NCT02561832View on ClinicalTrials.gov

A Phase I, Open-Label, 2 Part Multicentre Study to Assess the Safety and Efficacy of Olaparib in Combination With Carboplatin in Patients With Advanced HER-2 Negative Breast Cancer

PHASE1TerminatedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

November 6, 2015

Primary Completion Date

September 30, 2016

Study Completion Date

February 1, 2017

Conditions
Breast Cancer
Interventions
DRUG

Olaparib

tablets taken orally twice daily

DRUG

Carboplatin

intravenous injections on day one of each cycle

DRUG

Anthracycline

The choice of anthracycline and cyclophosphamide (AC) regimen in Part B will be up to local Investigator following international guidelines

DRUG

Cyclophosphamide

The choice of anthracycline and cyclophosphamide (AC) regimen in Part B will be up to local Investigator following international guidelines

Trial Locations (7)

10065

Research Site, New York

11794

Research Site, Stony Brook

28034

Research Site, Madrid

28050

Research Site, Madrid

46010

Research Site, Valencia

50009

Research Site, Zaragoza

08035

Research Site, Barcelona

Sponsors

Lead Sponsor

AstraZeneca
All Listed Sponsors
lead

AstraZeneca

INDUSTRY