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| Sponsor: | Dana-Farber Cancer Institute |
|---|---|
| Collaborators: |
Brigham and Women's Hospital Massachusetts General Hospital Beth Israel Deaconess Medical Center Genentech |
| Information provided by: | Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01004172 |
Purpose
The purpose of this research study is to determine how well the combination of bevacizumab and carboplatin works in treating breast cancer that has spread to the brain. Bevacizumab is an antibody (a protein that attacks a foreign substance in the body) that is made in the laboratory. Bevacizumab works differently from the way chemotherapy drugs work. Usually chemotherapy drugs attack fast growing cancer cells in the body. Bevacizumab works to slow or stop the growth of cells in cancer tumors by decreasing the blood supply to the tumors. When the blood supply is decreased, the tumors don't get the oxygen and nutrients they need to grow. Carboplatin is in a class of drugs known as platinum-containing compounds and has been approved for use in the treatment of ovarian cancer. Information from other research studies suggests that the combination of bevacizumab with carboplatin may be effective in treating breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma Breast Stage IV Breast Cancer Progressive Breast Cancer |
Drug: carboplatin Drug: bevacizumab Drug: herceptin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Carboplatin and Bevacizumab for Progressive Breast Cancer Brain Metastases |
| Estimated Enrollment: | 40 |
| Study Start Date: | October 2009 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
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| Contact: Nancy Lin, MD | 617-632-2335 |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Principal Investigator: Nancy Lin, MD | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: Jerry Younger, MD | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: Gerburg Wolf, MD | |
| Principal Investigator: | Nancy Lin, MD | Dana-Farber Cancer Institute |
More Information
| Responsible Party: | Nancy Lin, MD, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01004172 History of Changes |
| Other Study ID Numbers: | 09-224 |
| Study First Received: | October 28, 2009 |
| Last Updated: | February 26, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
carboplatin bevacizumab |
|
Breast Neoplasms Carcinoma Neoplasm Metastasis Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplastic Processes Pathologic Processes |
Trastuzumab Bevacizumab Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |