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Recruiting PHASE3 INTERVENTIONAL 2-arm NCT05633654

Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)

A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy

Sponsor: Alliance Foundation Trials, LLC.

Updated 28 times since 2022 Last updated: Jan 16, 2026 Started: Dec 12, 2022 Primary completion: Jun 30, 2027 Completion: Aug 31, 2031
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT05633654, this PHASE3 trial focuses on Triple Negative Breast Cancer and remains actively recruiting participants. Sponsored by Alliance Foundation Trials, LLC., it has been updated 28 times since 2022, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~May 2023 · 2 months · monthly snapshot~May 2023 – ~Jun 2023 · 31 days · monthly snapshot~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshot~Jul 2023 – ~Sep 2023 · 2 months · monthly snapshot~Sep 2023 – ~Oct 2023 · 30 days · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Dec 2023 · 30 days · monthly snapshot~Dec 2023 – ~Jan 2024 · 31 days · monthly snapshot~Jan 2024 – ~Feb 2024 · 31 days · monthly snapshot~Feb 2024 – ~Mar 2024 · 29 days · monthly snapshot~Mar 2024 – ~Apr 2024 · 31 days · monthly snapshot~Apr 2024 – ~Jun 2024 · 2 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 – ~Nov 2024 · 31 days · monthly snapshot~Nov 2024 – ~Dec 2024 · 30 days · monthly snapshot~Dec 2024 – ~Feb 2025 · 2 months · monthly snapshot~Feb 2025 – ~May 2025 · 3 months · monthly snapshot~May 2025 – ~Jul 2025 · 2 months · monthly snapshot~Jul 2025 – ~Sep 2025 · 2 months · monthly snapshot~Sep 2025 – ~Nov 2025 · 2 months · monthly snapshot~Nov 2025 – ~Dec 2025 · 30 days · monthly snapshot~Dec 2025 – ~Feb 2026 · 2 months · monthly snapshot~Feb 2026 – present · 3 months · monthly snapshot

Change History

28 versions recorded
  1. Feb 2026 — Present [monthly]

    Recruiting PHASE3

  2. Dec 2025 — Feb 2026 [monthly]

    Recruiting PHASE3

  3. Nov 2025 — Dec 2025 [monthly]

    Recruiting PHASE3

  4. Sep 2025 — Nov 2025 [monthly]

    Recruiting PHASE3

  5. Jul 2025 — Sep 2025 [monthly]

    Recruiting PHASE3

Show 23 earlier versions
  1. May 2025 — Jul 2025 [monthly]

    Recruiting PHASE3

  2. Feb 2025 — May 2025 [monthly]

    Recruiting PHASE3

  3. Dec 2024 — Feb 2025 [monthly]

    Recruiting PHASE3

  4. Nov 2024 — Dec 2024 [monthly]

    Recruiting PHASE3

  5. Oct 2024 — Nov 2024 [monthly]

    Recruiting PHASE3

  6. Sep 2024 — Oct 2024 [monthly]

    Recruiting PHASE3

  7. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE3

  8. Jun 2024 — Jul 2024 [monthly]

    Recruiting PHASE3

  9. Apr 2024 — Jun 2024 [monthly]

    Recruiting PHASE3

  10. Mar 2024 — Apr 2024 [monthly]

    Recruiting PHASE3

  11. Feb 2024 — Mar 2024 [monthly]

    Recruiting PHASE3

  12. Jan 2024 — Feb 2024 [monthly]

    Recruiting PHASE3

  13. Dec 2023 — Jan 2024 [monthly]

    Recruiting PHASE3

  14. Nov 2023 — Dec 2023 [monthly]

    Recruiting PHASE3

  15. Oct 2023 — Nov 2023 [monthly]

    Recruiting PHASE3

  16. Sep 2023 — Oct 2023 [monthly]

    Recruiting PHASE3

  17. Jul 2023 — Sep 2023 [monthly]

    Recruiting PHASE3

  18. Jun 2023 — Jul 2023 [monthly]

    Recruiting PHASE3

  19. May 2023 — Jun 2023 [monthly]

    Recruiting PHASE3

  20. Mar 2023 — May 2023 [monthly]

    Recruiting PHASE3

  21. Feb 2023 — Mar 2023 [monthly]

    Recruiting PHASE3

  22. Jan 2023 — Feb 2023 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  23. Dec 2022 — Jan 2023 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Alliance Foundation Trials, LLC.
  • GBG Forschungs GmbH
  • Gilead Sciences
  • NSABP Foundation Inc
Data source: Gilead Sciences

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