitor (AI) use in the advanced disease setting\r\n* Relapse while on or within =<  months of end of adjuvant non-steroidal AI therapy with or without prior endocrine therapy for advanced disease\r\n* NOTE: In either setting, treatment with any prior endocrine therapy must be completed >=  weeks prior to course  day  (CD) of study treatment with the exception of exemestane which is permitted in the advanced disease setting within =<  weeks immediately prior to CD; prior adjuvant exemestane is allowed if the disease free interval is >  months from the discontinuation of exemestane; prior faslodex, everolimus, palbociclib or other cyclin-dependent kinase (CDK) inhibitor (e.g. ribociclib, abemaciclib) use are allowed and must have been completed >=  weeks prior to CD; failure to adhere to this washout guideline will result in a protocol violation
Patients may have had prior systemic therapy in the adjuvant setting; however this adjuvant treatment must not have included a CTLA or PD pathway blocking antibody or a BRAF/MEK inhibitor; also, patients may not have had any prior systemic treatment for advanced (measurable metastatic) disease
Patients must have received irinotecan therapy in the metastatic setting; there are no limitation on number of prior therapies in the metastatic setting
For dose-expansion cohort only: no more than two prior systemic chemotherapy-containing regimens in the advanced/metastatic setting (excluding trastuzumab emtansine, which is considered a targeted cytotoxic agent)
Prior therapy is allowed as follows:\r\n* Platinum chemotherapy in the adjuvant setting is allowed, if the last platinum dose was >  months before identification of metastatic disease; platinum-based chemotherapy in the metastatic setting is not permitted\r\n* History of prior anthracycline (e.g. doxorubicin, epirubicin) and taxane-based (e.g. paclitaxel, docetaxel) chemotherapy in the neo-adjuvant / adjuvant or metastatic setting is preferred, but not required\r\n* Patients with hormone receptor-positive (estrogen and/or progesterone receptor-positive) disease 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; endocrine therapy must have been completed at least  days before study treatment\r\n* Prior radiation is allowed; radiation therapy must have been completed at least  days before study treatment\r\n* Prior treatment with Food and Drug Administration (FDA) approved or investigational biologics (other than PARP inhibitors) and novel molecularly targeted therapies, including oral or IV formulations, shall not exclude patients from participation\r\n* For agents with ambiguous categorization, final determination of patient eligibility will be made by the protocol chair prior to enrollment\r\n* Prior PARP inhibitor use is not allowed for this study
Expansion Cohort B (Ribociclib + PDR + Fulvestrant): Prior hormonal therapy:\r\n* Participants may have received any number of previous endocrine / hormonal lines of therapy in the metastatic setting, as long as the last dose is >=  days prior to first dose of study treatment\r\n* Participants must have progressed on an aromatase inhibitor in the metastatic setting or experienced disease recurrence within  months of completing adjuvant therapy with an aromatase inhibitor\r\n* Treatment with prior fulvestrant is prohibited
Any number of prior lines of therapy are allowed\r\n* Prior platinum based therapy is allowed in the following settings:\r\n** Treatment in the neoadjuvant and/or adjuvant setting without clear progression of disease\r\n** Treatment in the metastatic setting without clear progression of disease
Participants who have received prior treatment with exemestane in the metastatic setting or who have recurred within  months of adjuvant exemestane
SAFETY RUN-IN: Patients received up to  prior regimens for their disease in the metastatic setting
Cohort A:\r\n* Prior treatment with at least one regimen containing trastuzumab and taxane\r\n* No prior treatment with T-DM that was discontinued due to disease progression or toxicity\r\n* No more than  prior lines of therapy in the metastatic setting
Patients must have previous treatment with ado-trastuzumab emtansine (Kadcyla, T-DM) in any setting. Patients must have previously received trastuzumab and pertuzumab in the metastatic setting or within  months of neoadjuvant/adjuvant treatment.
Prior therapy for breast cancer in the advanced/metastatic setting must have included at least:
Part D) Triple-negative disease and received  prior non-hormonally-directed or cytotoxic therapy in the MBC setting; or
No prior systemic therapy in the metastatic or advanced setting
Up to  prior cytotoxic chemotherapeutics regimens or myelosuppressive therapies in the advanced setting.
