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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.


Phase 3
18 Years
N/A
Open (Enrolling)
Female
First Line Metastatic Breast Cancer

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Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary free survival

Outcome Time Frame:

24 months for recruitment and 18 months for follow up

Safety Issue:

No

Principal Investigator

Thomas BACHELOT, Md

Investigator Role:

Principal Investigator

Investigator Affiliation:

GINECO

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

Arobase (GINECO-BR107)

NCT ID:

NCT01303679

Start Date:

June 2010

Completion Date:

May 2018

Related Keywords:

  • First Line Metastatic Breast Cancer
  • First line metastatic breast cancer
  • Positive estrogen receptors
  • Negative HER2 receptors
  • At least stable disease after 4 months of paclitaxel-bevcizumab induction chemotheray
  • Breast Neoplasms

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