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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

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.


Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Eribulin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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
Drug: Eribulin
Eribulin: 1,23mg/m² d1, d8, IV Bevacizumab: 15mg/kg d1, IV
Other Name: Drug: Bevacizumab




Primary Outcome Measures :
  1. 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%.



Secondary Outcome Measures :
  1. Toxicity based on the CTCAE v4.03 criteria [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
ARCAGY/ GINECO GROUP
Investigators
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Principal Investigator: Anne-Claire HARDY-BESSARD, MD Clinique Armoricaine de Radiologie
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Responsible Party: ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier: NCT01941407    
Other Study ID Numbers: GINECO-BR110
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors