- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002544
Mitoxantrone With or Without Docetaxel in Treating Women With Metastatic Breast Cancer
MITOXANTRONE (N) VS. 5-FLUOROURACIL, EPIRUBICIN AND CYCLOPHOSPHAMIDE AS FIRST-LINE CHEMOTHERAPY FOR PATIENTS WITH METASTATIC BREAST CANCER AND AN UNFAVORABLE PROGNOSIS
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Compare the survival and quality of life scores (composed of time to progression, WHO performance status, subjective patient evaluation, and subjective adverse event profile) among women with metastatic breast cancer of unfavorable prognosis treated with mitoxantrone vs mitoxantrone plus docetaxel as first-line chemotherapy for metastatic disease.
- Compare the remission rate, time to remission, remission duration, time to best response, objective adverse events, and patient acceptance of treatment on these 2 regimens.
- Investigate which prognostic subgroups of women benefit from treatment.
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.
- Arm I: Patients receive mitoxantrone IV on day 1. Treatment repeats every 3 weeks until disease progression, unacceptable toxicity, or maximum cumulative dose. Patients who achieve complete response receive 2 additional courses.
- Arm II: Patients receive mitoxantrone IV plus docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Stuttgart, Germany, D-70176
- Diakonissen-Krankenhaus Stuttgart
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically proven metastatic breast cancer of poor prognosis, defined by any of the following characteristics:
- Patient aged 35 or under
- Liver metastases
- Lung metastases combined with other disease manifestations
- Lung metastases without other disease manifestations but with a disease free interval of no more than 18 months
Indication for chemotherapy documented by either:
- Hormone receptor negativity OR
- Hormone resistant disease
Measurable metastatic disease required
Nonmeasurable disease includes:
- Metastases verified only histologically
- Tumor parameters not precisely measurable (e.g., bone marrow involvement, lymphangitic disease)
- No CNS metastasis or bone marrow carcinomatosis
Hormone receptor status:
- Receptor status known
PATIENT CHARACTERISTICS:
Age:
- 80 and under
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- WHO 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- WBC greater than 4,000/mm^3
- Absolute granulocyte count greater than 2,000/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.25 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 6 times ULN
- SGOT and/or SGPT no greater than 3 times ULN
Renal:
- Creatinine no greater than 1.15 times ULN
Cardiovascular:
- No uncontrolled hypertension
- No congestive heart failure within the past 6 months
- No myocardial infarction within the past 6 months
Other:
- Fertile patients must use effective contraception
- No acute or chronic infection
- No second primary tumor
- No other serious illness
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent biologic therapy
Chemotherapy:
- No prior chemotherapy for metastatic disease
- Greater than 1 year since prior adjuvant chemotherapy
- No prior anthracycline or anthraquinone
Endocrine therapy:
- Hormone resistant disease required of receptor positive patients
- No concurrent endocrine therapy
Radiotherapy:
- No prior mediastinal irradiation
- Adjuvant irradiation of parasternal nodes eligible
- No prior irradiation to more than 25% of bone marrow
- No concurrent irradiation of sole measurable lesion
Surgery:
- Not specified
Other:
- No concurrent anticoagulant therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
Collaborators and Investigators
Investigators
- Study Chair: Else G. Heidemann, MD, Diakonie-Klinikum Stuttgart
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- Heidemann E, Stoeger H, Souchon R, Hirschmann WD, Bodenstein H, Oberhoff C, Fischer JT, Schulze M, Clemens M, Andreesen R, Mahlke M, Konig M, Scharl A, Fehnle K, Kaufmann M. Is first-line single-agent mitoxantrone in the treatment of high-risk metastatic breast cancer patients as effective as combination chemotherapy? No difference in survival but higher quality of life were found in a multicenter randomized trial. Ann Oncol. 2002 Nov;13(11):1717-29. doi: 10.1093/annonc/mdf306.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Docetaxel
- Mitoxantrone
Other Study ID Numbers
- GER-AIO-01/92
- CDR0000063279 (Registry Identifier: PDQ (Physician Data Query))
- EU-93011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of California, IrvineNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedBreast Cancer | HER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer | HER2-negative Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-positive Breast CancerUnited States
Clinical Trials on docetaxel
-
Nereus Pharmaceuticals, Inc.CompletedCancerUnited States, Australia, India, Chile, Brazil, Argentina
-
Tianjin Medical University Cancer Institute and...Recruiting
-
Zhuhai Beihai Biotech Co., LtdCompletedSolid Tumours | Bioequivalence | DocetaxelIndia
-
Jiangsu HengRui Medicine Co., Ltd.Shanghai Pulmonary Hospital, Shanghai, ChinaCompletedNon-Small Cell Lung Cancer (NSCLC)China
-
National Cancer Center, KoreaSeoul National University Bundang Hospital; Gachon University Gil Medical Center and other collaboratorsUnknownGastric CancerKorea, Republic of
-
Optimal Health ResearchCompletedBreast Cancer | Lung Cancer | Prostate CancerUnited States
-
Arog Pharmaceuticals, Inc.WithdrawnCarcinoma, Non-Small-Cell Lung
-
Boehringer IngelheimCompletedCarcinoma, Non-Small-Cell LungJapan
-
SanofiCompleted
-
SanofiCompletedLung NeoplasmsFrance, Netherlands, Spain, Turkey, Belgium, Finland, Italy, United Kingdom