First Line Metastatic Breast Cancer Treatment (ESMERALDA) (ESMERALDA)
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|ClinicalTrials.gov Identifier: NCT01941407|
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : March 17, 2016
The efficacy of eribulin is now well known in metastatic breast cancer. Furthermore, a phase III combine study ( chemo + bev)in metastatic first line shown a gain in PFS with no extra toxicities.
It could be interesting to explore the combination of bev + eribulin in first line metastatic breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: Eribulin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A PHASE II TRIAL EVALUATING THE COMBINATION OF ERIBULIN (HALAVEN®) + BEVACIZUMAB (AVASTIN®) AS A FIRST LINE TREATMENT IN PATIENTS WITH METASTATIC HER2- BREAST CANCER|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||March 2016|
Experimental: Association eribulin and bevacizumab
Drug: eribulin 1,23mg/m²; d1 and d8 in IV, all 3 weeks until 6 cycles or progression Drug: bevacizumab 15m/kg ; d1 in IV, all 3 weeks until 6 cycles or progression or toxicity
Eribulin: 1,23mg/m² d1, d8, IV Bevacizumab: 15mg/kg d1, IV
Other Name: Drug: Bevacizumab
- Number of patient with non progressive disease [ Time Frame: 12 months ]
The principal endpoint is to determine the disease control rate (or rate of non-progression) at one year in patients with metastatic breast cancer treated in the first line setting by a combination of eribulin/bevacizumab.
In this open-label trial, the sample size is calculated based on Simon's two-stage design, used to test whether the disease control rate at one year will be at least 50%, a clinically promising rate, versus a rate of 33%, a rate that is not clinically promising.
Considering a type I risk (alpha) error of 5%, with 54 patients, this study has an 80% power to detect a disease control rate at one year of 50%.
- Toxicity based on the CTCAE v4.03 criteria [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941407
|Principal Investigator:||Anne-Claire HARDY-BESSARD, MD||Clinique Armoricaine de Radiologie|