Study

EORTC-1307

A phase III, randomized, open label, multicenter, controlled trial of niraparib versus physician’s choice in previously-treated, HER2 negative, germline BRCA mutation-positive breast cancer patients.

Study documentation Back to result

Trial Status

All trial activities ended

Dates

Date of activation: 31-Oct-2013
Date Step1 close: 29-Mar-2017
Date Step2 close: 29-Mar-2017

Data management at EORTC

Yes

Design

Phase 3
Randomized open label

Targeted Sample size

EORTC Groups: 50 - All Groups: 306

Protocol summary

http://clinicaltrials.gov/study/NCT01905592

NCT number

NCT01905592

EudraCT

2013-000684-85

Study

EORTC-1307-BRAVO

A phase III, randomized, open label, multicenter, controlled trial of niraparib versus physician’s choice in previously-treated, HER2 negative, germline BRCA mutation-positive breast cancer patients.

Study documentation Back to result

Research Projects

RP-2560-TRIAL-GEN

Reforming Clinical TRIAL Eligibility for Improved GENeralisability – A Multifaceted-Study on EORTC Protocols, Investigator's Survey, Screening Data, and Real-world Evidence