To: Roy Glen who wrote (11660 ) 11/25/1997 5:52:00 AM From: Henry Niman Respond to of 32384
Roy, The study sounds like the PFE trial, but I think that the number of participating sites is much larger. PFE has indicated that they plan to file an NDA next year. LGND would get milestone payments for filing and approval. Once Droloxifene goes on sale, LGND would get 1% of worldwide sales until Droloxifene is approved for another indication (such as osteoporosis). Then the rate would increase to 3% of all sales, including breast canccer. Here's a description of the trial: Summary: Study of an investigational hormonal treatment, DROLOXIFENE, for advanced breast cancer This is a phase III multi-center, randomized, double-blind trial being conducted in patients with locally advanced or metastatic breast cancer. The objective of the study is to determine if an investigational drug, DROLOXIFENE, will arrest or reverse tumor spread when compared with the standard therapy, tamoxifen. Study drug is taken orally once each day and provided free by the sponsor. Patients will be treated until there is evidence of progressive disease or, once the blind is broken, until the drug they are taking is commercially available. Eligible patients must meet at least the following criteria: Be a pre- or post-menopausal woman Have locally advanced or metastatic breast cancer (cancer has spread to the chest wall, skin, bone or internal organs). The cancer can be locally advanced or metastatic at the time of diagnosis, or it can be recurrent cancer, appearing after adjuvant hormonal treatment or adjuvant chemotherapy Have a tumor that tests positive for estrogen and/or progesterone receptors Have had no thromboembolic events (problems with abnormal blood clot formation) in past 6 months Not currently be taking anticoagulants or daily high-dose steroids If adjuvant hormonal or chemotherapy was given, it must have terminated more than one year ago (for hormonal) or more than four weeks ago (for chemo) Must not have had any hormonal or chemotherapy for advanced disease Must not have any severe or uncontrolled disease (other than the breast cancer) Be able to swallow oral tablets Contact the center below for more information. Contact: Peggy Kosonen, RN, OCN, Study Contact Hematology/Oncology P.C. Stamford, CT 06902 Telephone: 203-323-8944