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| Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) North Central Cancer Treatment Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00077376 |
Purpose
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 and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining trastuzumab with ixabepilone and carboplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving trastuzumab together with ixabepilone and carboplatin works in treating patients with HER2/neu-positive metastatic breast cancer.
| Condition | Intervention | Phase |
|
Breast Cancer |
Drug: carboplatin Drug: ixabepilone Drug: trastuzumab |
Phase II |
| Genetics Home Reference related topics: | breast cancer |
| MedlinePlus related topics: | Breast Cancer Cancer |
| Drug Information available for: | Carboplatin Ixabepilone Trastuzumab |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Trial Of Trastuzumab Plus Weekly Ixabepilone (BMS-247550) And Carboplatin In Patients With HER/Neu-Positive Metastatic Breast Cancer |
| Study Start Date: | March 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
NOTE: *Trastuzumab is given over 90 minutes on day 1 of course 1 (induction therapy) only.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years from study entry.
PROJECTED ACCRUAL: A total of 10-60 patients will be accrued for this study within 1-6 months.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the breast
At least 1 objectively measurable disease parameter
No untreated brain metastases
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations![]() |
Show 203 Study Locations |
| Eastern Cooperative Oncology Group |
| National Cancer Institute (NCI) |
| North Central Cancer Treatment Group |
| Study Chair: | Stacy L. Moulder, MD | H. Lee Moffitt Cancer Center and Research Institute |
| Investigator: | Joseph A. Sparano, MD | Albert Einstein College of Medicine of Yeshiva University |
| Study Chair: | Edith A. Perez, MD | Mayo Clinic |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Moulder SL, Wang M, Gradishar W, et al.: A phase II trial of trastuzumab, weekly ixabepilone and carboplatin (TIC) in patients with HER2/neu-positive (HER2+) metastatic breast cancer (MBC): a trial coordinated by the Eastern Cooperative Oncology Group (E2103). [Abstract] American Society of Clinical Oncology 2007 Breast Cancer Symposium, 7-8 September 2007, San Francisco, California A-152, 2007.
  |
| Study ID Numbers: | CDR0000350220, ECOG-E2103, NCCTG-E2103 |
| First Received: | February 10, 2004 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00077376 |
| Health Authority: | United States: Federal Government |
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