Terminated PHASE3 INTERVENTIONAL 2-arm NCT01905592

A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients (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

Sponsor: Breast International Group

Conditions BRCA1 Gene Mutation BRCA2 Gene Mutation Carcinoma of Breast Human Epidermal Growth Factor 2 Negative Carcinoma of Breast Neoplasms, Breast Ovarian Neoplasms

Interventions Physician's choice niraparib

Updated 15 times since 2017 Last updated: Oct 21, 2022 Started: Feb 25, 2014 Primary completion: May 23, 2018 Completion: Oct 26, 2021

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

The study was terminated due to futility.

Other terminated trials from Breast International Group

More terminations from Breast International Group

A PHASE3 clinical study on BRCA1 Gene Mutation and BRCA2 Gene Mutation, this trial is terminated or withdrawn. The trial is conducted by Breast International Group and has accumulated 15 data snapshots since 2014. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

Change History

15 versions recorded

Sep 2025 — Present [monthly]

Terminated PHASE3
Sep 2024 — Sep 2025 [monthly]

Terminated PHASE3
Jul 2024 — Sep 2024 [monthly]

Terminated PHASE3
Dec 2022 — Jul 2024 [monthly]

Terminated PHASE3

Status: Completed → Terminated
Dec 2021 — Dec 2022 [monthly]

Completed PHASE3

Status: Active Not Recruiting → Completed

▶ Show 10 earlier versions

Jan 2021 — Dec 2021 [monthly]

Active Not Recruiting PHASE3
Dec 2020 — Jan 2021 [monthly]

Active Not Recruiting PHASE3
Sep 2020 — Dec 2020 [monthly]

Active Not Recruiting PHASE3
May 2019 — Sep 2020 [monthly]

Active Not Recruiting PHASE3
Jun 2018 — May 2019 [monthly]

Active Not Recruiting PHASE3
Feb 2018 — Jun 2018 [monthly]

Active Not Recruiting PHASE3
Sep 2017 — Feb 2018 [monthly]

Active Not Recruiting PHASE3
May 2017 — Sep 2017 [monthly]

Active Not Recruiting PHASE3

Status: Recruiting → Active Not Recruiting
Feb 2017 — May 2017 [monthly]

Recruiting PHASE3
Jan 2017 — Feb 2017 [monthly]

Recruiting PHASE3

First recorded

Feb 2014

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Breast International Group
European Organisation for Research and Treatment of Cancer - EORTC
Facing Our Risk of Cancer Empowered
Myriad Genetic Laboratories, Inc.
Sarah Cannon
Tesaro, Inc.
US Oncology Research

Data source: Tesaro, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aalst, Belgium , Ancona, Italy , Barcelona, Spain , Bebington, Wirral, United Kingdom , Belfast, United Kingdom , Bordeaux, France , Boston, United States , Brussels, Belgium , Budapest, Hungary , Burgos, Spain and 88 more locations