RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Some patients may develop a resistance to chemotherapy drugs. PURPOSE: Phase II trial to determine the reliability of a test for measuring drug resistance to paclitaxel in patients with metastatic breast cancer.

Condition	Treatment or Intervention	Phase
Male Breast Cancer stage IV breast cancer recurrent breast cancer	Procedure: diagnostic  Procedure: chemotherapy  Drug: paclitaxel	Phase II

Further Study Details: 

OBJECTIVES: I. Evaluate the proportion of patients with extreme, intermediate, and low drug resistance to paclitaxel using the Extreme Drug Resistance (EDR) Assay in patients with previously treated metastatic breast cancer. II. Assess response to paclitaxel therapy in patients who have undergone a pretreatment EDR assay. III. Assess time to tumor progression during paclitaxel therapy in patients who have undergone a pretreatment EDR assay. IV. Determine prospectively the predictive value of the EDR assay relative to clinical outcome by correlating assay results with clinical tumor response and time to tumor progression during paclitaxel therapy in these patients.

PROTOCOL OUTLINE: This is an open label, single arm, blinded study. Patients' tumor tissue samples are collected by excisional biopsy, core biopsy, or malignant fluid aspiration, then tested by the Extreme Drug Resistance (EDR) Assay to determine probability of drug resistance to paclitaxel. After successful completion of the EDR assay (approximately 7 days), patients receive paclitaxel by intravenous infusion over 1-3 hours; treatment is repeated every 3 weeks. Treatment continues until there is documented evidence of tumor progression or unacceptable toxicity. Patients' clinical response to paclitaxel therapy is compared with the response predicted by the EDR assay.

PROJECTED ACCRUAL: 100 patients will be accrued to this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Metastatic breast cancer that is accessible for biopsy or aspiration
• Bidimensionally measurable disease with at least one diameter greater than 1 cm documented on x-ray or photograph, or a palpable lesion
• No brain metastases or carcinomatous meningitis
• Hormone receptor status: Not specified

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: See Disease Characteristics; Prior paclitaxel permitted if patient had disease-free interval of greater than 1 year; Prior taxotere permitted
• Endocrine therapy: Not specified
• Radiotherapy: Not specified
• Surgery: Not specified

--Patient Characteristics--

• Age: 18 and over
• Sex: Male or female
• Menopausal status: Not specified
• Performance status: SWOG 0-2
• Life expectancy: Not specified
• Hematopoietic: Absolute neutrophil count greater than 1,500/mm3; Platelet count greater than 100,000/mm3
• Hepatic: Bilirubin no greater than 2.0 mg/dL; SGOT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if metastatic to liver)
• Renal: Creatinine no greater than 2.0 mg/dL; Calcium no greater than 12 mg/dL
• Cardiovascular: No myocardial infarction within 3 months prior to study; No unstable angina or symptomatic congestive heart failure
• Other: No active or uncontrolled infection; Not HIV positive; No psychoses; Not pregnant or nursing; Effective contraception required of fertile women; No second malignancy within past 5 years except: Adequately treated basal or squamous cell carcinoma of the skin; In situ cancer of the cervix

California
      Chao Family Comprehensive Cancer Center, Orange,  California,  92868,  United States
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States
      Long Beach Memorial Breast Center, Long Beach,  California,  90806,  United States
      Pacific Coast Hematology/Oncology Medical Group, Fountain Valley,  California,  92708,  United States
      USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles,  California,  90033-0804,  United States
District of Columbia
      Howard University, Washington,  District of Columbia,  20059,  United States
Louisiana
      Louisiana State University Health Sciences Center - Shreveport, Shreveport,  Louisiana,  71130-3932,  United States
South Carolina
      Palmetto Hematology/Oncology Associates, Spartanburg,  South Carolina,  29303,  United States
Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States

Study chairs or principal investigators

Rita S. Mehta,  Study Chair,  Oncotech   

Study ID Numbers:  CDR0000066135; ONCOTECH-OTBR01; NCI-V98-1391; UCIRVINE-97-02
Record last reviewed:  November 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003253
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08