A Phase II Randomized Clinical Trial Evaluating Neoadjuvant Chemotherapy Regimens With Weekly Paclitaxel or Eribulin Followed by Doxorubicin and Cyclophosphamide in Women With Locally Advanced HER2-Negative Breast Cancer

Status
Active
Cancer Type
Breast Cancer
Trial Phase
Phase II
Eligibility
18 and over, Female
Study Type
Treatment
NCD ID
NCT01705691
Protocol IDs
NSABP FB-9 (primary)
Study Sponsor
National Surgical Adjuvant Breast and Bowel Project

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.

Objectives

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.