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

• Status: Active, not recruiting
• Trial end date: 2021-12-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cyclophosphamide; Docetaxel; Doxorubicin; Liposomal doxorubicin; Paclitaxel; Trastuzumab

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