|Principal Investigator/ Physician||Carole Norden, MD|
|Sponsor||Eastern Cooperative Oncology Group|
|Contact Email||MCI Clinical Trials|
Protocol Tiltle: "A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Capecitabine in Patients with Residual Triple-Negative Basal-Like Breast Cancer following Neoadjuvant Chemotherapy."
Inclusion Criteria: ECOG performance status 0 or 1 within 2 weeks prior to screening, Female and male patients must have histologically confirmed triple negative (estrogen receptor negative [ER-]/progesterone receptor negative [PR-]/human epidermal growth factor receptor-2 negative [HER2-]) invasive breast cancer, clinical stage II-III at diagnosis (American Joint Committee on Cancer [AJCC] 7th edition) based on initial evaluation by clinical examination and/or breast imaging, Patients must have completed neoadjuvant taxane +/- anthracycline; patients must NOT have received cisplatin or carboplatin or capecitabine as part of their neoadjuvant therapy regimen, Must have completed definitive resection of primary tumor, 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, Post-mastectomy radiotherapy is required for all patients with: Primary tumor >= 5 cm (prior to neoadjuvant chemotherapy [clinically] or at the time of definitive surgery) or involvement of 4 or more lymph nodes at the time of definitive surgery & or patients with primary tumors < 5 cm or with < 4 involved lymph nodes prior to neoadjuvant chemotherapy and at the time of definitive surgery, provision of post-mastectomy radiotherapy is at the discretion of the treating physician, Breast radiotherapy (whole breast or partial) is required for patients who underwent breast-conserving therapy, including lumpectomy or partial mastectomy, Laboratory values must be obtained within 8 weeks prior to screening for protocol therapy, Hemoglobin (Hgb) > 9.0 g/dL, Platelets > 100 mm^3, Absolute neutrophil count (ANC) > 1500 mm^3, Calculated creatinine clearance of > 50 mL/min using the Cockcroft-Gault formula, Bilirubin =< 1.5 x ULN upper limit of normal (except in patients with documented Gilbert's disease, who must have a total bilirubin =< 3.0 mg/dL), Aspartate aminotransferase (AST, serum glutamic oxaloacetic transaminase [SGOT]) =< 2.5 x upper limit of normal (ULN), Alanine aminotransferase (ALT, serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN, No stage IV (metastatic) disease, however no specific staging studies are required in the absence of symptoms or physical exam findings that would suggest distant disease, 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.
Clinical Trails.Gov Link: https://clinicaltrials.gov/ct2/show/NCT02445391?term=EA1131&rank=1
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