[c09aa8]: / clusters / ordered9kclusters / clust_401.txt

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Pathologically confirmed metastatic breast cancer
No prior systemic treatment for metastatic breast cancer
Metastatic breast cancer (measurable or evaluable including bone metastases only)
Any number of prior therapies for metastatic breast cancer is allowed; patients with weakly estrogen receptor positive breast cancer who received any number of endocrine agents for metastatic breast cancer will also be eligible
Metastatic non-gynecologic or breast primaries
No prior chemotherapy or trastuzumab for treatment of metastatic breast cancer
Stage 4 (metastatic) breast cancer
Metastatic non-small cell lung cancer (NSCLC), metastatic urothelial carcinoma or microsatellite instability high metastatic colorectal cancer (except for patients enrolling based on elevated TMB); For patients enrolling based on elevated TMB, patients with metastatic NSCLC, metastatic urothelial carcinoma or metastatic colorectal cancer will be allowed to enroll
Prior therapies for metastatic breast cancer\r\n* Frontline patients who have not received prior systemic therapy for metastatic breast cancer are eligible, \r\n* Patients who have received =< 2 prior chemotherapy regimens for metastatic breast cancer are eligible
Metastatic melanoma, gastrointestinal, or genitourinary cancer with at least one lesion that is resectable; only patients with metastatic gastrointestinal cancer will be eligible for enrollment on the phase I portion of the study; patients with metastatic melanoma, gastrointestinal, or genitourinary cancer will be eligible for enrollment on the phase II portion of the study
Women with metastatic breast cancer who are eligible for capecitabine monotherapy; for HER2 positive breast cancer, concurrent trastuzumab is allowed OR
Patients (both male and female) with advanced/metastatic GI cancers eligible for capecitabine monotherapy, including metastatic colorectal cancer, metastatic gastric and esophageal cancers, and unresectable or metastatic pancreatic cancer and cholangiocarcinoma, including gall bladder carcinoma, concurrent trastuzumab is allowed for HER2 positive gastric/esophageal cancer
Patients with metastatic breast cancer
At least one prior line of therapy for metastatic breast cancer
Patients who had received therapy for metastatic breast cancer (other than that described above)
Patients with new or progressive breast cancer metastatic to brain will be eligible provided:
Metastatic (stage IV) triple negative breast cancer that has progressed after at least one prior chemotherapy regimen in the metastatic setting; non-measurable disease (i.e. bone metastases) is permitted
Stage I-III non-metastatic breast cancer\r\n* Inflammatory breast cancer (T4d) is acceptable\r\n* Patients with oligo-metastatic disease who are being treated with a curative intent as per the treating physician are eligible as well
gBRCAm HER2-negative metastatic breast cancer (module 2)
Patients with histologically confirmed metastatic melanoma, metastatic non-small cell lung cancer, metastatic breast cancer, or metastatic pancreatic adenocarcinoma relapsed or refractory to therapy as outlined below or patients with these malignancies who have declined, are or have become unable to tolerate (e.g. progressive chemotherapy-associated peripheral neuropathy), or were not eligible for standard therapy\r\n* Metastatic melanoma patients at any line of therapy\r\n* Metastatic non-small cell lung cancer patients who have relapsed or are refractory to at least one line of systemic anti-cancer therapy for metastatic disease, including cytotoxic chemotherapy or targeted therapy\r\n* Metastatic breast cancer patients who have relapsed or are refractory to at least one line of systemic anti-cancer therapy for metastatic disease, such as cytotoxic chemotherapy, hormonal therapy, or targeted therapy\r\n* Metastatic pancreatic adenocarcinoma who have relapsed or are refractory to at least one line of systemic anti-cancer therapy for metastatic disease, such as cytotoxic chemotherapy or targeted therapy
Metastatic breast cancer
Evidence of metastatic/stage 4 breast cancer
Must have progressed on at least 1 prior systemic therapy regimen for the treatment of advanced breast or other non-breast metastatic cancer; there is no upper limit on the number of prior therapies
Patients must have either A) histologic documentation of metastatic or locally advanced breast cancer by core needle or incisional biopsy, or B) history of breast cancer with radiologic evidence of bone-only metastatic disease
There must be documentation that the patient has evidence of measurable metastatic breast cancer. Histologic confirmation of metastatic disease is not required.
Metastatic or locoregionally recurrent HER2-negative breast cancer; resectable disease allowed
Patient has metastatic breast cancer that is not suitable for surgery or radiation therapy for local disease control at the time of screening.
Patients planned for pre-operative chemotherapy or those with known metastatic breast cancer
Subject has received more than 1 prior line of chemotherapy treatment for metastatic breast cancer
All patients must have recurrent or metastatic HER2-positive breast cancer; diagnosed by biopsy
Patients who have received prior lapatinib for metastatic breast cancer will be excluded
Prior treatment with at least two (2) HER2-directed regimens for metastatic breast cancer.
Received prior trastuzumab or chemotherapy for metastatic breast cancer except if patient has CNS as only site of metastatic disease
Received either one or two prior systemic treatments for metastatic breast cancer and have documented disease progression on or after the most recent therapy
Metastatic Breast Cancer: Human Epidermal Growth Factor Receptor 2 - negative (HER2(-)) recurrent Metastatic Breast Cancer:
Proven diagnosis of metastatic breast cancer (MBC).
Patients with chemotherapy for metastatic disease (patients with 0-3 prior lines of chemotherapy for metastatic breast cancer [MBC])
Prior treatment with greater than (>) 1 cytotoxic chemotherapy regimen for metastatic breast cancer
Metastatic breast cancer patients currently on hormonal therapy as first- or second-line are not permitted
Are currently receiving or have previously received chemotherapy for locoregionally recurrent or metastatic breast cancer
Subjects with more than 2 events of disease progression after the development of metastatic breast cancer.
