Dose Dense Doxorubucin and Cyclophosphamide Followed by Eribulin Mesylate for the Adjuvant Treatment of Early Stage Breast Cancer
The purpose of this study is to assess the feasibility of dose-dense doxorubicin and cyclophosphamide followed by eribulin mesylate for adjuvant treatment of early stage breast cancer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II, Single-Arm, Feasibility Study of Dose Dense Doxorubicin and Cyclophosphamide (AC) Followed by Eribulin Mesylate for the Adjuvant Treatment of Early Stage Breast Cancer|
- To measure the feasibility of the regimen for each individual subject. The regimen is considered feasible if the subject is able to complete the eribulin portion of the regimen without dose delay or reduction [ Time Frame: Treatment will be administered over approximately 20 weeks, i.e., dose-dense AC for 4 cycles during the first 8 weeks and eribulin mesylate for 4 cycles during the next 12 weeks. ] [ Designated as safety issue: No ]Subjects will be followed for approximately 3 years after the last dose of the study treatment.Feasibility rates will be calculated with or without growth factor support.
- To evaluate the toxicities of 4 cycles of AC followed by 4 cycles of eribulin mesylate as measured by the monitoring and recording of all adverse events, clinical laboratory results, vital signs, physical examinations, ECGs, and LVEF. [ Time Frame: Treatment will be administered over approximately 20 weeks, i.e., dose-dense AC for 4 cycles during the first 8 weeks and eribulin mesylate for 4 cycles during the next 12 weeks. ] [ Designated as safety issue: No ]Subjects will be followed for approximately 3 years after the last dose of the study treatment.
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||November 2017|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
|Experimental: Doxorubicin and cyclophosphamide followed by eribulin mesylate||
Drug: eribulin mesylate
Dose dense doxorubicin and cyclophosphamide for 4 cycles during the first 8 weeks followed by eribulin mesylate 1.4mg/m2 for 4 cycles during the next 12 weeks
This is a single-center, single-arm Phase II trial to assess the feasibility of dose-dense adjuvant chemotherapy in subjects with early stage (I-III), HER-2 normal breast cancer. A total of 80 adult subjects will be enrolled in order to have 73 subjects who start the eribulin portion of the adjuvant study regimen. After completion of 4 cycles of AC, each subject will begin 4 cycles of eribulin mesylate 1.4 mg/m2 intravenously over 2 to 5 minutes on Days 1 and 8 of every 21 day cycle.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01328249
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Study Director:||Erhan Berrak, MD||Eisai Inc.|