Clinical trial · Interventional
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
NCT00002544CI-TRIAL-00011590completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| mitoxantrone hydrochloride | Drug | Mitoxantrone | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 80 Years
Show eligibility criteria text
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 therapyReferences
Publications (4)
- BACKGROUNDHeidemann 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.
- BACKGROUNDHeidemann 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.
- BACKGROUNDLoibl 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.
- RESULTHeidemann 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. PMID 12419743