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Trial Suggests Synergistic Effects Of Navelbine In Combination With Herceptin.(for metastatic breast cancer treatment)
2002 JAN 17 - (NewsRx.com & NewsRx.net) -- Researchers investigating the combination of Navelbine (vinorelbine tartrate) Injection, a first-line chemotherapy treatment for advanced non-small cell lung cancer, and the monoclonal antibody therapy Herceptin (trastuzumab), reported an overall response rate of 78% in women with HER2-positive metastatic breast cancer.
Results of the Phase II study were presented at the 24th Annual San Antonio, Texas Breast Cancer Symposium, December 13, 2001. Navelbine is not indicated for use in women with metastatic breast cancer.
"The response rate from our multicenter study and a previously reported response rate of 75% from an earlier single-site trial are both very encouraging," said Mohammed Jahanzeb, MD, research director of the Boca Raton Comprehensive Cancer Center and professor of biomedical research at Florida Atlantic University, in reference to a single-center investigation at the Dana-Farber Cancer Institute in Boston.
The Phase II clinical trial investigated the safety and efficacy of Herceptin and Navelbine as first-line therapy, in metastatic breast cancer, for women with tumors that overexpress HER2 protein, a growth-promoting chemical that has been closely linked to a poor prognosis in breast cancer. Nearly a quarter of women with breast cancer have tumors that overexpress HER2. The acquired gene aberration that produces HER2 is associated with more rapid cancer progression and shortened survival.
Forty patients were enrolled in the trial. Weekly intravenous doses of Herceptin and Navelbine were administered over four-week cycles. Thirty-seven patients were evaluated for a response after receiving at least two cycles. A total of four complete responses and 25 partial responses were observed for an overall response rate of 78%. Progression of disease occurred in four patients and four remained stable.
After a cumulative total of 313 cycles, ...
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