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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002544
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 2, 2013
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date August 2, 2013
Study Start Date  ICMJE May 1993
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00002544 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Mitoxantrone With or Without Docetaxel in Treating Women With Metastatic Breast Cancer
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


  • 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: docetaxel
  • Drug: mitoxantrone hydrochloride
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February¬†20,¬†2007)
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2002
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE


  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE up to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00002544
Other Study ID Numbers  ICMJE GER-AIO-01/92
CDR0000063279 ( Registry Identifier: PDQ (Physician Data Query) )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Arbeitsgemeinschaft fur Internistische Onkologie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Else G. Heidemann, MD Diakonie Klinikum Stuttgart
PRS Account National Cancer Institute (NCI)
Verification Date April 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP