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

Launched by ARBEITSGEMEINSCHAFT FUR INTERNISTISCHE ONKOLOGIE · Jan 26, 2003

Keywords

ClinConnect Summary

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...

Gender

FEMALE

Eligibility 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

Trial Officials