Novel Strategies in the Management of Progressive BRCA-Mutated Breast Cancer

This program will include a discussion of off-label treatment and investigational agents not approved by the FDA for use in the US, and data that were presented in abstract form. These data should be considered preliminary until published in a peer-reviewed journal.

Overview

BRCA1/2 Testing Criteria

BRCA1/2 Testing Criteria (cont)

DNA Damage Repair Mechanisms

Pathways to Synthetic Lethality

Phase 1 Trials in Patients With Germline BRCA-Mutated Breast Cancer

Phase 1 Trials in Patients With Germline BRCA-Mutated Breast Cancer (cont)

Randomized Phase 2 Study of Gemcitabine/Carboplatin With and Without Iniparib

Randomized Phase 2 Study of Gemcitabine/Carboplatin With and Without Iniparib (cont)

BROCADE 2 Study: Design

BROCADE 2 Study: Results

BrighTNess Study: TNBC and Continuous Dosing

BrighTNess Study: Results

BrighTNess Study: Conclusions

ABRAZO Trial Talazoparib Phase 2 in gBRCA+ MBC

ABRAZO Trial: Primary Efficacy Endpoint ORR by Independent Radiologist Facility

EMBRACA Phase 3 Study

EMBRACA Phase 3 Study (cont)

OlympiAD Study Design

OlympiAD Study: Primary Endpoint PFS by BICR

OlympiAD Study: Time to Second Progression or Death (PFS2) by Investigator Assessment

OlympiAD Study: AEs

OlympiAD: AEs (cont)

Clinical Implications

Challenges and Unanswered Questions