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An Open-label Study to Evaluate the Safety and Effect on Disease Progression and Overall Survival of Avastin Plus Taxane-based Chemotherapy in Patients With Locally Recurrent or Metastatic Breast Cancer


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

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Trial Information

An Open-label Study to Evaluate the Safety and Effect on Disease Progression and Overall Survival of Avastin Plus Taxane-based Chemotherapy in Patients With Locally Recurrent or Metastatic Breast Cancer


Inclusion Criteria:



- patients, >=18 years of age;

- HER-2 negative adenocarcinoma of the breast, with locally recurrent or metastatic
disease; (HER-2 positive patients only if previously treated with Herceptin in the
adjuvant setting;

- candidates for chemotherapy.

Exclusion Criteria:

- previous chemotherapy for metastatic or locally recurrent breast cancer;

- concomitant hormonal therapy for metastatic or locally recurrent disease;

- concomitant Herceptin therapy for treatment of metastatic or locally recurrent HER-2
positive disease;

- previous radiotherapy for treatment of metastatic disease;

- evidence of CNS metastases.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of AEs, and SAEs related to Avastin

Outcome Time Frame:

Throughout study

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Australia: Joint Human Research Ethics Committee

Study ID:

MO19391

NCT ID:

NCT00448591

Start Date:

September 2006

Completion Date:

March 2011

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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