Anastrozole, Palbociclib, Trastuzumab and Pertuzumab in HR-positive, HER2-positive Metastatic Breast
Status:
Recruiting
Trial end date:
2023-07-01
Target enrollment:
Participant gender:
Summary
This is a multicenter, phase I/II trial of anastrozole, palbociclib, trastuzumab, and
pertuzumab is proposed as first-line therapy in metastatic hormone receptor-positive,
HER2-positive breast cancer patients. In this phase I/II clinical trial, the researchers aim
to establish the safety and efficacy of dual HER2 therapy in combination with palbociclib and
anastrozole, which represents a novel and all biologic approach to the treatment of HR+,
HER2+ metastatic breast cancer. Additionally, the researchers aim to examine potential
biomarkers of response to palbociclib including cyclin D1, cyclin E1 and cyclin E2 expression
levels, CDK 2, 4, and 6 levels, phosphorylated retinoblastoma expression and p16 levels. The
researchers intend to use RNA sequencing to assess for other predictors of response in an
unbiased manner to see if this correlates with inhibition of Ki-67 and phosphorylated
retinoblastoma expression as well as evaluate for potential mechanisms of resistance.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborators:
Herbert Irving Comprehensive Cancer Center New York University Langone Medical Center NYU Langone Health Weill Medical College of Cornell University