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| Sponsor: | Aventis Pharmaceuticals |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002662 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether paclitaxel is more effective than docetaxel for breast cancer.
PURPOSE: Randomized phase III trial to study the effectiveness of paclitaxel or docetaxel in treating women with stage IIIB or metastatic breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: docetaxel Drug: paclitaxel |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | PHASE III COMPARISON OF TAXOTERE (DOCETAXEL) AND TAXOL (PACLITAXEL) IN PATIENTS WITH ADVANCED BREAST CANCER |
| Study Start Date: | August 1994 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline and after courses 4 and 6.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 400 patients (200 per arm) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven metastatic or locally advanced, inoperable adenocarcinoma of the breast
Must meet 1 of the following conditions:
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:
No concurrent corticosteroids except:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 32 Study Locations| Study Chair: | Peter M. Ravdin, MD | University of Texas |
More Information
| ClinicalTrials.gov Identifier: | NCT00002662 History of Changes |
| Other Study ID Numbers: | CDR0000064232, AVENTIS-56976-TAX-311, RP-56976-TAX-311, NCI-V95-0680 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer stage IIIA breast cancer recurrent breast cancer stage IIIB breast cancer stage IIIC breast cancer |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Docetaxel Tubulin Modulators |
Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |