Text Size

1st Line Treatment of Bevacizumab-Taxane vs Bevacizumab-Exemestane in Metastatic Breast Cancer

This study is currently recruiting participants.
Verified June 2012 by ARCAGY/ GINECO GROUP
Sponsor:
Information provided by (Responsible Party):
ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier:
NCT01303679
First received: February 23, 2011
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  Purpose

In first-line metastatic breast cancer, the bevacizumab-taxane to progression or toxicity, is currently the standard treatment. In patients expressing hormone receptors, it was shown that hormone therapy administered in maintenance after induction chemotherapy, could have a benefit regarding the progression-free survival. The investigators make the hypothesis that there would be interest to discontinue treatment with taxane after 4 months, and to begin hormone therapy while continuing maintenance bevacizumab.

Exemestane was chosen because it has been shown potentially active in patients who progressed after letrozole, anastrozole or tamoxifen.


Condition Intervention Phase
First Line Metastatic Breast Cancer
 Drug: Paclitaxel
Drug: Bevacizumab
Drug: Exemestane
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Randomized Multicenter Trial Comparing Continued Maintenance Therapy With the Bevacizumab + Taxane Versus Bevacizumab + Substituting Exemestane in Patients With Metastatic Breast Cancer or Locally Advanced With Estrogen Receptor Positive and Having at Least a Stable Disease After 16 to 18 Weeks of Treatment With Bevacizumab + Taxane.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ARCAGY/ GINECO GROUP:

Primary Outcome Measures:
  • Primary free survival [ Time Frame: 24 months for recruitment and 18 months for follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 198
Study Start Date: June 2010
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: paclitaxel-bevacizumab
Paclitaxel, 80mg/m² at d1, d8, d15 bevacizumab, 10 mg/kg at d1, d15
 Drug: Paclitaxel
IV, 80mg/m² at d1, d8, d15
Drug: Bevacizumab
IV, 10 mg/kg at d1, d15 or IV, 15 mg/kg every 3 weeks
Experimental: exemestane-bevacizumab
exemestane, 25 mg daily dose bevacizumab, 15mg/kg every 3 weeks
 Drug: Bevacizumab
IV, 10 mg/kg at d1, d15 or IV, 15 mg/kg every 3 weeks
Drug: Exemestane
daily 25 mg (1 pill) oral intake

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 ans.
  • Metastatic breast cancer or locally advanced
  • RE+, HER2-
  • Patient receiving paclitaxel-bevacizumab first line chemotherapy

Exclusion Criteria:

  • Previous treatment by exemestane (both in adjuvant or metastatic treatment).
  • 1st line of chemotherapy different thaan paclitaxel-bevacizumab.
  • Treatment by paclitaxel-bevacizumab > 18 weeks.
  • HER2 positifs et/ou récepteurs aux oestrogènes négatifs.
  • Previous thrombosis event within the 6 months before inclusion .
  • Previous significant surgery within the 28 days before treatment start
  • Previuous coagulopathy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01303679

Contacts
Contact: Douglas MICHEAU +33 1 42 34 83 23 dmicheau@arcagy.org

Locations
France
BACHELOT Recruiting
Lyon, France, 69000
Contact: Thomas BACHELOT, Md     + 33 4 78 78 26 54     bachelot@lyon.fnclcc.fr    
Sponsors and Collaborators
ARCAGY/ GINECO GROUP
Investigators
Principal Investigator: Thomas BACHELOT, Md GINECO
  More Information

No publications provided

Responsible Party: ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier: NCT01303679     History of Changes
Other Study ID Numbers: Arobase (GINECO-BR107)
Study First Received: February 23, 2011
Last Updated: June 12, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France : CPP

Keywords provided by ARCAGY/ GINECO GROUP:
First line metastatic breast cancer
Positive estrogen receptors
Negative HER2 receptors
At least stable disease after 4 months of paclitaxel-bevcizumab induction chemotheray

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Estrogens
Exemestane
Bevacizumab
Paclitaxel
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
 Antineoplastic Agents
Therapeutic Uses
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013