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Spots Global Cancer Trial Database for Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy

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Trial Identification

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

Interventions

Eribulin
Trastuzumab

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Denise A Yardley, M.D.

Affiliation: SCRI Development Innovations, LLC

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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