Study of AZD2014 and Palbociclib in Patients With Estrogen Receptor Positive (ER+) Metastatic Breast Cancer
Completed · Phase 1
Conditions studied: Advanced and Metastatic Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT02599714
- Run by
- AstraZeneca
- People needed
- 54
- Starts
- 2015-12-07
- Expected to finish
- 2023-11-23
- Last updated by the study team
- 2024-06-06
Who can join
Age: 18 and older, up to 130. Sex: female. Healthy volunteers: not accepted.
Where it is running
- Research Site — Encinitas, California, United States
- Research Site — Sarasota, Florida, United States
- Research Site — Detroit, Michigan, United States
- Research Site — Nashville, Tennessee, United States
- Research Site — Milwaukee, Wisconsin, United States
- Research Site — Liverpool, United Kingdom
- Research Site — London, United Kingdom
Full record on ClinicalTrials.gov
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