Trastuzumab in Treating Women With HER2-Positive Early Breast Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: 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. It is not yet known which regimen of trastuzumab is more effective in treating early breast cancer.

PURPOSE: This randomized phase III trial is comparing two trastuzumab regimens to see how well they work in treating women with HER2-positive early breast cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Warwick Medical School
• Treatments: Trastuzumab

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive breast cancer

• No evidence of metastatic disease

• Overexpression of HER2 receptor defined as 3+ or 2+ HER2 positivity measured by fluorescent in situ hybridization (FISH) gene amplification

• Indication for chemotherapy based on the following clinical and histopathological features:

• Receiving or scheduled to receive neoadjuvant chemotherapy

• Time between diagnosis biopsy and start date of chemotherapy should be less than 1 month

• Receiving or scheduled to receive adjuvant chemotherapy

• Completely resected disease, with negative surgical margins (apart from deep margin if full thickness resection)

• Marginally resected disease and/or positive sentinel nodes allowed provided patients undergo completion of surgery (breast and/or axillary clearance) after chemotherapy

• Hormone receptor status known

PATIENT CHARACTERISTICS:

• Menopausal status not specified

• ECOG performance status 0-1

• Adequate bone marrow, hepatic, and renal function

• LVEF normal by ECHO or MUGA

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No clinically significant cardiac abnormalities

• No myocardial infarction within the past 6 months

• No uncontrolled or malignant hypertension

• No history of atrioventricular arrhythmia and/or congestive heart failure (even under medical control), or active second or third degree cardiac block

• No history of allergy to drugs containing polysorbate 20 and the excipient polysorbate 80 (TWEEN 80®) or history of allergy to mouse proteins

• No co-morbidity significantly adding to risks associated with cytotoxic chemotherapy (i.e., severe chronic obstructive pulmonary disease or poorly controlled diabetes)

• No prior diagnosis of malignancy unless managed by surgical treatment only and disease-free for 10 years

• Prior basal cell carcinoma, cervical carcinoma in situ, or ductal carcinoma in situ of the breast allowed if treated by surgery only

• No concomitant medical or psychiatric problems that might preclude completion of treatment or follow-up

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior chemotherapy or radiotherapy

• Concurrent radiotherapy allowed