1st Line Treatment of Bevacizumab-Taxane vs Bevacizumab-Exemestane in 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. Read our disclaimer for details. Identifier: NCT01303679
Recruitment Status : Terminated (Not reveal any significant difference between the 2 treatment arms)
First Posted : February 25, 2011
Last Update Posted : May 18, 2018
Information provided by (Responsible Party):

Brief Summary:

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 or disease Intervention/treatment Phase
First Line Metastatic Breast Cancer Drug: Paclitaxel Drug: Bevacizumab Drug: Exemestane Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : June 2010
Actual Primary Completion Date : June 2014
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Primary free survival [ Time Frame: 24 months for recruitment and 18 months for follow up ]

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

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.

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 identifier (NCT number): NCT01303679

Lyon, France, 69000
Sponsors and Collaborators
Principal Investigator: Thomas BACHELOT, Md GINECO

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: ARCAGY/ GINECO GROUP Identifier: NCT01303679     History of Changes
Other Study ID Numbers: Arobase (GINECO-BR107)
First Posted: February 25, 2011    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: March 2016

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
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists