Spots Global Cancer Trial Database for Comparison of Neoadjuvant Chemotherapy With Weekly Paclitaxel or Eribulin Followed by A/C in Women With Locally Advanced HER2-Negative Breast Cancer
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Trial Identification
Brief Title: Comparison of Neoadjuvant Chemotherapy With Weekly Paclitaxel or Eribulin Followed by A/C in Women With Locally Advanced HER2-Negative Breast Cancer
Official Title: 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
Study ID: NCT01705691
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
CCOP, Colorado Cancer Research Program, Inc., Denver, Colorado, United States
CCOP - Mount Sinai Medical Center, Miami Beach, Florida, United States
Phoebe Putney Memorial Hospital, Albany, Georgia, United States
Memorial Health University Medical Center, Savannah, Georgia, United States
Henry Ford Health System, Detroit, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Providence Hospital - Southfield, Southfield, Michigan, United States
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Carolinas Medical Center/Levine Cancer Center, Charlotte, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Albert Einstein Medical Center, Philadelphia, Pennsylvania, United States
Allegheny General Hospital/Allegheny-Singer Research Institute, Pittsburgh, Pennsylvania, United States
NSABP Foundation, Inc., Pittsburgh, Pennsylvania, United States
University of Pittsburgh, Pittsburgh, Pennsylvania, United States
Roper Hospital, Charleston, South Carolina, United States
Cancer Centers of the Carolinas, Greenville, South Carolina, United States
Joe Arrington Cancer Research & Treatment Center, Lubbock, Texas, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals, Morgantown, West Virginia, United States
Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada
Montreal General Hospital, Montreal, Quebec, Canada
Contact Details
Name: Norman Wolmark, MD
Affiliation: NSABP Foundation Inc
Role: PRINCIPAL_INVESTIGATOR
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