Prior cetuximab is allowed in the adjuvant but not in the metastatic setting, but must have been completed at least  months before starting this trial
Have received at least  prior lines of anti-HER directed therapy in the metastatic setting, or in case of having received (neo)adjuvant pertuzumab, at least  prior line of anti-HER directed therapy in the metastatic setting. In either case, patients must have received prior treatment with pertuzumab, in the (neo)adjuvant or metastatic setting. Prior radiotherapy, hormonal therapies, and other anti-HER therapies are allowed.
Patients must be immunotherapy-naive. Those who have previously been treated with conventional chemotherapy for a prior history of sarcoma in the adjuvant setting may be included.
Patients who had prior carboplatin in the metastatic setting are not eligible\r\n* Note: Prior carboplatin as neoadjuvant or adjuvant treatment is permitted
Previous treatment with cytotoxic chemotherapy therapy in the recurrent/metastatic setting; previous treatment with non-cytotoxic agents in the recurrent/metastatic setting is permitted
Received one or more prior therapies for TNBC or inflammatory breast cancer in the metastatic setting, and prior treatment (metastatic or (neo) adjuvant) must have included a prior taxane and/or anthracycline-based therapy.
Cetuximab-naive patients may not have received cetuximab therapy in the recurrent/metastatic setting (treatment in curative setting permitted)
Any number of prior systemic treatment regimen in the advanced/metastatic setting is allowed (cytokine, anti-angiogenic, mTOR inhibitor or clinical trial) including previously untreated patients
Prior exposure to a taxane (paclitaxel or docetaxel)-based regimen in localized or advanced/metastatic setting.
Prior therapies:\r\n* Patients must have previously received an aromatase inhibitor in the adjuvant, neo-adjuvant or metastatic setting\r\n* The minimum duration of aromatase inhibitor (AI) in the adjuvant setting is  years\r\n* There is no minimum duration of AI in the metastatic setting or neoadjuvant setting\r\n* Patients may have been previously treated with a CDK / inhibitor or mTOR inhibitor or other investigational agent in addition to an aromatase inhibitor\r\n* Prior treatment with tamoxifen is allowed in the adjuvant setting provided that it was followed by a minimum of  years of an AI
Prior chemotherapy in the adjuvant setting is allowed
Patients must have had =<  prior therapies in the metastatic setting (not including chemotherapy given as maintenance therapy)
Up to  prior cytotoxic chemotreatment regimens in the metastatic setting are allowed; adjuvant chemotreatment will not be considered a prior line of treatment
Prior trastuzumab use in the adjuvant or metastatic setting
Patients must have received at least one, but not more than three, systemic regimens for treatment of metastatic soft tissue sarcoma; patients must have had a prior anthracycline in either the adjuvant or metastatic setting unless medically inappropriate for the patient
Prior radiotherapy in the adjuvant setting allowed provided that less than % of the bone marrow had been irradiated
Subjects who have received prior taxane therapy in the metastatic setting
Prior treatment may include a taxane as per the following criteria:\r\n* Prior taxane (including paclitaxel) in the adjuvant or neoadjuvant setting is allowed, provided that the interval between the completion of (neo)adjuvant therapy and disease recurrence is >  months\r\n* Prior taxane in the metastatic setting is allowed, provided that the agent administered in the metastatic setting was not standard paclitaxel
Received no more than one prior regimen of chemotherapy in the metastatic setting
No prior systemic chemotherapy treatment in the metastatic setting
Patients may have had prior systemic therapy in the adjuvant setting (e.g. interferon, BRAF, or mitogen-activated protein kinase [MEK] agents); patients may have had prior anti-cytotoxic T-lymphocyte antigen  (CTLA-) in the adjuvant setting, if at least one year from last dose of treatment has passed prior to beginning treatment; patients may not have had any prior programmed cell death (PD)-/PD-ligand (PD-L) agent in the adjuvant setting
Patients may not have had a prior anti-angiogenic agent in the recurrent setting; prior use of bevacizumab in the upfront or upfront maintenance setting is allowed
At least one prior systematic therapy in the metastatic setting
Subject has had prior progression on treatment with fulvestrant (prior adjuvant treatment or brief exposure in the advanced setting is allowed)
PRE-MENOPAUSAL ELIGIBILITY: \r\n* Premenopausal women who received adjuvant aromatase inhibitor and ovarian suppression (AI + OS) in the adjuvant setting and completed at least  months of hormonal therapy\r\n* Pre-menopausal women with de novo metastatic disease are eligible if they have had no prior endocrine therapy\r\n* Premenopausal women who have not received tamoxifen in the metastatic setting, but have received up to two lines of chemotherapy
Patient has received tamoxifen in the metastatic setting (for more than  days) or has progressed while on tamoxifen in the adjuvant setting
