Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-18-073
Prinicipal Investigator
Truica, Cristina
Phase
Phase II
Age Group
Adult
Scope
National
Secondary Protocol No.
J15212
Title
Phase II Palbociclib with Fulvestrant in Individuals with Hormone Receptive Positive HER2 Negative Metastatic Breast Cancer who progressed on treatment with Palbociclib + an Aromatase Inhibitor
Objective
Primary
To estimate progression-free survival (PFS) of palbociclib and fulvestrant in women and men with ER/PR-positive, HER2-negative MBC who progressed on a palbociclib and an AI
To determine the prevalence of ESR1 and PI3K mutations in tissue and in ptDNA in women and men with ER/PR-positive, HER2-negative MBC who progressed on a palbociclib and an AI
Secondary
To evaluate the PFS in individuals with or without ESR1 mutations when treated with palbociclib and fulvestrant
To evaluate the PFS in individuals with or without P13K mutations when treated with palbociclib and fulvestrant
To correlate mutation burden, characterized by the number of exome mutations and ptDNA, with PFS and overall survival (OS)
To describe measures of disease control, including response rate (RR) and clinical benefit rate (CBR)
To assess the safety and tolerability of palbociclib and fulvestrant in individuals who progressed on prior palbociclib and an AI
To determine change in CTC enumeration, CTC-ER status, and CTC-Ki67 in individuals when treated with palbociclib and fulvestrant
To correlate CTC enumeration, CTC-ER status and CTC-Ki67 with PFS, RR, CBR, and OS
To determine if baseline CTC-ESR1 and CTC-other ER-related genes are mutated in individuals progressing on AI and palbociclib therapy
To compare CTC-ESR1 and cell free circulating plasma tumor ESR1 mutations
Exploratory
To describe alterations in genes and gene products relevant to cell cycle, drug targets, tumor sensitivity and resistance
To systematically identify novel protein kinases activated in biopsies
To conduct additional correlative studies to determine associations between specific kinases identified and response
Applicable Disease Sites
Breast
Status
Open
Participating Institutions
Hershey Medical Center