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

• Status: Completed
• Trial end date: 2002-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arbeitsgemeinschaft fur Internistische Onkologie
• Treatments: Docetaxel; Mitoxantrone

Criteria

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