Vinorelbine in Treating Older Women With Stage IV Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating older women who have stage IV breast cancer.

Detailed Description
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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.

Official Title
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Phase II Trial of Oral Vinorelbine for the Treatment of Metastatic Breast Cancer in Patients >65 Years of Age: A Trial of Efficacy, Toxicity, and Patients' Perceived Preference for Oral Therapy

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: vinorelbine tartrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vinorelbine<br>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. | Drug: vinorelbine tartrate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate |  | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to progression |  | Up to 5 years | 
| quality of life |  | Up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer, recurrent breast cancer