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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Eribulin mesylate 1.4mg/m2, administered intravenously on Days 1 and 8 of each 21 day cycle.
Jiangsu Provincial Hospital
Nanjing, Jiangsu, China
Disease Free Survival (DFS)
DFS was measured from the date of randomization assignment in the intent to treat (ITT) population to loco-regional or distant recurrence, second primary malignancy or death date, whichever occurred first.
Time frame: 3 years
Overall Survival
OS is defined as time to death from any cause.
Time frame: 3 years
Objective Response Rate (ORR)
The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
Time frame: 3 years
The Number of Participants Who Experienced Adverse Events (AE)
Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events).
Time frame: 3 years
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