Study participants must have completed any prior treatment at least  weeks prior to treatment on this protocol; prior treatments may have included chemotherapy however may not have included BRAF or MEK inhibitors or immunotherapies (interleukin-, ipilimumab, anti-programmed death [PD] antibodies etc.) excluding vaccine therapy; prior treatment with interferon in the adjuvant setting is allowed, though prior treatment with ipilimumab in the adjuvant setting is not; prior radiation therapy is allowed though must have included no more than  centigray (cGy) to fields including substantial marrow
Patients may have received any number of prior systemic treatment regimens for distant metastatic disease or advanced regional disease; the following prior therapy is permitted in either the adjuvant or metastatic disease setting:\r\n* No prior therapy\r\n* Immunotherapy consisting of interferon-alpha, interleukin-, GM-CSF, ipilimumab, anti-PD, cancer vaccines, or other experimental agent\r\n* Cytotoxic chemotherapy consisting of dacarbazine, temozolomide, carboplatin, or paclitaxel alone or in combination\r\n* Targeted therapy with temsirolimus, bevacizumab, or sorafenib
Must have received trastuzumab (neoadjuvant, adjuvant or metastatic setting)
Up to four prior chemotherapy regimens and anti-HER agents in the metastatic setting allowed; patients must have progressed on trastuzumab based therapy and must have received ado-trastuzumab emtansine for metastatic breast cancer
Subjects with BRAFV wild-type tumors must not have received any prior systemic anticancer treatment consisting of chemotherapy, immunotherapy, or targeted therapy given in a non-adjuvant setting for unresectable stage IIIB to IVMc melanoma.
Prior exposure to taxane in the adjuvant, neoadjuvant or metastatic setting
At least one prior regimen of chemotherapy in the setting of metastatic breast cancer; no upper limit on the number of prior endocrine regimens for metastatic breast cancer, however no more than  chemotherapeutic regimens may have been given in the metastatic setting
Treatment nave (ie, no prior chemotherapy in the metastatic disease setting and no prior ALK inhibitor therapy allowed).
Disease progression after crizotinib only. No prior chemotherapy is allowed in the metastatic disease setting.
Treatment nave (ie, no prior chemotherapy in the metastatic disease setting and no prior ROS inhibitor therapy).
Prior treatment with a taxane and/or anthracycline in the neoadjuvant, adjuvant, locally advanced, or metastatic setting unless medically contraindicated
must have received a taxane in any disease setting
Previously treated with an anthracycline and/or taxane in the neoadjuvant/adjuvant or metastatic setting
Phase I (Cohorts E and F): Post-menopausal females with locally advanced or metastatic hormone receptor-positive breast cancer that has progressed or failed to respond to at least one prior endocrine therapy in the adjuvant or metastatic setting
Phase I (Cohorts J through S): Post-menopausal females with HER-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
Women must have received ?  prior hormonal treatment(s) in the metastatic or adjuvant setting. If the most recent hormonal treatment was in the metastatic setting, duration of response (tumor regression or stabilization of disease) to this specific course of therapy must be ?  months. If the most recent hormonal treatment was in the adjuvant setting, duration of response (disease free) to this specific course of therapy must be ?  years
No more than  prior chemotherapies in the advanced or metastatic setting
Prior treatment\r\n* No more than two prior chemotherapy regimens in the metastatic setting\r\n* Prior treatment with an aromatase inhibitor (either anastrozole, letrozole or exemestane), either in the adjuvant or metastatic setting is required\r\n* Unlimited prior endocrine regimens in the metastatic setting, which may have included an everolimus or cyclin dependent kinase (CDK) / inhibitor (such as palbociclib, abemaciclib or ribociclib) containing regimen\r\n* Prior tamoxifen treatment is allowed in the adjuvant setting, but patients must not have experienced relapse within  year of stopping tamoxifen\r\n* No prior treatment with tamoxifen in the metastatic setting\r\n* No prior treatment with endoxifen\r\n* Patients who have not fully recovered from acute, reversible effects of prior therapy regardless of interval since last treatment are not eligible to participate in this study\r\n** EXCEPTION: neuropathies-if grade  neuropathies have been stable for at least  months since completion of prior treatment patient is eligible
Prior use of cetuximab in the R/M disease treatment setting (except cetuximab during curative radiotherapy)
Randomized Phase  Dose Expansion - Individuals may have disease progression during treatment or within  months of completion of endocrine therapy (tamoxifen, and/or AI) in the adjuvant setting, or disease progression during treatment with endocrine therapy (tamoxifen, AI or CDK/ inhibitor plus AI) for advanced/metastatic disease. Individuals may have had unlimited prior hormonal therapy, but must be naive to fulvestrant in the metastatic setting. A total of  prior chemotherapies are allowed, however, only one for metastatic disease is permitted.
