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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00448591 |
This single arm study will assess the safety and efficacy of a regimen of Avastin plus a taxane, with or without additional chemotherapy, as first-line treatment in patients with locally recurrent or metastatic breast cancer. All patients will receive Avastin (10mg/kg iv every 2 weeks, or 15 mg/kg iv every 3 weeks) plus taxane-based chemotherapy. If taxanes are contraindicated, alternative chemotherapy (other than anthracyclines or pegylated liposomal doxorubicin) may be used. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: bevacizumab [Avastin] Drug: Taxane-based chemotherapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 2300 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | December 2011 |
Arms | Assigned Interventions |
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1: Experimental |
Drug: bevacizumab [Avastin]
10mg/kg iv on day 1 of each 3 week cycle, or 15mg/kg iv on day 1 of each 2 week cycle
Drug: Taxane-based chemotherapy
As prescribed
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Please reference Study ID Number: MO19391 | 973-235-5000 | |
Contact: or | 800-526-6367 (FOR US ONLY) |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | MO19391 |
Study First Received: | March 16, 2007 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00448591 |
Health Authority: | Australia: Joint Human Research Ethics Committee |
Skin Diseases Disease Progression Breast Neoplasms Bevacizumab |
Taxane Breast Diseases Recurrence |
Neoplasms Neoplasms by Site Antineoplastic Agents Growth Substances Therapeutic Uses |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |