Conditions: Breast Cancer HER2-negative Breast Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 50
Healthy volunteers: no

Brief summary:
NSABP FB-9 is a Phase II, multi-center, randomized study of eribulin or weekly paclitaxel followed by doxorubicin and cyclophosphamide (AC) as neoadjuvant therapy for women with HER2-negative, operable and locally advanced breast cancer (stage IIb and III). Patients in the control arm will receive neoadjuvant weekly paclitaxel (WP) followed by AC. The primary aim of the study is to determine the pathologic complete response (ypCR) in breast and axillary lymph nodes following completion of neoadjuvant therapy. The secondary aims include determination of the ypCR in axillary nodes, clinical complete response (ycCR) rate after eribulin or paclitaxel and after completion of neoadjuvant chemotherapy, two-year recurrence-free interval, two-year overall survival, and toxicity of the neoadjuvant regimens.

Detailed description:
Patients will be randomized to one of two neoadjuvant therapy regimens. Patients in Arm 1 will receive WP 80 mg/m2 for 12 doses followed by standard AC every 21 days for 4 cycles. Patients in Arm 2 will receive 4 cycles of eribulin 1.4 mg/m2 on days 1 and 8 of a 21-day cycle followed by standard AC every 21 days for 4 cycles. As soon as possible following recovery from chemotherapy, the patient will have either lumpectomy or mastectomy and axillary staging.

In both arms, clinical response will be assessed by physical exam on day 1 of each study therapy cycle. MRI of the breast is required within 4 weeks prior to randomization and following completion of eribulin or WP (before starting AC). Following recovery from surgery, patients will receive radiation therapy and hormonal therapy as clinically indicated. Other postoperative therapies are prohibited.

Patients will be randomized to the control arm (Arm 1) and to the investigational arm (Arm 2) in a 1:2 ratio. The sample size will be up to 50 patients with about 30 patients in Arm 2 and about half that number in Arm 1. Accrual is expected to occur over 15 months.

Arms:
arm 1: Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles arm 2: Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles

Interventions: intervention 1: Paclitaxel intervention 2: Eribulin intervention 3: Doxorubicin intervention 4: Cyclophosphamide
Intervention descriptions: intervention 1: 80 mg/m2 IV over 60 minutes weekly for 12 weeks intervention 2: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles intervention 3: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles intervention 4: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles

Protocol document: