Breast Cancer Clinical Trial

Docetaxel in Treating Patients With Metastatic Breast Cancer

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Randomized phase III trial to determine the effectiveness of docetaxel in treating patients who have metastatic breast cancer.

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Full Description

OBJECTIVES:

Compare the objective tumor response rate, duration of response, time to progression, progression-free survival, and overall survival in women with metastatic breast cancer treated with docetaxel administered weekly vs every three weeks.
Compare the safety and toxicity of these regimens in these patients.
Evaluate the maintenance of relative dose intensity with each regimen in these patients.
Correlate pretreatment serum HER2/neu level and response with docetaxel therapy in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior taxane use (yes vs no), number of prior chemotherapy regimens for metastatic disease (0 vs 1), and participating center. Patients are randomized to one of two treatment arms.

Arm I: Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days.
Arm II: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days.

Treatment continues in both arms in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3 weeks, at 3, 6, 9, and 12 months, and then annually for 4 years.

PROJECTED ACCRUAL: A total of 160 patients will be accrued for this study.

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Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed metastatic breast cancer
Bidimensionally measurable disease
No uncontrolled brain metastases or leptomeningeal disease

Hormone receptor status:

Not specified

PATIENT CHARACTERISTICS:

Age:

18 and over

Sex:

Female

Menopausal status:

Not specified

Performance status:

Zubrod 0-2

Life expectancy:

At least 3 months

Hematopoietic:

Platelet count at least 100,000/mm^3
Neutrophil count at least 1,000/mm^3
Hemoglobin at least 8 g/dL

Hepatic:

Bilirubin no greater than upper limit of normal (ULN)
SGOT/SGPT no greater than 1.5 times ULN (2.5 times ULN provided alkaline phosphatase no greater than ULN)
Alkaline phosphatase no greater than 2.5 times ULN (4 times ULN provided transaminases no greater than ULN)

Renal:

Creatinine no greater than 2.0 mg/dL

Neurologic:

No peripheral neuropathy grade 2 or greater
Neurologic status must be stable 2 weeks after surgery and/or radiotherapy for brain metastasis
No psychiatric disorders

Other:

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No other malignancy within the past 5 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or other curatively treated malignancy
No other serious condition or illness, including active infection
No history of hypersensitivity to polysorbate 80

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

Recovered from prior chemotherapy
No more than 2 prior chemotherapy regimens (no more than 1 prior regimen for metastatic disease)
No prior paclitaxel or docetaxel (except in the adjuvant setting)
At least 12 months since prior adjuvant taxane (paclitaxel or docetaxel)
Prior anthracycline-based therapy allowed

Endocrine therapy:

Not specified

Radiotherapy:

At least 2 weeks since prior radiotherapy and recovered

Surgery:

At least 2 weeks since prior surgery and recovered

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

90

Study ID:

NCT00008411

Recruitment Status:

Completed

Sponsor:

M.D. Anderson Cancer Center

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There is 1 Location for this study

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MD Anderson Cancer Center at University of Texas
Houston Texas, 77030, United States
University of Texas M.D. Anderson CCOP Research Base
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

90

Study ID:

NCT00008411

Recruitment Status:

Completed

Sponsor:


M.D. Anderson Cancer Center

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