deltatrials
Active Not Recruiting PHASE2 INTERVENTIONAL 3-arm NCT04584255

Niraparib + Dostarlimab In BRCA Mutated Breast Cancer

A Phase II Study of Niraparib With Dostarlimab Therapy as Neoadjuvant Treatment for Patients With BRCA-mutated Breast Cancer

Sponsor: Dana-Farber Cancer Institute

Conditions Breast Cancer Deleterious PALB2 Gene Mutation Germline BRCA1 Gene Mutation Germline BRCA2 Gene Mutation HER2-negative Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage III Breast Cancer
Interventions Dostarlimab Niraparib
Updated 18 times since 2020 Last updated: Jul 24, 2025 Started: Dec 18, 2020 Primary completion: Jul 1, 2025 Completion: Jul 17, 2029
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Breast Cancer and Deleterious PALB2 Gene Mutation and is currently ongoing. Dana-Farber Cancer Institute leads this study, which shows 18 recorded versions since 2020 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Jun 2021 · 4 months · monthly snapshot~Jun 2021 – ~Dec 2021 · 6 months · monthly snapshot~Dec 2021 – ~Apr 2022 · 4 months · monthly snapshot~Apr 2022 – ~Jul 2022 · 3 months · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Dec 2022 · 3 months · monthly snapshot~Dec 2022 – ~Mar 2023 · 3 months · monthly snapshot~Mar 2023 – ~Sep 2023 · 6 months · monthly snapshot~Sep 2023 – ~Nov 2023 · 2 months · monthly snapshot~Nov 2023 – ~Jun 2024 · 7 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~May 2025 · 7 months · monthly snapshot~May 2025 – ~Aug 2025 · 3 months · monthly snapshot~Aug 2025 – present · 13 months · monthly snapshot

Change History

18 versions recorded

  1. Aug 2025 — Present [monthly]

    Active Not Recruiting PHASE2

  2. May 2025 — Aug 2025 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  3. Oct 2024 — May 2025 [monthly]

    Recruiting PHASE2

  4. Sep 2024 — Oct 2024 [monthly]

    Recruiting PHASE2

  5. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE2

▶ Show 13 earlier versions

  1. Jun 2024 — Jul 2024 [monthly]

    Recruiting PHASE2

  2. Nov 2023 — Jun 2024 [monthly]

    Recruiting PHASE2

  3. Sep 2023 — Nov 2023 [monthly]

    Recruiting PHASE2

  4. Mar 2023 — Sep 2023 [monthly]

    Recruiting PHASE2

  5. Dec 2022 — Mar 2023 [monthly]

    Recruiting PHASE2

  6. Sep 2022 — Dec 2022 [monthly]

    Recruiting PHASE2

  7. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE2

  8. Apr 2022 — Jul 2022 [monthly]

    Recruiting PHASE2

  9. Dec 2021 — Apr 2022 [monthly]

    Recruiting PHASE2

  10. Jun 2021 — Dec 2021 [monthly]

    Recruiting PHASE2

  11. Feb 2021 — Jun 2021 [monthly]

    Recruiting PHASE2

    Status: Not Yet Recruiting → Recruiting

  12. Jan 2021 — Feb 2021 [monthly]

    Not Yet Recruiting PHASE2

  13. Nov 2020 — Jan 2021 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Dana-Farber Cancer Institute
  • GlaxoSmithKline
  • Johns Hopkins University
  • Translational Breast Cancer Research Consortium
Data source: Dana-Farber Cancer Institute

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

Study Locations