Breast Neoplasm Malignant Female
Conditions
Brief summary
Continued access to treatment for subjects who continue benefit from therapy with gedatolisib in combination with palbociclib, and fulvestrant or letrozole.
Detailed description
The primary purpose of this study is to provide continuing access to treatment for subjects who continue benefit from therapy with gedatolisib in combination with palbociclib, and fulvestrant or letrozole.
Interventions
DRUGGedatolisib
Gedatolisib is a potent, reversible dual inhibitor that selectively targets phosphoinositide 3 kinase (PI3K) and mammalian target of rapamycin (mTOR) in biochemical and cellular assays.
Sponsors
Celcuity Inc
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Inclusion criteria
1. Currently enrolled in the B2151009 clinical study and benefiting from treatment with gedatolisib in combination with other therapies as determined by the Investigator 2. Previously demonstrated compliance and are willing and able to comply with scheduled visits, treatment plans, and other study procedures 3. No evidence of progressive disease, as determined by the Investigator 4. Provide written informed consent prior to enrolling and receiving treatment
Exclusion criteria
1. Permanently discontinued from treatment in Study B2151009, or discontinued from Study B2151009 for any reason 2. Women who are pregnant, intend to become pregnant, or nursing
Countries
United States
Contacts
Primary ContactNadene Zack, MS
Outcome results
None listed