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Sponsors and Collaborators: |
Yale University Genentech |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00411788 |
Rapamune (generic name: Sirolimus®) is a drug that has been approved by the Food and Drug Administration (government) for use in patients receiving a kidney transplant to prevent the patient's body from rejecting the transplanted kidney. It has shown antitumor effects in the laboratory, but has not been approved at this time for the treatment of cancer. Herceptin is a new form of chemotherapy that has been approved by the Food and Drug Administration for the treatment of breast cancer.
This study is designed to evaluate the effect and safety of combining Rapamune and Herceptin on breast cancer. Rapamune and Herceptin are being combined because results from our laboratory studies suggest that the combination of the two drugs is superior to either drug used alone. Results from laboratory studies performed at other institutions suggest that adding Rapamune to Herceptin may also reverse the resistance to Herceptin. Although there has been extensive experience using Herceptin alone and Rapamune alone in human subjects, the combination of Herceptin and Rapamune has not been previously evaluated. In addition, we hope to better understand how these treatments work against an individual woman's tumor by analyzing tissue samples before, and during treatment.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Rapamycin Drug: Trastuzumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Study of Rapamycin (Rapamune, Sirolimus) and Trastuzumab (Herceptin) for Patients With HER-2 Receptor Positive Metastatic Breast Cancer |
Estimated Enrollment: | 30 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate bone marrow function as indicated by the following:
Exclusion Criteria:
Contact: Jeannie Kluytenaar, RN | 203-785-6523 | jeannie.kluytenaar@yale.edu |
Contact: Michele Alguard | 203-737-5908 | michele.alguard@yale.edu |
United States, Connecticut | |
Yale Comprehensive Cancer Center at Yale University School of Medicine | Recruiting |
New Haven, Connecticut, United States, 06519 | |
Bridgeport Hospital | Recruiting |
Bridgeport, Connecticut, United States, 06610 | |
Contact: Diane Eannotti, RN 203-384-4547 ndeann@bphosp.org |
Principal Investigator: | Maysa Abu-Khalaf, MD | Yale University |
Responsible Party: | Yale University School of Medicine ( Maysa Abu-Khalaf, M.D. Principal Investigator ) |
Study ID Numbers: | 0605001396 |
Study First Received: | December 14, 2006 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00411788 |
Health Authority: | United States: Institutional Review Board |
HER-2 positive breast cancer HER-2 positive breast cancer |
Sirolimus Skin Diseases Clotrimazole Miconazole |
Tioconazole Trastuzumab Breast Neoplasms Breast Diseases |
Anti-Bacterial Agents Anti-Infective Agents Neoplasms Neoplasms by Site Immunologic Factors Antineoplastic Agents |
Antifungal Agents Therapeutic Uses Physiological Effects of Drugs Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |