S0029 Docetaxel in Treating Older Women With Metastatic 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 docetaxel in treating older women who have metastatic breast cancer.

Detailed Description
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OBJECTIVES: Determine the feasibility of treating elderly women with metastatic breast cancer with docetaxel. Determine the overall survival, 2-year survival, and response (confirmed and unconfirmed complete and partial) in patients treated with this drug. Determine the toxicity and tolerability of this drug in these patients. Determine the feasibility of using standardized self-report measures of comorbidity, depression, and functional status in elderly cancer patients. Determine the parameters of clinical pharmacology of this drug in elderly patients and in patients under 60 years of age. Determine, preliminarily, the genetic polymorphisms and gene expression levels of enzymes involved in drug metabolism and resistance in patients treated with this drug. OUTLINE: Patients are stratified according to age (70 and over vs under 60). Patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 3 years. PROJECTED ACCRUAL: Approximately 80 patients (60 patients age 70 and over and 20 patients under age 60) will be accrued for this study.

Official Title
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Single Agent Docetaxel for Metastatic Breast Cancer in Patients Aged 70 Years and Older (and in a Cohort of Patients Younger Than 60 Years)

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed breast cancer Distant metastatic disease confirmed by histology, cytology, or strong clinical evidence Measurable disease No known brain or CNS metastases Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 70 and over OR Under 60 Sex: Female Menopausal status: Not specified Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm^3 Hemoglobin at least 9 g/dL Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT or SGPT no greater than 1.5 times ULN (2.0 times ULN if liver metastases are present) Alkaline phosphatase no greater than 1.5 times ULN (2.0 times ULN if liver metastases are present) Renal: Creatinine no greater than ULN Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy for breast cancer Chemotherapy: Prior adjuvant or neoadjuvant chemotherapy allowed Prior adjuvant taxanes allowed No other concurrent chemotherapy for breast cancer Endocrine therapy: Prior hormonal therapy in the adjuvant setting or for metastatic disease allowed No concurrent hormonal therapy for breast cancer Radiotherapy: No concurrent radiotherapy for breast cancer Surgery: Not specified Other No more than 1 prior regimen for advanced, recurrent, or metastatic disease

Ages Eligible for Study
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Minimum Age: 18 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: docetaxel<br>docetaxel | Drug: docetaxel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study treatment feasibility |  | monthly for duration of accrual | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | at weeks 10 and 19, then every 3 months for 3 years | 
| Survival at 2 years |  | at weeks 10 and 19, then every 3 months for 2 years | 
| Response rate (confirmed and unconfirmed complete and partial response) |  | at weeks 10 and 19, then every 3 months for 3 years | 
| Toxicity and tolerability |  | at week 1, then every 3 weeks | 
| Feasibility of standardized self-report measures of comorbidity, depression, and functional status |  | upon completion of patient accrual | 
| Comparison of clinical pharmacologic parameters between elderly patients and patients under 60 years of age |  | upon completion of patient accrual | 

 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