Study record managers: refer to the Data Element Definitions if submitting registration or results information. The presence of the following mutations from tumor free DNA will be documented and part of an exploratory analysis:. Talk with your doctor and family members or friends about deciding to join a study.
Miriam Portman. The trial will utilize oral lasofoxifene for advanced breast cancer patients with ESR1 gene mutations. The primary clinical endpoint will be progression-free survival PFS.
In postmenopausal women with low or normal bone mineral density BMDlasofoxifene increased BMD at the lumbar spine and hip and reduced bone turnover markers compared with placebo. In women with postmenopausal osteoporosis, lasofoxifene increased BMD, reduced bone turnover markers, reduced the risk of vertebral and nonvertebral fractures, and decreased the risk of estrogen receptor-positive breast cancer. In postmenopausal women with low bone mass, lasofoxifene improved the signs and symptoms of vulvovaginal atrophy.
It is a naphthalene derivative marketed for prevention and treatment of osteoporosis and for the treatment of vaginal atrophy. It was initially developed as Oporia by Pfizer as a treatment for postmenopausal osteoporosis and vaginal atrophy, in which were both rejected for approval by FDA. Later Fablyn was developed as a result of a research collaboration between Pfizer and Ligand Pharmaceuticals with a newly submitted New Drug Application in
The new abstract showed that lasofoxifene, in combination with palbociclib, was more effective than the combination of fulvestrant and palbociclib at reducing primary tumor growth in a mouse intraductal model. The designation allows for the expedited development and review of drugs that treat serious conditions and fill an unmet medical need. Barry Komm, Sermonix chief scientific officer.
Lasofoxifenesold under the brand name Fablynis a nonsteroidal selective estrogen receptor modulator SERM which is marketed by Pfizer in Lithuania and Portugal for the prevention and treatment of osteoporosis and for the treatment of vaginal atrophy  and the result of an exclusive research collaboration with Ligand Pharmaceuticals LGND. It also appears to have had a statistically significant effect of reducing breast cancer in women according to a study published in The Journal of the National Cancer Institute. In postmenopausal women with osteoporosis, lasofoxifene at a dose of 0.
Morial Convention Center in New Orleans. Sermonix, which is currently enrolling patients in a Phase 2 clinical study of lasofoxifene, collaborated with researchers at the University of Chicago on the poster to be presented at ENDO Geoffrey Greene, Ph.
Seventy percent of theU. In the U. Most women with hormone positive breast cancer receive adjuvant endocrine therapy and eventually a large proportion become resistant through acquired resistance and mutations of the estrogen receptor. Lasofoxifene, a potent SERM with binding affinity and activity in mutations of the estrogen receptor, may hold promise for many patients in this area of unmet medical need.