For Cohort : had prior systemic therapy in the advanced disease setting
Previous treatment with any systemic antineoplastic therapy in the advanced setting (NSCLC stage IIIB or IV. Patients who received only one cycle of antineoplastic therapy in the advanced setting are allowed).
Received more than  prior systemic treatment regimens with chemotherapy , hormonal, or immunotherapy in the metastatic setting or received more than  prior chemotherapeutic regimen in the metastatic setting
In the phase II portion, patients must be newly diagnosed or imatinib treatment naive in the advanced/metastatic setting; prior adjuvant imatinib therapy is allowed as long as disease recurrence was documented >=  days after last dose of imatinib and imatinib has not yet been restarted
No prior use of anthracyclines and taxanes for metastatic disease or in the adjuvant or neoadjuvant setting
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.
Prior systemic fluoropyrimidine therapy (unless given in an adjuvant setting and at least six months earlier); prior topical fluoropyrimidine use is allowed
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 >  months prior to the time of study registration
Patients may have received but may not have progressed on prior anti-angiogenic therapy in the upfront setting
Patient has had prior systemic therapy for MCC\r\n* Note: prior systemic cytotoxic chemotherapy will be allowed if it was administered in the adjuvant setting (no clinically detectable MCC at the time) and treatment concluded more than  months prior to beginning study treatment
Prior treatment with trastuzumab + pertuzumab (HP)-based or pertuzumab-based therapy in the neoadjuvant/adjuvant, unresectable, locally advanced, or metastatic setting
Patients must have had progression on a trastuzumab and/or taxane-based chemotherapy regimen: \r\n* Metastatic patients must have progressed during or after trastuzumab and/or taxane treatment (at any time)\r\n* Locally advanced patients must have progressed within  months after trastuzumab and/or taxane treatment \r\nNote: patients who had prior trastuzumab and/or taxane-based chemotherapy in the adjuvant setting only may still be eligible if, in the opinion of the treating investigator, the patient is not an appropriate candidate to receive trastuzumab/pertuzumab/docetaxel as a first-line regimen for their metastatic disease
Prior therapy with an anthracycline and a taxane in either an adjuvant or metastatic setting.
Histologically confirmed, locally advanced (T primary tumor and stage IIIB or IIIC disease) or metastatic breast cancer that progressed after treatment with standard treatment regimens in the adjuvant or neoadjuvant setting
Patients may have received - prior systemic therapies in the metastatic setting.
May have previously received lapatinib as part of a regimen in the perioperative or metastatic setting with evidence of progression of disease; washout period for lapatinib of  days
Participants must have received prior therapy with the following agents in any combination, and in setting (i.e., neoadjuvant, adjuvant, metastatic, etc.); these therapies do not need to be the most recent line of therapy\r\n* Trastuzumab\r\n* Pertuzumab\r\n* Ado-trastuzumab emtansine (T-DM)
Participants must have had prior trastuzumab therapy (either in the adjuvant or metastatic setting)
Must have had treatment with at least  but no more than  previous regimens in the metastatic setting. Previous treatment must have included an anthracycline and taxane in either the adjuvant or metastatic setting.
