|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Genentech |
|---|---|
| Information provided by: | Genentech |
| ClinicalTrials.gov Identifier: | NCT00434356 |
Purpose
This is a multicenter, Phase II, randomized, controlled, open label trial designed to provide a preliminary assessment of the safety and efficacy of sunitinib when combined with bevacizumab and paclitaxel in patients who have not previously received chemotherapy for locally recurrent or metastatic breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Breast Cancer |
Drug: bevacizumab Drug: sunitinib Drug: paclitaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter, Phase II, Randomized, Controlled Trial Evaluating the Efficacy and Safety of Sunitinib in Combination With Bevacizumab and Paclitaxel in Previously Untreated Patients With Metastatic Breast Cancer |
| Enrollment: | 46 |
| Study Start Date: | March 2007 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: bevacizumab
Intravenous repeating dose
Drug: sunitinib
Oral repeating dose
Drug: paclitaxel
Intravenous repeating dose
|
| Placebo Comparator: 2 |
Drug: bevacizumab
Intravenous repeating dose
Drug: paclitaxel
Intravenous repeating dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Jai Balkissoon, M.D., Study Director, Genentech, Inc. |
| ClinicalTrials.gov Identifier: | NCT00434356 History of Changes |
| Other Study ID Numbers: | AVF4057g |
| Study First Received: | February 9, 2007 |
| Results First Received: | September 1, 2009 |
| Last Updated: | November 17, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Avastin MBC Breast Cancer Sutent |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Bevacizumab Sunitinib Tubulin Modulators Antimitotic Agents Mitosis Modulators |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |