Breast Cancer Clinical Trial

Combination Chemotherapy With or Without Trastuzumab in Treating Patients With Stage II or Stage III Breast Cancer

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy with or without trastuzumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.

PURPOSE: This randomized phase II trial is comparing two different regimens of combination chemotherapy given together with or without trastuzumab to see how well they work in treating patients with stage II or stage III breast cancer.

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Full Description

OBJECTIVES:

Primary

Compare 2 neoadjuvant chemotherapy regimens (docetaxel, doxorubicin hydrochloride, and cyclophosphamide [TAC] vs doxorubicin and cyclophosphamide followed by paclitaxel and carboplatin [ACAC]), in terms of toxicities and effectiveness as defined by the pathological complete remission rate, in patients with non HER2/neu overexpressing stage II or III breast cancer.
Evaluate the probability of achieving a pathological complete remission when adding trastuzumab (Herceptin®) to ACAC in the subset of patients with HER2/neu overexpressing stage II or III breast cancer.

Secondary

Identify prognostic and predictive markers of outcome, recurrence, and targets of therapy.

OUTLINE: This is a randomized study. Patients with non HER2/neu overexpressing tumors are randomized to 1 of 2 treatment arms. Patients with HER2/neu overexpressing tumors are assigned to arm III.

Arm I: Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.
Arm II: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive carboplatin IV on day 1 and paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and paclitaxel repeats every 4 weeks for 3 courses.
Arm III: Patients receive chemotherapy as in arm II. They also receive trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin.

Within 4 weeks after completion of chemotherapy with or without trastuzumab (Herceptin®), all patients undergo surgery.

PROJECTED ACCRUAL: A total of 105 patients will be accrued for this study.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically proven infiltrating ductal or lobular breast carcinoma

Stage II or III disease
Inflammatory breast cancer allowed
Hormone-receptor status not specified

PATIENT CHARACTERISTICS:

ECOG performance status < 2
Male or female
Menopausal status not specified (for female patients)
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Bilirubin normal (except for patient's with Gilbert's disease)
Creatinine ≤ 1.2 mg/dL
Creatinine clearance ≥ 70 mL/min
Ejection fraction ≥ 50% on MUGA
No neuropathy ≥ grade 1
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective nonhormonal contraception

No prior malignant disease within the past 5 years, excluding:

Squamous cell or basal cell skin carcinoma
Stage I or in situ cervical carcinoma
No noninvasive (in situ) breast carcinoma within the past 5 years

PRIOR CONCURRENT THERAPY:

At least 5 years since prior antiestrogen treatment for any indication other than breast cancer prevention (tamoxifen, raloxifene, or an aromatase inhibitor)
No prior radiotherapy to the chest wall

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

105

Study ID:

NCT00295893

Recruitment Status:

Unknown status

Sponsor:

City of Hope Medical Center

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There is 1 Location for this study

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City of Hope Medical Center
Duarte California, 91010, United States

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Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

105

Study ID:

NCT00295893

Recruitment Status:

Unknown status

Sponsor:


City of Hope Medical Center

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