Patients should not have been previously treated with cytotoxic drugs and immunotherapeutic agents for unresectable stage III or stage IV disease; prior ipilimumab in metastatic setting is not allowed; prior therapy may include one line of targeted therapy for metastatic disease i.e. v-raf murine sarcoma viral oncogene homolog B (BRAF) or mitogen-activated protein kinase kinase (MEK) inhibitor; at least  weeks should have passed since the last dose of prior adjuvant interferon therapy and prior targeted therapies, and all previous therapy related toxicities should have resolved before starting study treatment; prior adjuvant interferon is permitted; prior cytotoxic therapy in adjuvant or metastatic setting is not allowed; prior ipilimumab in adjuvant setting is not allowed; prior adjuvant therapy with targeted therapy including but not limited to B-RAF, MEK inhibitors etc. is allowed; prior palliative radiation therapy for metastatic melanoma is permitted provided the patient has unirradiated metastatic sites for response evaluation and has fully recovered from its toxicity
Any number of prior endocrine therapies in the metastatic setting are allowed. The patient must not have received any prior chemotherapy agents in the metastatic setting. Prior treatment with adjuvant docetaxel or paclitaxel is allowed if disease relapse occurred greater than  months from the completion of adjuvant therapy.
Received  or  prior anti-angiogenic therapy regimens in advanced or metastatic setting
No more than  total prior systemic treatment regimens in the advanced or metastatic setting, and evidence of progression on or after last treatment regimen received and within  months of enrollment
No prior cytotoxic chemotherapy or targeted therapy in the advanced or metastatic setting; post-operative adjuvant therapy for previously resected NSCLC is allowed as long as the last dose was given greater than  year before study entry, and there is current evidence of disease progression
Prior systemic anti-cancer treatment in the advanced or metastatic setting; prior systemic treatment in the adjuvant setting is allowed
Previous treatment with anti-HER agents for breast cancer, except trastuzumab and/or lapatinib in the neoadjuvant or adjuvant setting
Prior taxane therapy in the adjuvant or metastatic setting is allowed
Chemotherapy or trastuzumab or bevacizumab in the adjuvant setting is allowed but must have been completed at least  weeks prior to study registration; other prior non-hormonal investigational agents in the adjuvant setting must have completed at least  weeks prior to study registration and should be discussed with the study principal investigator (PI)
Prior aromatase inhibitors (e.g. anastrozole, letrozole, exemestane, aminoglutethamide) are allowed in the adjuvant setting
Patients who have received other agents that modulate or downregulate the estrogen receptor (e.g. raloxifene, fulvestrant) in the adjuvant setting are eligible if they were on treatment for at least  months prior to disease progression in the locally advanced or metastatic setting
Prior aromatase inhibitors (e.g. anastrozole, letrozole, exemestane, aminoglutethamide) are allowed in the locally advanced or metastatic setting
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  months and must have discontinued these agents  months prior to study registration
PRIOR THERAPY PHASE I and PHASE I-T:\r\n* Prior chemotherapy for ovarian cancer patients must have included a first-line platinum-based regimen with or without intravenous consolidation chemotherapy\r\n* Breast cancer patients must have recurred post both an Adriamycin- and taxane-containing regimen\r\n* Prior hormonal-based therapy for ovarian, primary peritoneal serous, fallopian tube cancer, or breast cancer is acceptable\r\n* Patients may not have had a prior PAR polymerase (PARP)-inhibitor in the recurrent or metastatic setting; prior treatment with BSI- (iniparib) is allowed\r\n* Patients may not have had a prior anti-angiogenic agent in the recurrent or metastatic setting
Prior erbB- inhibitor other than trastuzumab or lapatinib in the neoadjuvant or adjuvant setting
Prior treatment with vinorelbine for metastatic setting, or prior treatment with any ErbB- targeted agents except trastuzumab (part  only). Up to  subjects with ErbB--overexpressing metastatic breast cancer who have been previously exposed to lapatinib but are not refractory to lapatinib may be enrolled in part .
Patients must have progressed on, or be intolerant to pertuzumab in the LABC/MBC setting or had disease recurrence within  months of pertuzumab treatment in the neoadjuvant or adjuvant setting.
Nave to targeted therapy (e.g., BRAFi, MEKi) for advanced disease; prior immune-based therapy in the adjuvant setting or for advanced disease (e.g. interferon alfa, ipilimumab, anti-programmed cell death protein  [PD-], vaccine) will be allowed if >  weeks from study entry; prior adjuvant treatment with BRAFi or MEKi will not be allowed
Received more than  prior regimens for advanced or metastatic disease (not including hormonal therapy in the metastatic setting or neoadjuvant or adjuvant therapies)
For Phase II, Arms  and , prior cetuximab or other EGFR-targeted antibody therapy is allowed only if administered in the induction setting, or concurrently with radiation in the curative setting, with the last dose of cetuximab administered at least  months prior to starting the study treatment. For Arm , prior cetuximab must have been administered in the curative, recurrent or metastatic disease setting and disease progression documented within  months of the last dose of cetuximab administered in that setting. This regimen (including both platinum and cetuximab) must be the most recent anti-neoplastic treatment regimen administered.
