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| Sponsored by: |
National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00019812 |
Purpose
RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to make tumor cells stop dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of trastuzumab plus paclitaxel in treating patients who have metastatic breast cancer that overexpresses HER2.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: trastuzumab Drug: paclitaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Study of Trastuzumab (Herceptin) and Paclitaxel in Patients With HER2-Overexpressing Metastatic Breast Cancer |
| Estimated Enrollment: | 55 |
| Study Start Date: | August 1999 |
OBJECTIVES:
OUTLINE: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes and paclitaxel IV over 1 hour weekly.
Patients receive trastuzumab alone during course 1 and then in combination with paclitaxel during subsequent courses. Courses repeat every 4 weeks until patients achieve a sustained complete response of 8 weeks or disease progression occurs.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Florida | |
| Holy Cross Hospital | |
| Fort Lauderdale, Florida, United States, 33308 | |
| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| United States, West Virginia | |
| Mary Babb Randolph Center | |
| Morgantown, West Virginia, United States, 26506-9162 | |
| Principal Investigator: | Susan E. Bates, MD | National Cancer Institute (NCI) |
More Information
| Study ID Numbers: | CDR0000067227, NCI-99-C-0121, NCI-T98-0087 |
| Study First Received: | July 11, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00019812 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer male breast cancer |
|
Skin Diseases Breast Neoplasms Breast Cancer, Male Antimitotic Agents Antibodies, Monoclonal Antibodies Breast Neoplasms, Male |
Paclitaxel Tubulin Modulators Trastuzumab Antineoplastic Agents, Phytogenic Breast Diseases Immunoglobulins |
|
Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Breast Neoplasms Antimitotic Agents Pharmacologic Actions Neoplasms |
Neoplasms by Site Paclitaxel Therapeutic Uses Tubulin Modulators Trastuzumab Antineoplastic Agents, Phytogenic Breast Diseases |
