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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.

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Presentation on theme: "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."— Presentation transcript:

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

2 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.

3 Overview

4 BRCA1/2 Testing Criteria

5 BRCA1/2 Testing Criteria (cont)

6 DNA Damage Repair Mechanisms

7 Pathways to Synthetic Lethality

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

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

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

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

12 BROCADE 2 Study: Design

13 BROCADE 2 Study: Results

14 BrighTNess Study: TNBC and Continuous Dosing

15 BrighTNess Study: Results

16 BrighTNess Study: Conclusions

17 ABRAZO Trial Talazoparib Phase 2 in gBRCA+ MBC

18 ABRAZO Trial: Primary Efficacy Endpoint ORR by Independent Radiologist Facility

19 EMBRACA Phase 3 Study

20 EMBRACA Phase 3 Study (cont)

21 OlympiAD Study Design

22 OlympiAD Study: Primary Endpoint PFS by BICR

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

24 OlympiAD Study: AEs

25 OlympiAD: AEs (cont)

26 Clinical Implications

27 Challenges and Unanswered Questions

28


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