Spots Global Cancer Trial Database for Maintenance Treatment With Eribulin Mesylate Versus Observation in Triple Negative Breast Cancer Patients
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Trial Identification
Brief Title: Maintenance Treatment With Eribulin Mesylate Versus Observation in Triple Negative Breast Cancer Patients
Official Title: A Multicenter, Randomized, Open-Label, Phase II Study to Evaluate the Efficacy and Safety of Maintenance Treatment With Eribulin Mesylate Following Standard Adjuvant Chemotherapy in Triple Negative Breast Cancer Patients
Study ID: NCT04502680
Conditions
Interventions
Study Description
Brief Summary: This clinical trial is a multicenter, randomized, open-label, phase-II study to evaluate the efficacy and safety of maintenance treatment with eribulin mesylate following standard adjuvant chemotherapy in triple negative breast cancer patients.
Detailed Description: Triple negative breast cancer (TNBC) is an aggressive disease with high relapse rates and poor overall survival. This study explores the role of maintenance treatment with eribulin following standard adjuvant chemotherapy in TNBC. Patients will be randomized to receive eribulin mesylate maintenance treatment or observation after standard adjuvant chemotherapy. The primary objective is to evaluate the disease free survival (DFS). The secondary objective is to evaluate the overall survival (OS), objective response rate (ORR) and the safety of eribulin mesylate maintenance treatment.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Jiangsu Provincial Hospital, Nanjing, Jiangsu, China
Contact Details
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