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Platinum Based Chemotherapy or Capecitabine in Treating Patients with Residual Triple-Negative Basal-Like Breast Cancer following Neoadjuvant Chemotherapy

This randomized phase III trial studies how well cisplatin or carboplatin (platinum based chemotherapy) works compared to capecitabine in treating patients with remaining (residual) basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant). Drugs used in chemotherapy, such as cisplatin, carboplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether cisplatin or carboplatin is more effective than capecitabine in treating patients with residual triple negative basal-like breast cancer.
Breast
Phase III
Adults
Chemotherapy - cytotoxic, Therapy (NOS)
Capecitabine, Carboplatin, Cisplatin
Mayer, Ingrid
National
Vanderbilt University
09-24-2015
Treatment
ECOGBREEA1131
NCT02445391

Eligibility

18 Years
BOTH
NO
Inclusion Criteria:

ELIGIBILITY CRITERIA FOR SCREENING AND MOLECULAR PROFILING (STEP 0)

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 2 weeks prior to screening

Female and male patients must have histologically confirmed invasive breast cancer that meets the following criteria: * Clinical stage II-III (American Joint Committee on Cancer [AJCC] 8th edition) at diagnosis, based on initial evaluation by clinical examination and/or breast imaging; no metastatic disease allowed * ER- and PR- should meet one of the following criteria: ** =
Patients must have completed neoadjuvant taxane +/- anthracycline; patients must NOT have received cisplatin or carboplatin or capecitabine as part of their neoadjuvant therapy regimen * NOTE: Patients who received preoperative therapy as part of a clinical trial may enroll * NOTE: Patients that were not able to complete their planned neoadjuvant chemotherapy for any reason (i.e. toxicities, etc.) are eligible to participate as long as no further systemic standard of care therapy is planned by the treating physician

Must have completed definitive resection of primary tumor * Negative margins for both invasive and ductal carcinoma in situ (DCIS) are desirable, however patients with positive margins may enroll if the treatment team believes no further surgery is possible and patient has received radiotherapy; patients with margins positive for lobular carcinoma in situ (LCIS) are eligible * Either mastectomy or breast conserving surgery (including lumpectomy or partial mastectomy) is acceptable * Sentinel node biopsy either pre or post neoadjuvant chemotherapy (i.e. at the time of definitive surgery) are allowed; axillary dissection is encouraged in patients with lymph node involvement, but is not mandatory

Post neoadjuvant chemotherapy, patients must be found to have residual invasive cancer in the breast at the time of definitive surgery; residual cancer is defined as a contiguous focus of residual invasive cancer, in the breast, measuring >= 1 cm in diameter, and with more than minimal cellularity, as per local pathologist determination; please note that in patients that have multifocal or multicentric residual tumors these lesions cannot be added up; the biggest lesion has to measure >= 1 cm in diameter; this is required due to constraints in deoxyribonucleic acid (DNA) extraction for PAM50 analysis * NOTE: The presence of ductal carcinoma in situ (DCIS) without invasion does not qualify as residual invasive disease in the breast * NOTE: Despite lymph node involvement if residual invasive cancer in the breast is
Radiotherapy may be given before or after protocol treatment per standard of care guidelines; when radiotherapy is planned prior to protocol treatment administration, patients may be registered and screened while receiving radiation * Post-mastectomy radiotherapy is required for all patients with the following: ** Primary tumor >= 5 cm (prior to neoadjuvant chemotherapy [clinically] or at the time of definitive surgery) or involvement of lymph nodes at the time of definitive surgery ** For patients with primary tumors
Hemoglobin (Hgb) > 9.0 g/dL (must be obtained within 8 weeks prior to screening for protocol therapy)

Platelets > 100,000 mm^3 (must be obtained within 8 weeks prior to screening for protocol therapy)

Absolute neutrophil count (ANC) > 1500 mm^3 (must be obtained within 8 weeks prior to screening for protocol therapy)

Calculated creatinine clearance of > 50 mL/min using the Cockcroft-Gault formula (must be obtained within 8 weeks prior to screening for protocol therapy)

Bilirubin =
Aspartate aminotransferase (AST, serum glutamic oxaloacetic transaminase [SGOT]) =
Alanine aminotransferase (ALT, serum glutamate pyruvate transaminase [SGPT]) =
No history of TNBC invasive breast cancer within 5 years of enrollment, no concurrent malignancies of any sort

No clinically significant infections as judged by the treating investigator

Patients with active >= Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4 grade 2 neuropathy are ineligible

Adjuvant chemotherapy after surgery other than that specified in this protocol is not allowed; luteinizing hormone-releasing hormone (LHRH) agonists and adjuvant bisphosphonate or denosumab use is allowed

Patients must have archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen from the residual disease on the definitive surgical specimen available for PAM50 analysis for stratification * Tumor tissue specimen from the definitive surgery has been collected and is ready to ship to the ECOG-American College of Radiology Imaging Network (ACRIN) Central Biorepository and Pathology Facility (CBPF) within 21 weeks post-surgery * The Molecular Diagnostics Laboratory (MDL) at MD Anderson Cancer Center will perform the PAM50 analysis and notify the ECOG-American College of Radiology Imaging Network (ACRIN) operations office within three (3) weeks of receipt of the tumor tissue specimen via secure electronic messaging to the ECOG-ACRIN database; results will not be reported to the submitting institution * NOTE: Tissue must and can be submitted any time during screening period, even if patient is getting radiation * NOTE: Every effort should be made to submit the tumor tissue specimen to the ECOG-ACRIN CBPF immediately

ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): No specific timeframe between registration and randomization needs to be observed, as long as: * Patients randomized to the chemotherapy arms have their cycle 1/ day 1 (platinum based or capecitabine) start within 3 weeks (15 working days) following randomization date * Randomization occurs no more than 24 weeks from surgery date

ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Must have PAM50 analysis by digital mRNA quantitation on the formalin-fixed paraffin-embedded tumor tissue specimen (FFPE) of the residual disease in the breast resected at the time of definitive surgery completed

ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): ECOG performance status 0 or 1 within 2 weeks prior to randomization

ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Radiotherapy may be given before or after protocol treatment. when radiotherapy is planned prior to protocol treatment administration, patients must have completed adjuvant radiotherapy >= 2 weeks prior to randomization for protocol therapy, if applicable

ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Patients must have completed treatment with any investigational agent >= 30 days prior to randomization for protocol therapy, if applicable

ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Patients must be randomized within 24 weeks from surgery

ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Women must not be pregnant or breast-feeding due to risk of teratogenicity/ toxicity with capecitabine or platinum-based therapy; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy * A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months

ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study

ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Hemoglobin (Hgb) > 9.0 g/dL (must be obtained within 2 weeks prior to randomization)

ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Platelets > 100,000 mm^3 (must be obtained within 2 weeks prior to randomization)

ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Absolute neutrophil count (ANC) > 1500 mm^3 (must be obtained within 2 weeks prior to randomization)

ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): International normalized ratio (INR) =
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Calculated creatinine clearance of > 50 mL/min using the Cockcroft-Gault formula (must be obtained within 2 weeks prior to randomization)

ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Bilirubin =
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Aspartate aminotransferase (AST, SGOT) =
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Alanine aminotransferase (ALT, SGPT) =

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