Breast Cancer
Conditions
Keywords
stage IV breast cancer, recurrent breast cancer
Brief summary
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
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.
Interventions
DRUGdocetaxel
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study treatment feasibility | monthly for duration of accrual |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Overall survival | at weeks 10 and 19, then every 3 months for 3 years |
| 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 |
| Toxicity and tolerability | at week 1, then every 3 weeks |
Outcome results
None listed