Herceptin™ (trastuzumab) in patients who overexpress Her-2 and have failed multiple chemotherapy regimens for advanced breast cancer: a pragmatic study
- G Westman1
© Current Science Ltd 2000
Published: 12 March 2000
This prospective study will include patients who are at least 18 years of age, with a histologically or cytologically confirmed diagnosis of advanced breast cancer (ABC), who have failed or are resistant to treatment with at least two chemotherapy regimens for ABC, and who overexpress HER-2. A maximum of 62 patients are to be included for the detection of an overall response rate of 20% (10-30%, 95% confidence interval).
Her-2 status will be analyzed with immunohistochemistry (Novocastra NCL CB-11, mouse monoclonal antibody). Treatment will be single dose trastuzumab: 4 mg/kg first treatment, and 2 mg/kg thereafter, for at least 10 cycles. Tumor response and side effects will be documented. In a separate protocol bone marrow micrometastasis will be analyzed.
The study started at the end of December 1999. Four patients have been included so far. More data and some results will be presented at the meeting.