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

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ClinicalTrials.gov Identifier: NCT00002544
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 2, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: docetaxel Drug: mitoxantrone hydrochloride Phase 3

Detailed Description:


  • 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 : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : May 1993
Study Completion Date : November 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 80 and under


  • Female

Menopausal status:

  • Not specified

Performance status:

  • WHO 0-2

Life expectancy:

  • At least 3 months


  • WBC greater than 4,000/mm^3
  • Absolute granulocyte count greater than 2,000/mm^3
  • Platelet count greater than 100,000/mm^3


  • 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


  • Creatinine no greater than 1.15 times ULN


  • No uncontrolled hypertension
  • No congestive heart failure within the past 6 months
  • No myocardial infarction within the past 6 months


  • Fertile patients must use effective contraception
  • No acute or chronic infection
  • No second primary tumor
  • No other serious illness


Biologic therapy:

  • No concurrent biologic therapy


  • 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


  • 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


  • Not specified


  • No concurrent anticoagulant therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002544

Diakonissen-Krankenhaus Stuttgart
Stuttgart, Germany, D-70176
Sponsors and Collaborators
Arbeitsgemeinschaft fur Internistische Onkologie
Study Chair: Else G. Heidemann, MD Diakonie Klinikum Stuttgart

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.

ClinicalTrials.gov Identifier: NCT00002544     History of Changes
Other Study ID Numbers: GER-AIO-01/92
CDR0000063279 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: April 2001

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors