Dose-Dense Chemotherapy Plus Bevacizumab in High Risk Lymph Node Positive Breast Cancer: A Pilot Study
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|ClinicalTrials.gov Identifier: NCT00378638|
Recruitment Status : Unknown
Verified October 2007 by Chap, Linnea I., M.D..
Recruitment status was: Recruiting
First Posted : September 20, 2006
Last Update Posted : October 24, 2007
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: bevacizumab combined with dose dense chemotherapy||Phase 2|
Approximately 200,000 women are diagnosed with breast cancer in the United States every year. A significant factor determining long-term survivability of breast cancer is whether or not lymph nodes, glands which cleanse and filter the body's fluids, are involved. Despite treatment with approved multiagent cytotoxic chemotherapy ("dose-dense chemotherapy"), women with breast cancer involving more than 4 axillary lymph nodes still have a high risk for recurrence.
Several dose-dense chemotherapy regimens are currently being compared in other studies, however, at this time there is no proof that one regimen is superior to another. Therefore, in an attempt to decrease metastases, prolong time to recurrence and improve overall survival, it is essential to develop novel therapeutic strategies. The use of inhibitors of angiogenesis represents a promising option.
Bevacizumab is the first angiogenesis inhibiting drug to be FDA approved, for the treatment of colon cancer. It is has also been studied alone in progressed lymph-node positive breast cancer and has shown moderate efficacy.
This study will observe the efficacy and tolerability of using bevacizumab in combination with an approved dose-dense chemotherapy regimen for 8 cycles, followed by 12 of bevacizumab alone. Patients may be on the study for up to 52 weeks if their disease has not progressed and the regimen is tolerated.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dose-Dense Chemotherapy Plus Bevacizumab in High Risk Lymp Node Positive Breast Cancer: A Pilot Study|
|Study Start Date :||June 2006|
|Estimated Study Completion Date :||October 2008|
- Incidence of treatment failure, 2 and 5 year Disease Free Survival.
- 2 and 5 Year Disease Free Survival.
- Overall survival.
- Circulating Tumor Cells and Circulating Endothelial Progenitor Cells assays results and their association with clinical outcomes.
- Toxicities and adverse events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00378638
|Contact: Linnea I. Chap, MD||(310) email@example.com|
|Contact: Marilyn Mulay, MSN||(310) firstname.lastname@example.org|
|United States, California|
|Santa Monica, California, United States, 90404|
|Contact: Linnea I. Chap, M.D. 310-633-8400 email@example.com|
|Contact: Marilyn Mulay, MSN (310) 633-8400 firstname.lastname@example.org|
|Principal Investigator: Linnea I. Chap, M.D.|
|Principal Investigator:||Linnea I. Chap, MD||Premiere Oncology, A Medical Corporation|