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Sponsored by: |
Arbeitsgemeinschaft fur Internistische Onkologie |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002544 |
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 if mitoxantrone is more effective with or without docetaxel.
PURPOSE: Randomized phase III trial to compare the effectiveness of mitoxantrone with or without docetaxel in treating women who have metastatic breast cancer with a poor prognosis.
Condition | Intervention | Phase |
Breast Cancer |
Drug: docetaxel Drug: mitoxantrone hydrochloride |
Phase III |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer |
ChemIDplus related topics: | Cyclophosphamide Docetaxel Mitoxantrone hydrochloride Mitoxantrone Fluorouracil Epirubicin hydrochloride Epirubicin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | MITOXANTRONE (N) VS. 5-FLUOROURACIL, EPIRUBICIN AND CYCLOPHOSPHAMIDE AS FIRST-LINE CHEMOTHERAPY FOR PATIENTS WITH METASTATIC BREAST CANCER AND AN UNFAVORABLE PROGNOSIS |
Estimated Enrollment: | 300 |
Study Start Date: | May 1993 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age, treatment center, disease free interval (no more than 18 months vs more than 18 months), hormone receptor status (positive or unknown vs negative), prior adjuvant therapy with anthracyclines (yes vs no), presence of liver metastases (liver involvement as a single organ vs liver plus other organ involvement vs no liver involvement), and presence of lung metastases (yes vs no). Patients are randomized to 1 of 2 treatment arms.
At relapse, reinduction with the original regimen is attempted. Following a second complete response, 2 additional courses of consolidative treatment are given, and patients are then followed off treatment.
Quality of life is assessed periodically.
PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.
Ages Eligible for Study: | up to 80 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven metastatic breast cancer of poor prognosis, defined by any of the following characteristics:
Indication for chemotherapy documented by either:
Measurable metastatic disease required
Nonmeasurable disease includes:
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:
Other:
Germany | |||||
Diakonissen-Krankenhaus Stuttgart | |||||
Stuttgart, Germany, D-70176 |
Arbeitsgemeinschaft fur Internistische Onkologie |
Study Chair: | Else G. Heidemann, MD | Diakonie Klinikum Stuttgart |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Heidemann E, Souchon R, Stoger H, et al.: First-line monochemotherapy with mitoxantrone versus combination with fluorouracil, epirubicin and cyclophosphamide in high-risk metastatic breast cancer: a prospective randomized multicenter clinical trial. Onkologie 23(1): 54-59, 2000.
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Heidemann E, Stoeger H, Souchon R, et al.: Balance of time to progression, quality of life, and overall survival: more gain from treatment in single agent treatment with mitoxantrone (N) than with the combination of fluorouracil, epirubicin, cyclophosphamide (FEC). Results of a multicenter randomized trial in high risk metastatic breast cancer (MBC). [Abstract] Proceedings of the American Society of Clinical Oncology A-284, 74a, 2000.
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Loibl S, von Minckwitz G, Souchon R, et al.: Phase I/II study with mitoxantrone (N) vs. NDOC in patients with high risk locally advanced or metastatic breast cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A512, 1999.
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Study ID Numbers: | CDR0000063279, GER-AIO-01/92, EU-93011 |
First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002544 |
Health Authority: | United States: Federal Government |
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