Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer

• 1) Pathologic response [ Time Frame: within 3 weeks of completing neoadjuvant chemotherapy ] [ Designated as safety issue: No ]
  

• 1) Clinical response 2) Disease free survival (DFS) 3) Overall Survival (OS) [ Time Frame: Ongoing clinical surveillance follow-up assessing Disease Free and Overall Survival ] [ Designated as safety issue: No ]
  

Drug: Doxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin
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
Procedure: Definitive Surgery
Standard of care definitive surgery as determined by medical provider
Radiation: Radiotherapy
Standard of care RADIATION THERAPY as indicated

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.