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Two Dose Levels of Capecitabine With Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Previous Anthracycline-Based Chemotherapy
This study is currently recruiting patients.
| Sponsored by: | PharmaNet |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
Purpose
RATIONALE: Drugs used in chemotherapy, such as capecitabine and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which dose of capecitabine is more effective when combined with docetaxel in treating breast cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of combining docetaxel with two dose levels of capecitabine in treating women who have locally advanced or metastatic breast cancer that has not responded to previous anthracycline-based chemotherapy (such as daunorubicin, doxorubicin, or epirubicin).
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| recurrent breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer |
Drug: capecitabine Drug: docetaxel Procedure: chemotherapy |
Phase II |
MedlinePlus related topics: Breast Cancer
Genetics Home Reference related topics: breast cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Randomized Study of Two Dose Levels of Capecitabine With Docetaxel in Women With Locally Advanced or Metastatic Breast Cancer Who Have Failed Prior Anthracycline-Based Chemotherapy
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 440 patients (220 per treatment arm) will be accrued for this study.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Location
and Contact
Information
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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