Conditions: Breast Cancer
Keywords: Triple negative (ER/PR negative; HER2 negative)
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 30
Healthy volunteers: no

Brief summary:
This neoadjuvant chemotherapy protocol focusing on "triple-negative" breast cancers alone will gather a foundation of primary tumor and axillary lymph nodal response to primary chemotherapy and ongoing correlated disease-free (DFS) and overall survival (OS) outcome data. This comparative data can then be used in building subsequent trials.

Detailed description:
Women with a diagnosed "triple-negative" proxy of basal-like breast cancer confirmed on a core biopsy and larger than 2 cm will be treated neoadjuvantly with the Livingston metronomic regimen of 12 weeks of weekly doxorubicin 24 mg/m2 and daily oral cyclophosphamide 60 mg/m2 followed by 12 successive weeks of taxol 80 mg/m2 and carboplatin AUC 2. Although clinical response will be evaluated prior to surgery, the primary end-point is the pathologic response. Secondary end-points will be DFS and OS based upon standard of care surveillance. A pathologic complete response (pCR) will require no histologic evidence of residual malignant cells seen in the primary tumor area specimen or the lymph nodes. Standard of care surgery and radiation therapy will be undertaken.

Arms:
arm 1: Neoadjuvant chemotherapy with metronomic AC followed by weekly TC then surgery

Interventions: intervention 1: Doxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin intervention 2: Definitive Surgery intervention 3: Radiotherapy
Intervention descriptions: intervention 1: DOXORUBICIN 24mg/m2 IV plus CYCLOPHOSPHAMIDE 60mg/m2 PO weekly x 12 successive weeks followed by PACLITAXEL 80mg/m2 IV over 1 hour plus CARBOPLATIN AUC 2 IV weekly x 12 successive weeks intervention 2: Standard of care definitive surgery as determined by medical provider intervention 3: Standard of care RADIATION THERAPY as indicated

Protocol document: