Overview

Study of AZD2014 and Palbociclib in Patients With Estrogen Receptor Positive (ER+) Metastatic Breast Cancer

Status:
Active, not recruiting

Trial end date:
2021-12-31

Target enrollment:

Participant gender:

Summary

This dose finding/extension study was designed originally to consist of three parts: Part A was intended to identify the MTD of the AZD2014/ palbociclib combination on a background of fulvestrant (referred to as the triplet) in postmenopausal women with locally advanced/ metastatic estrogen receptor positive (ER+) breast cancer. Part B was to further characterize safety, tolerability, PK, and preliminary efficacy in single-arm dose expansion groups. Part C was to be a Phase 2, randomized, double-blind, extension comparing the triplet and doublet combinations. Part C was deleted from the protocol and was not performed.

Phase:

Phase 1

Details

Lead Sponsor:

AstraZeneca

Collaborator:

SCRI Development Innovations, LLC

Treatments:

Estradiol
Estrogens
Fulvestrant
Palbociclib