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Sponsored by: |
Federation Nationale des Centres de Lutte Contre le Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00104624 |
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well docetaxel works in treating older women with metastatic breast cancer and whether it helps improve the ability to perform daily activities.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer Cancer-Related Problem/Condition |
Drug: docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial Assessing the Impact on Instrumental and Daily Living Autonomy of a Chemotherapy With Biweekly Docetaxel in the Treatment of Metastatic Breast Cancer in Patients Over 70 |
Estimated Enrollment: | 53 |
Study Start Date: | December 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV on days 1 and 15. Treatment repeats every 28 days for 6 courses.
Ability to perform daily activities is assessed periodically.
PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.
Ages Eligible for Study: | 70 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the breast
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Meets both of the following criteria:
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent chronic corticosteroids
Radiotherapy
Surgery
Other
France | |
C.H. Senlis | |
Senlis, France, 60309 | |
Centre Henri Becquerel | |
Rouen, France, 76038 | |
Institut Curie Hopital | |
Paris, France, 75248 | |
Institut Gustave Roussy | |
Villejuif, France, F-94805 | |
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes | |
Marseille, France, 13273 | |
Italy | |
Istituto Nazionale Di Riposo e Cura per Anziani | |
Rome, Italy, 00189 | |
Switzerland | |
Clinique De Genolier | |
Genolier, Switzerland, Ch-1272 |
Study Chair: | Suzette Delaloge | Institut Gustave Roussy |
Study ID Numbers: | CDR0000417747, FRE-FNCLCC-GERICO-04/0406, EU-20504 |
Study First Received: | March 3, 2005 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00104624 History of Changes |
Health Authority: | United States: Federal Government |
quality of life stage IV breast cancer recurrent breast cancer |
Docetaxel Skin Diseases Quality of Life |
Breast Neoplasms Breast Diseases Recurrence |
Docetaxel Neoplasms Neoplasms by Site Skin Diseases Antineoplastic Agents |
Therapeutic Uses Breast Neoplasms Pharmacologic Actions Breast Diseases |