Patients with metastatic breast cancer
Patients with documented HER2-positive metastatic disease are not eligible, even if their primary breast cancer was HER2-negative
Biopsy proven breast carcinoma which is persistent and metastatic or recurrent and metastatic.
Participants must have histologically confirmed invasive breast cancer that is metastatic or unresectable locally advanced; histological documentation of metastatic/recurrent breast cancer is not required if there is unequivocal evidence for recurrence of the breast cancer
Evidence of metastatic breast cancer
Progression on at least 2 lines of anti-HER2-targeted therapies for metastatic breast cancer (MBC)
Patients with metastatic cancer
Men with metastatic or unresectable breast cancer are eligible
More than 2 prior lines of chemotherapy for metastatic breast cancer.
HER2+ metastatic breast cancer, documented as HER2+ by FISH and/or 3+ staining by immunohistochemistry.
Patients must have had exposure to at least 1 and no more than 3 prior chemotherapy regimens for the treatment of metastatic breast cancer
Patients must not have evidence of metastatic tumor or other cancer
No prior treatment for metastatic breast cancer
Patients who have received prior hormonal or any other systemic therapy for metastatic breast cancer.
Participants must have histologically confirmed invasive breast cancer that is metastatic or unresectable locally advanced; histological documentation of metastatic/recurrent breast cancer is not required if there is unequivocal evidence for recurrence of the breast cancer
Patients with breast cancer must have had at least one prior chemotherapy regimen for metastatic disease; additionally, patients with breast cancer must have received prior tamoxifen and/or aromatase inhibitor therapy (if post-menopausal) with at least one hormonal regimen in the metastatic setting; patients with HER2+ breast cancer must have progressed after at least one prior HER2-directed regimen (trastuzumab, lapatinib) for metastatic disease\r\n* All other patients must have disease that has progressed following at least one line of standard therapy; prior therapy with tamoxifen is allowed
Evidence of metastatic breast cancer following a standard tumor staging work-up
Patients must have histologically proven breast cancer with metastatic disease to the brain
Patients with metastatic breast cancer
Metastatic cervical or uterine cancer.
Histologically verified breast cancer with distant metastases (metastatic breast cancer)
Hormone-refractory metastatic breast cancer defined as disease progression within 6 months from starting most recent hormonal therapy
Patients with current local, loco-regional relapse and/or distant metastatic breast cancer
Metastatic cancer
Diagnosed with metastatic breast cancer, caregiver to patient with metastatic breast cancer (MBC) who is enrolled in this study, or MBC provider
Have metastatic cancer
Patients with metastatic breast cancer
Metastatic breast cancer
Patients with metastatic breast cancer are not eligible to participate
Histologically confirmed breast cancer and no evidence of metastatic disease with a recommendation to begin chemotherapy within 4 weeks
Patients with metastatic cancer or a second primary cancer
Active cancer/metastatic cancer
Patients with metastatic breast cancer
Metastatic breast or other cancer
Metastatic breast or other cancer
Have been diagnosed with non-metastatic breast cancer (stages 0-III)
Prior history or evidence of metastatic breast cancer
Prior history or evidence of metastatic breast cancer
More than one metastatic cancer active in the last 5 years
Patients must already be known to have metastatic, incurable cancer
Inclusion Criteria:\n\n Cisplatin Combination Expansion:\n\n Arm 1:Patients with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic\n setting; Arm 2: Patients with TNBC and one or two prior cytotoxic therapies in the\n metastatic setting.\n\n - Arm A: castrate resistant prostate cancer, advanced breast cancer, or non-small cell\n lunch cancer that are candidates for treatment with a docetaxel-based combination.\n\n - Arm B: Urothelial transitional cell cancer, triple negative breast cancer, ovarian\n cancer or non small cell lunch cancer that are candidates for a cisplatin-based\n combination.\n\n - Arm C: Her2+ breast cancer refractory to prior herceptin or lapatinib, her2+\n esophagal-gastric cancer, head and neck squamous cell cancer, or non small cell lunch\n cancer that are candidates for treatment with a dacomitinib-based combination.\n\n - Availability of archival tumor biopsy sample or willing to provide fresh biopsy if not\n available.\n\n - Eastern Cooperative Oncology Group [ECOG] performance must be 0 or 1.\n\n - Adequate bone marrow, renal and liver function.\n\n Exclusion Criteria:\n\n - Prior therapy for Cisplatin Combination Expansion:\n\n - Prior platinum (carboplatin or cisplatin) in either the adjuvant or metastatic\n setting;\n\n - Prior radiation to >25% bone marrow as estimated by the Investigator.\n\n - Patients with known symptomatic brain metastases.\n\n - Chemotherapy, radiotherapy, biologics or investigational agent within 4 weeks of the\n lead-in dose.\n\n - Major surgery within 4 weeks of the baseline disease assessments.\n\n - >2 prior regimens containing cytotoxic chemotherapy in the metastatic setting.\n\n - Active bacterial, fungal or viral infection.\n\n - Uncontrolled or significant cardiovascular disease.
Diagnosed with non-metastatic (i.e., stages I – III) cancer
No prior treatment with chemotherapy for a diagnosis of locoregionally recurrent or metastatic breast cancer is allowed.
Patients have either metastatic or non-metastatic lung cancer as defined in history and physical
Histopathologically confirmed metastatic breast cancer