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Sponsors and Collaborators: |
Dana-Farber Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00079326 |
RATIONALE: Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining trastuzumab with ixabepilone may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving trastuzumab together with ixabepilone works in treating women with HER2-positive metastatic breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Biological: trastuzumab Drug: ixabepilone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Of Trastuzumab In Combination With BMS-247550 In Women With Metastatic Breast Cancer |
Estimated Enrollment: | 60 |
Study Start Date: | February 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to prior trastuzumab (Herceptin®) therapy (with or without chemotherapy) for metastatic breast cancer (yes vs no).
Patients receive trastuzumab IV over 30-90 minutes and ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study within 12-20 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed invasive breast cancer
HER2-overexpressing tumor
At least 1 measurable lesion
Prior therapy meets 1 of the following criteria:
Cohort 1:
Cohort 2:
History of brain metastasis allowed provided the following criteria are met:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
At least 2 weeks since prior hormonal therapy in the adjuvant or metastatic setting
Radiotherapy
Other
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 | |
Cape Cod Hospital | |
Hyannis, Massachusetts, United States, 02601 | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Lowell General Hospital | |
Lowell, Massachusetts, United States, 01854 | |
Faulkner Hospital | |
Boston, Massachusetts, United States, 02130-3400 |
Study Chair: | Craig A. Bunnell, MD | Dana-Farber Cancer Institute |
Study ID Numbers: | CDR0000355176, DFCI-03202, NCI-6297 |
Study First Received: | March 8, 2004 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00079326 History of Changes |
Health Authority: | United States: Food and Drug Administration |
stage IV breast cancer recurrent breast cancer |
Skin Diseases Epothilones Tubulin Modulators Trastuzumab |
Breast Neoplasms Antimitotic Agents Breast Diseases Recurrence |
Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Epothilones Mitosis Modulators Breast Neoplasms Antimitotic Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Trastuzumab Breast Diseases |