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A Randomized, Double-blind Study of the Effect of First Line Treatment With Avastin (Bevacizumab) in Combination With Docetaxel on Progression-free Survival and Disease Response in Patients With HER2 Negative Metastatic Breast Cancer


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

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Trial Information

A Randomized, Double-blind Study of the Effect of First Line Treatment With Avastin (Bevacizumab) in Combination With Docetaxel on Progression-free Survival and Disease Response in Patients With HER2 Negative Metastatic Breast Cancer


Inclusion Criteria:



- female patients >= 18 years of age;

- HER2 negative cancer of the breast with locally recurrent or metastatic disease,
suitable for chemotherapy;

- no adjuvant chemotherapy within 6 months before randomization, and no taxane-based
chemotherapy within 12 months before randomization;

- ECOG performance status 0-1.

Exclusion Criteria:

- previous chemotherapy for metastatic or locally recurrent breast cancer;

- radiotherapy for treatment of metastatic disease;

- other primary tumors within last 5 years, except for controlled limited basal cell or
squamous cancer of the skin, or cancer in situ of the cervix;

- spinal cord compression or brain metastases;

- major surgical procedure, open biopsy or significant traumatic injury within 28 days
prior to randomization;

- inadequate bone marrow, liver or renal function;

- uncontrolled hypertension.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

Event driven

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

France: AFSSAPS (Agence francaise de securite sanitaire des produits de Sante)

Study ID:

BO17708

NCT ID:

NCT00333775

Start Date:

March 2006

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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