NeuVax™ + Herceptin®, HER2 1+ 2+
Disease: Breast Cancer
Status: Enrolling Patients
Trial Design: Phase 2b
Of the women diagnosed each year with breast cancer, only about 25% are high over-expressors of HER2, or IHC 3+. This Phase 2b trial targets the approximately 50%-60% of these women who are HER2 low to intermediate (IHC 1+/2+ or FISH < 2.0) and achieve remission with current standard of care, but have no available HER2-targeted adjuvant treatment options to maintain their disease-free status. The combination of trastuzumab and NeuVax has been shown preclinically and in a pilot study to be synergistic. This is a randomized, multicenter, investigator-sponsored, 300 patient Phase 2b clinical trial. It is currently enrolling HER2 1+ and 2+ node positive, and high-risk node negative patients to study NeuVax in combination with Herceptin® (trastuzumab; Genentech/Roche). The endpoint is Disease Free Survival.
This investigator-sponsored trial is a clinical collaboration between Galena, Genentech/Roche, and the Henry M. Jackson Foundation.
About the disease
According to the National Cancer Institute, over 230,000 women in the U.S. are diagnosed with breast cancer annually. Breast Cancer forms in tissues of the breast. The most common type of breast cancer is ductal carcinoma, which begins in the lining of the milk ducts (thin tubes that carry milk from the lobules of the breast to the nipple). Another type of breast cancer is lobular carcinoma, which begins in the lobules (milk glands) of the breast. Invasive breast cancer is breast cancer that has spread from where it began in the breast ducts or lobules to surrounding normal tissue. Breast cancer occurs in both men and women, although male breast cancer is rare.
*NeuVax™ is an investigational product. Efficacy has not been established. Herceptin® is a registered trademark of Genentech.