Patients may not have received more than  prior systemic treatment regimens for distant metastatic disease. The following prior therapy is permitted in either the adjuvant or metastatic disease setting, provided treatment is discontinued at least  weeks prior to initiating study treatment:
No more than two prior chemotherapy regimens administered for the treatment of pancreatic cancer in the adjuvant or advanced/metastatic setting
Have received prior chemotherapy in the metastatic castration-resistant setting (prior chemotherapy in the hormone-sensitive setting is allowed provided last dose was at least  months prior to study entry)
Prior taxanes in the neoadjuvant or adjuvant setting with progression occurring within  months of completion of taxane therapy; or any taxanes in the metastatic setting.
More than one prior chemotherapy regimen administered in the metastatic setting.
Not more than  prior regimens in the metastatic setting, including one prior cytotoxic regimen and one prior non-cytotoxic regimen (prior treatment with adjuvant therapy within  months of recurrence is considered a treatment regimen in the metastatic setting).
Patients may not have received more than two prior systemic treatment regimens for distant metastatic disease; the following prior therapy is permitted in either the adjuvant or metastatic disease setting:\r\n* No prior therapy\r\n* Immunotherapy consisting of interferon, interleukin-, filgrastim (GM-CSF), ipilimumab, anti-programmed death (PD) or other experimental agent\r\n* Cytotoxic chemotherapy consisting of dacarbazine, temozolomide, carboplatin +/- paclitaxel
Previous approved or investigative anti-HER agents in any breast cancer treatment setting, except trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
Part I: Postmenopausal women with locally ABC or MBC whose disease relapsed during treatment with (or within  months after discontinuation of) an AI in the adjuvant setting or progressed during treatment with an AI in the metastatic setting.
The participant has received more than  prior regimens of systemic therapy in the metastatic setting
Patients undergoing RC and IC formation in an elective setting for non-metastatic cancer
Patients must have at least  standard treatment regimen in the advanced, recurrent or metastatic setting
Have received prior chemotherapy in the metastatic castration-resistant setting (prior chemotherapy in the hormone-sensitive setting is allowed provided last dose was at least  months prior to study entry)
Prior treatment of pancreatic cancer in the metastatic setting (or locally advanced setting) with surgery (placement of stent is allowed), radiotherapy, chemotherapy or investigational therapy
Receiving concurrent chemoradiotherapy/chemobiotherapy to a minimum dose equivalent to  Gy in  fractions in the adjuvant or definitive setting
Subjects must have experienced recurrent/progressive disease following treatment with a non-steroidal aromatase inhibitor (letrozole or anastrozole) in an adjuvant or metastatic setting
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-HER 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)
Patients with adenocarcinoma arising from the esophagus, gastroesophageal junction, or stomach must also meet the following criteria: a. Must have received prior treatment with a platinum/fluoropyrimidine-based therapy with or without an anthracycline in the metastatic setting; or, in the adjuvant setting if recurrence occurred within  months of completing systemic adjuvant treatment; b. Patients with HER positive tumors must have had prior treatment with a Her inhibitor (e.g. trastuzumab or lapatinib); c. Patients who have received prior taxane therapy may be enrolled.
Prior therapy with an anthracycline-containing regimen in the neoadjuvant, adjuvant, or metastatic setting, where indicated by local regulation or Investigator judgment.
Prior treatment with a taxane in the metastatic setting
No prior treatment with carboplatin in the metastatic setting; carboplatin in neoadjuvant/adjuvant setting may be allowed if prior treatment with carboplatin was completed at least one year prior to initiation of this study and after discussion with the study chair
For adjuvant setting patients: Metastatic Disease (M+) prior to surgery
For salvage setting patients: Metastatic Disease at PSA rise
For adjuvant setting patients, any treatment received after surgery
No more than  total prior systemic treatment regimens in the advanced or metastatic setting
Prior treatment must include an anthracycline and/or a taxane in the neoadjuvant, adjuvant, or metastatic setting with the exception for participants who are clinically contraindicated for these chemotherapies.