Vinorelbine in Treating Older Women With Stage IV Breast Cancer

OBJECTIVES:

- Determine the objective response rate in elderly women with stage IV breast cancer
treated with oral vinorelbine.

- Determine the toxicity profile of this drug in these patients.

- Determine the time to progression in patients treated with this drug.

- Determine the quality of life of patients treated with this drug.

- Assess individual variation in responses (toxicity and/or activity), pharmacokinetic
parameters, and/or biologic correlates due to genetic differences in enzymes involved
in the transport, metabolism, and/or mechanism of action of this drug in these
patients.

OUTLINE: Patients receive oral vinorelbine once weekly. Courses repeat every 4 weeks in the
absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then after completion of the second course.

Patients are followed every 3 months for 5 years.

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed stage IV breast cancer

- Eligible to receive first- or second-line chemotherapy

- At least 1 unidimensionally measurable lesion

- At least 20 mm in longest diameter

- Must be completely outside prior irradiation port unless there is proof of
progressive disease after completion of prior radiotherapy

- No untreated brain metastases

- Current metastatic CNS disease allowed only if previously treated and clinically
stable at study entry

- No meningeal carcinomatosis

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age:

- 65 and over

Sex:

- Female

Menopausal status:

- Not specified

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Total bilirubin no greater than 1.5 times upper limit of normal (ULN) OR

- Direct bilirubin normal if total bilirubin elevated or less than 2.5 times ULN
because of Gilbert's syndrome

Renal:

- Creatinine no greater than 2 times ULN

Other:

- No grade 2 or greater peripheral neuropathy

- No other significant medical condition that would preclude study

- No active infection within the past 2 weeks

- No dysphagia or inability to swallow intact capsules

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

- No more than 1 prior chemotherapy regimen for metastatic disease

- No prior vinca alkaloids

- At least 4 weeks since other prior chemotherapy and recovered

Endocrine therapy:

- Prior hormonal therapy allowed

- No concurrent hormonal therapy

Radiotherapy:

- See Disease Characteristics

- No prior radiotherapy to 25% or more of bone marrow

- At least 3 weeks since prior radiotherapy and recovered

Surgery:

- At least 3 weeks since prior major surgery