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

NCT ID: NCT00002544

Last Updated: 2013-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1993-05-31
• Study Completion Date: 2002-11-30

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.

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

docetaxel

Intervention Type: DRUG

mitoxantrone hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Arbeitsgemeinschaft fur Internistische Onkologie

OTHER

Sponsor Role: lead

Principal Investigators

Else G. Heidemann, MD

Role: STUDY_CHAIR

Diakonie-Klinikum Stuttgart

Locations

Diakonissen-Krankenhaus Stuttgart

Stuttgart, , Germany

Countries

Germany

References

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.

Reference Type: 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.

Reference Type: 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.

Reference Type: 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.

Reference Type: RESULT

PMID: 12419743 (View on PubMed)

Other Identifiers

CDR0000063279

Identifier Type: REGISTRY

Identifier Source: secondary_id

EU-93011

Identifier Type: -

Identifier Source: secondary_id

GER-AIO-01/92

Identifier Type: -

Identifier Source: org_study_id