Posts Tagged ‘anti-estrogen therapy’

STRIDE Breast Cancer Study Testing Stimuvax Cancer Vaccine Open at CORT

September 4, 2009

CORT has opened the STRIDE study for first-line treatment of metastatic, hormone-receptor positive breast cancer.  The study will test standard anti-estrogen therapy in combination with a vaccine placebo, versus standard anti-estrogen therapy with the Stimuvax cancer vaccine.  The press release regarding this study is posted below.

For more information about this study, or to schedule appointments for evaluation and treatment of metastatic breast cancer, visit the CORT website at www.CORTPA.com, or call 972-566-5588 and ask to speak with a Patient Care Coordinator or CORT Research Nurse. 

STRIDE Press Announcement:

24 Jun 2009 – Merck KGaA announced the initiation of its global Phase III clinical study of the therapeutic cancer vaccine Stimuvax® (BLP25 liposome vaccine, L-BLP25) in patients with advanced, inoperable breast cancer. The STRIDEa study will determine if Stimuvax can extend progression-free survival in patients treated with hormonal therapy who have hormone receptor-positive, locally advanced, recurrent or metastatic breast cancer. Overall survival, quality of life, tumor response and safety will also be assessed in this study. The STRIDE study will be supervised by an expert Steering Committee and is sponsored by Merck, which is leading the development of Stimuvax.
STRIDE will enroll more than 900 patients with advanced breast cancer at an estimated 180 sites in over 30 countries – within North America, Europe, Asia and Australia; the Principal Investigator is Dr Lawrence Shulman, Chief Medical Officer and Senior Vice President for Medical Affairs, Dana-Farber Cancer Institute, Boston, USA.
 
Stimuvax is an investigational therapeutic cancer vaccine designed to stimulate the body’s immune system to identify and target cancer cells that express MUC1, an antigen commonly expressed in breast cancer as well as in other common cancer types such as non-small cell lung cancer (NSCLC), multiple myeloma, and colorectal, prostate and ovarian cancers.
 
The Phase III program for Stimuvax was initiated following results from a randomized Phase IIb study of 171 patients with inoperable stage IIIb NSCLC, in which Stimuvax showed a trend towards extending median overall survival from 13.3 months for patients receiving best supportive care (BSC) to 30.6 months for patients receiving Stimuvax plus BSC. Reported side effects included mild-to-moderate flu-like symptoms, gastrointestinal disturbances and mild injection-site reactions. A further long-term safety analysis in 16 patients receiving prolonged treatment with Stimuvax from 2 to 8.2 years showed the most common treatment-related adverse events were injection-site reactions (ISRs) with no evidence of autoimmune reactions. These data also show that the occurrence of ISRs decreased with long-term therapy (>1 year).