Phase I Study of Combination of Gedatolisib With Palbociclib and Faslodex in Patients With ER+/HER2- Breast Cancer

PHASE1UnknownINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

January 31, 2016

Primary Completion Date

February 15, 2022

Study Completion Date

March 15, 2022

Conditions
Breast Cancer
Interventions
DRUG

Gedatolisib

adenosine triphosphate (ATP) competitive, highly selective and potent inhibitor of pan-class I isoform phosphatidylinositol-4,5-bisphosphate 3-kinase (PI3-K)

DRUG

Faslodex

Faslodex® (Fulvestrant) is a potent anti-estrogen drug that binds and degrades estrogen receptors (ERs).

DRUG

Palbociclib

Palbociclib (Ibrance®) is an orally active highly selective reversible inhibitor of cyclin-dependent kinase (CDK) 4 and CDK 6.

DRUG

Zoladex

Zoladex is used to render menopause in pre-menopausal subjects, given once every 28 days starting at least 14 days prior to treatment.

Trial Locations (2)

10469

Hoffman Oncology, The Bronx

90027

California Research Institute, Los Angeles

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

DSCS CRO

INDUSTRY

lead

Hoffman Oncology

OTHER