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

Launched by LEO W. JENKINS CANCER CENTER · Oct 9, 2007

Keywords

ClinConnect Summary

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 ...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women with Estrogen Receptor (ER), Progesterone Receptor (PR),and HER2 negative invasive breast cancer confirmed on core biopsy.(Note: HER2 negative by FISH preferred; HER2 0 or 1+ by IHC acceptable)
• • Primary tumor size 2cm or greater by physical exam or radiographic measurements.(Note: Locally advanced T4 or inflammatory breast cancer is eligible.)
• • Assessment of pre-treatment axillary lymph nodal status (Note: FNA biopsy if palpable or sentinel lymph node biopsy (SLNB) if not palpable preferred; clinical exam acceptable.)
• • Absolute neutrophil count \> 1500 mm3 and platelet count \> 100,000 mm3
• • Normal myocardial left ventricular function
• • Serum creatinine \< 2.0 mg/dl
• • Total bilirubin and AST \< 3X upper limits normal
• Exclusion Criteria:
• • Recurrent or metastatic breast cancer findings (Note: If oncologically felt to be a second breast primary, patient eligible for this protocol)
• • Another active cancer present
• • Medical contraindications to chemotherapy or surgery
• • First trimester pregnancy
• • Breast feeding