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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
Sponsor:
Information provided by (Responsible Party):
ARCAGY/ GINECO GROUP

Tracking Information
First Submitted Date  ICMJE September 10, 2013
First Posted Date  ICMJE September 13, 2013
Last Update Posted Date March 17, 2016
Study Start Date  ICMJE November 2013
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2013)
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%.
Original Primary Outcome Measures  ICMJE
 (submitted: September 10, 2013)
non progressive desease [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2013)
Toxicity based on the CTCAE v4.03 criteria [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First Line Metastatic Breast Cancer Treatment (ESMERALDA)
Official Title  ICMJE A PHASE II TRIAL EVALUATING THE COMBINATION OF ERIBULIN (HALAVEN®) + BEVACIZUMAB (AVASTIN®) AS A FIRST LINE TREATMENT IN PATIENTS WITH METASTATIC HER2- BREAST CANCER
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Breast Cancer
Intervention  ICMJE Drug: Eribulin
Eribulin: 1,23mg/m² d1, d8, IV Bevacizumab: 15mg/kg d1, IV
Other Name: Drug: Bevacizumab
Study Arms  ICMJE 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
Intervention: Drug: Eribulin
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 Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2015)
61
Original Estimated Enrollment  ICMJE
 (submitted: September 10, 2013)
59
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age > 18 ans
  • Patient with metastatic mammary adenocarcinoma
  • Hormone receptors ER and PR positive or negative for HER 2 negative

Exclusion Criteria:

  • Prior chemotherapy for metastatic disease
  • Previous treatment with eribulin or bevacizumab
  • Presence of symptomatic brain metastases or meningeal
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01941407
Other Study ID Numbers  ICMJE GINECO-BR110
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ARCAGY/ GINECO GROUP
Study Sponsor  ICMJE ARCAGY/ GINECO GROUP
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anne-Claire HARDY-BESSARD, MD Clinique Armoricaine de Radiologie
PRS Account ARCAGY/ GINECO GROUP
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP