A Randomized Phase III Trial of Eribulin Compared to Standard Weekly Paclitaxel as First- or Second-Line Therapy for Locally Recurrent or Metastatic Breast Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02037529 |
Recruitment Status
:
Recruiting
First Posted
: January 16, 2014
Last Update Posted
: March 14, 2018
|
Sponsor:
Academic and Community Cancer Research United
Information provided by (Responsible Party):
Academic and Community Cancer Research United
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | January 14, 2014 | ||||
First Posted Date ICMJE | January 16, 2014 | ||||
Last Update Posted Date | March 14, 2018 | ||||
Study Start Date ICMJE | March 2014 | ||||
Estimated Primary Completion Date | June 2018 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Overall Survival (OS) of subjects from Baseline taking eribulin mesylate vs. subjects taking paclitaxel [ Time Frame: Baseline until death, or up to 4 years ] The time from randomization to death due to any cause; subjects who are lost to follow-up and subjects who are alive at the date of data cut-off will be censored at the date the subject was last known alive.
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT02037529 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | Not Provided | ||||
Original Other Outcome Measures ICMJE | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Randomized Phase III Trial of Eribulin Compared to Standard Weekly Paclitaxel as First- or Second-Line Therapy for Locally Recurrent or Metastatic Breast Cancer | ||||
Official Title ICMJE | Not Provided | ||||
Brief Summary | This is a two arm Phase III trial in first and second-line HER2 negative patients with locally recurrent or metastatic breast cancer. The primary endpoint is overall survival (OS), and the objective is to test for the superiority of eribulin mesylate over standard weekly paclitaxel. Patients will be randomized between the experimental and control arm with equal allocation (1:1) within strata defined by prior adjuvant taxanes, hormone receptor status, and line of therapy. Subjects will continue protocol directed therapy until documentation of disease progression, development of unacceptable toxicity, or withdrawal of consent. Those who discontinue study treatment without radiological progression will be followed with repeat imaging studies every 12 weeks. All subjects will be followed until death, withdrawal of consent, or study termination. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||
Condition ICMJE |
|
||||
Intervention ICMJE |
|
||||
Study Arms |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
910 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date | June 2019 | ||||
Estimated Primary Completion Date | June 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender |
|
||||
Ages | 18 Years and older (Adult, Senior) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
|
||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02037529 | ||||
Other Study ID Numbers ICMJE | E7389-A001-303 RU011201I ( Other Identifier: ACCRU ) |
||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement | Not Provided | ||||
Responsible Party | Academic and Community Cancer Research United | ||||
Study Sponsor ICMJE | Academic and Community Cancer Research United | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
|
||||
PRS Account | Academic and Community Cancer Research United | ||||
Verification Date | July 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |