Chemotherapy Plus Monoclonal Antibody Therapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Overexpresses HER2

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

Randomized phase II trial to study the effectiveness of chemotherapy with paclitaxel and the monoclonal antibody trastuzumab followed by chemotherapy in treating women who have stage II or stage IIIA breast cancer that overexpresses HER2. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Paclitaxel; Tamoxifen; Trastuzumab

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed stage II or IIIa (T1-T3, N1-N2, M0) adenocarcinoma of the breast HER2 overexpression (2-3+ by immunochemistry)

• Bilateral breast cancer allowed

• Must have had local breast cancer surgery within past 12 weeks

• Mastectomy or lumpectomy with clear surgical margins AND axillary lymph node dissection with at least 6 nodes removed

• Hormone receptor status: Not specified

PATIENT CHARACTERISTICS:

• Age: 18 and over

• Sex: Female

• WBC at least 3,000/mm3

• Platelet count at least 100,000/mm3

• Hemoglobin at least 9 g/dL

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• Creatinine no greater than 1.5 times ULN

• LVEF at least 50%

• No history of congestive cardiomyopathy

• No congestive heart failure or myocardial infarction within the past 6 months

• No uncontrolled hypertension

• No uncontrolled arrhythmia within the past 6 months

• No other prior malignancy within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix

• No other serious medical illness that would limit survival to less than 2 years

• No psychiatric condition precluding study

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy for breast cancer

• No prior hormonal therapy for breast cancer

• At least one year since prior tamoxifen for chemoprevention (e.g., Breast Cancer Prevention Trial)

• No prior radiotherapy to the breast, chest wall, or regional lymph nodes