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

• Status: Terminated
• Trial end date: 2016-08-02
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leo W. Jenkins Cancer Center
• Treatments: Carboplatin; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Paclitaxel

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