Study of AZD2014 and Palbociclib in patients with Estrogen Receptor Positive (ER+) Metastatic Breast Cancer - PASTOR

Study identifier:D2270C00020

ClinicalTrials.gov identifier:NCT02599714

EudraCT identifier:2015-003320-30

CTIS identifier:N/A

Study Complete

Official Title

A Phase I/II Multicenter Study of the Combination of AZD2014 and Palbociclib on a background of Hormonal Therapy in Patients with Locally Advanced/Metastatic Estrogen Receptor Positive Breast Cancer Comprising a Safety, Pharmacokinetic and Preliminary Efficacy Evaluation followed by a Randomized, Double-Blind, Placebo-controlled, Parallel Group Extension (PASTOR).

Medical condition

Advanced and Metastatic Breast Cancer

Phase

Phase 1

Healthy volunteers

No

Study drug

AZD2014, Palbociclib, Fulvestrant

Sex

Female

Actual Enrollment

54

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 07 Dec 2015
Primary Completion Date: 30 Mar 2018
Study Completion Date: 23 Nov 2023

Study design

Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 May 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria