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Brief Title: Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy
Official Title: Phase II Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy
Study ID: NCT01401959
Brief Summary: The investigators propose to evaluate eribulin as adjuvant therapy in breast cancer patients who have residual invasive disease in breast or lymph node tissue following standard neoadjuvant chemotherapy and surgery regimen. Three cohorts of patients will be evaluated separately based on tumor type: triple-negative, hormone-receptor-positive/HER2-negative, and HER2-positive breast cancers.
Detailed Description: This is a non-randomized, open-label trial to evaluate 6 cycles of eribulin in female patients with invasive breast cancer who do not achieve pathologic complete response (pCR) after treatment with a standard neoadjuvant chemotherapy and surgery regimen. Patients will be randomized into three cohorts according to tumor-type: triple-negative (Cohort A), hormone-receptor-positive/HER2-negative (Cohort B), and HER2-positive (Cohort C) tumors. Patients will receive eribulin for 6 cycles (1 cycle = 21 days). Patients with HER2-positive tumors will also receive trastuzumab. Patients in all cohorts will be allowed to receive locoregional radiotherapy and/or adjuvant hormonal therapy per institutional guidelines.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Florida Cancer Specialists North, Fort Myers, Florida, United States
Florida Cancer Specialists South, Fort Myers, Florida, United States
Watson Clinic Center for Cancer Care and Research, Lakeland, Florida, United States
Florida Hospital Cancer Insitute, Orlando, Florida, United States
Northeast Georgia Medical Center, Gainesville, Georgia, United States
Providence Medical Group, Terre Haute, Indiana, United States
Mercy Hospital, Portland, Maine, United States
Center for Cancer and Blood Disorders, Bethesda, Maryland, United States
National Capital Clinical Research Consortium, Bethesda, Maryland, United States
Nebraska Methodist Cancer Center, Omaha, Nebraska, United States
Atlantic Health System, Morristown, New Jersey, United States
Hematology Oncology Associates of Northern NJ, Morristown, New Jersey, United States
Oncology Hematology Care, Inc., Cincinnati, Ohio, United States
South Carolina Oncology Associates, Columbia, South Carolina, United States
Chattanooga Oncology Hematology Associates, Chattanooga, Tennessee, United States
Tennessee Oncology, Nashville, Tennessee, United States
Texas Health Physician Group, Arlington, Texas, United States
The Center for Cancer and Blood Disorders, Fort Worth, Texas, United States
Name: Denise A Yardley, M.D.
Affiliation: SCRI Development Innovations, LLC
Role: STUDY_CHAIR