Mitoxantrone With or Without Docetaxel in Treating Women With Metastatic Breast Cancer

NCT00002544 | Completed Phase 3

• 3 other identifiers: GER-AIO-01/92CDR0000063279EU-93011
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Interventions

docetaxel DRUG

mitoxantrone hydrochloride DRUG

Eligibility Criteria

• Age: Up to 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Arbeitsgemeinschaft fur Internistische Onkologie: lead

Study Sites (1)

Diakonissen-Krankenhaus Stuttgart

Stuttgart, D-70176, Germany

Location

Related Publications (4)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 12419743 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Mitoxantrone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Quinones; Polycyclic Compounds

Study Officials

• Else G. Heidemann, MD

  Diakonie-Klinikum Stuttgart

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: May 1, 1993
• Study Completion: November 1, 2002
• Last Updated: August 2, 2013

Record last verified: 2001-04

Locations

DE (1)