deltatrials
Active Not Recruiting INTERVENTIONAL NCT03742102

A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer (BEGONIA)

A Phase IB/II, 2-stage, Open-label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab (MEDI4736) + Paclitaxel and Durvalumab (MEDI4736) in Combination With Novel Oncology Therapies With or Without Paclitaxel for First-line Metastatic Triple Negative Breast Cancer

Sponsor: AstraZeneca

Conditions Triple Negative Breast Neoplasms
Interventions Capivasertib Datopotamab deruxtecan Durvalumab Oleclumab Paclitaxel Trastuzumab deruxtecan
Updated 59 times since 2018 Last updated: Apr 22, 2026 Started: Dec 21, 2018 Primary completion: Nov 29, 2024 Completion: Feb 26, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Triple Negative Breast Neoplasms, this trial is ongoing. The trial is conducted by AstraZeneca and has accumulated 59 data snapshots since 2018. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Study Description(click to expand)

This is a Phase IB/II, 2-stage, open-label, multicenter study to determine the efficacy and safety of durvalumab in combination with novel oncology therapies (i.e. therapies designed for immune modulation) with or without paclitaxel and durvalumab + paclitaxel as first-line treatment in patients with metastatic triple negative breast cancer (TNBC). The study is designed to concurrently evaluate potential novel treatment combinations with clinical promise using a 2-stage approach. The study will use a Simon 2-Stage design to evaluate which cohorts may proceed to expansion. Part 1 is a Phase IB study of safety and initial efficacy, and Part 2 may expand patient enrollment if adequate efficacy signal is observed in Part 1. The treatment regimens evaluated in Part 2 will depend on the evaluation of safety and efficacy outcomes in Part 1.

This is a Phase IB/II, 2-stage, open-label, multicenter study to determine the efficacy and safety of durvalumab in combination with novel oncology therapies (i.e. therapies designed for immune modulation) with or without paclitaxel and durvalumab + paclitaxel as first-line treatment in patients with metastatic triple negative breast cancer (TNBC). The study is designed to concurrently evaluate potential novel treatment combinations with clinical promise using a 2-stage approach. The study will use a Simon 2-Stage design to evaluate which cohorts may proceed to expansion.

Part 1 is a Phase IB study of safety and initial efficacy, and Part 2 may expand patient enrollment if adequate efficacy signal is observed in Part 1. The treatment regimens evaluated in Part 2 will depend on the evaluation of safety and efficacy outcomes in Part 1.

Status Flow

~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshot~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshot~Feb 2019 – ~Apr 2019 · 59 days · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Aug 2019 · 2 months · monthly snapshot~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Nov 2019 · 2 months · monthly snapshot~Nov 2019 – ~Jan 2020 · 2 months · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jun 2020 · 31 days · monthly snapshot~Jun 2020 – ~Jul 2020 · 30 days · monthly snapshot~Jul 2020 – ~Aug 2020 · 31 days · monthly snapshot~Aug 2020 – ~Oct 2020 · 2 months · monthly snapshot~Oct 2020 – ~Dec 2020 · 2 months · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Nov 2021 · 31 days · monthly snapshot~Nov 2021 – ~Jan 2022 · 2 months · monthly snapshot~Jan 2022 – ~Feb 2022 · 31 days · monthly snapshot~Feb 2022 – ~Apr 2022 · 59 days · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Feb 2023 · 5 months · monthly snapshot~Feb 2023 – ~Apr 2023 · 59 days · monthly snapshot~Apr 2023 – ~Jun 2023 · 2 months · monthly snapshot~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshot~Jul 2023 – ~Aug 2023 · 31 days · monthly snapshot~Aug 2023 – ~Sep 2023 · 31 days · monthly snapshot~Sep 2023 – ~Oct 2023 · 30 days · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Feb 2024 · 3 months · monthly snapshot~Feb 2024 – ~Mar 2024 · 29 days · monthly snapshot~Mar 2024 – ~Apr 2024 · 31 days · monthly snapshot~Apr 2024 – ~May 2024 · 30 days · monthly snapshot~May 2024 – ~Jun 2024 · 31 days · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Dec 2024 · 3 months · monthly snapshot~Dec 2024 – ~Feb 2025 · 2 months · monthly snapshot~Feb 2025 – ~Jul 2025 · 5 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 – ~Apr 2026 · 3 months · monthly snapshotApr 28, 2026 – present · 2 months · daily API

Change History

59 versions recorded

  1. Apr 28, 2026 — Present [daily]

    Active Not Recruiting

    Phase: PHASE1/PHASE2 → None

  2. Feb 2026 — Apr 2026 [monthly]

    Active Not Recruiting PHASE1/PHASE2

  3. Dec 2025 — Feb 2026 [monthly]

    Active Not Recruiting PHASE1/PHASE2

  4. Nov 2025 — Dec 2025 [monthly]

    Active Not Recruiting PHASE1/PHASE2

  5. Sep 2025 — Nov 2025 [monthly]

    Active Not Recruiting PHASE1/PHASE2

▶ Show 54 earlier versions

  1. Jul 2025 — Sep 2025 [monthly]

    Active Not Recruiting PHASE1/PHASE2

  2. Feb 2025 — Jul 2025 [monthly]

    Active Not Recruiting PHASE1/PHASE2

  3. Dec 2024 — Feb 2025 [monthly]

    Active Not Recruiting PHASE1/PHASE2

  4. Sep 2024 — Dec 2024 [monthly]

    Active Not Recruiting PHASE1/PHASE2

  5. Aug 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE1/PHASE2

    Status: Recruiting → Active Not Recruiting

  6. Jul 2024 — Aug 2024 [monthly]

    Recruiting PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  7. Jun 2024 — Jul 2024 [monthly]

    Recruiting PHASE1_PHASE2

  8. May 2024 — Jun 2024 [monthly]

    Recruiting PHASE1_PHASE2

  9. Apr 2024 — May 2024 [monthly]

    Recruiting PHASE1_PHASE2

  10. Mar 2024 — Apr 2024 [monthly]

    Recruiting PHASE1_PHASE2

  11. Feb 2024 — Mar 2024 [monthly]

    Recruiting PHASE1_PHASE2

  12. Nov 2023 — Feb 2024 [monthly]

    Recruiting PHASE1_PHASE2

  13. Oct 2023 — Nov 2023 [monthly]

    Recruiting PHASE1_PHASE2

  14. Sep 2023 — Oct 2023 [monthly]

    Recruiting PHASE1_PHASE2

  15. Aug 2023 — Sep 2023 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Active Not Recruiting → Recruiting

  16. Jul 2023 — Aug 2023 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  17. Jun 2023 — Jul 2023 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  18. Apr 2023 — Jun 2023 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  19. Feb 2023 — Apr 2023 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  20. Sep 2022 — Feb 2023 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Status: Recruiting → Active Not Recruiting

  21. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE1_PHASE2

  22. Jun 2022 — Jul 2022 [monthly]

    Recruiting PHASE1_PHASE2

  23. May 2022 — Jun 2022 [monthly]

    Recruiting PHASE1_PHASE2

  24. Apr 2022 — May 2022 [monthly]

    Recruiting PHASE1_PHASE2

  25. Feb 2022 — Apr 2022 [monthly]

    Recruiting PHASE1_PHASE2

  26. Jan 2022 — Feb 2022 [monthly]

    Recruiting PHASE1_PHASE2

  27. Nov 2021 — Jan 2022 [monthly]

    Recruiting PHASE1_PHASE2

  28. Oct 2021 — Nov 2021 [monthly]

    Recruiting PHASE1_PHASE2

  29. Sep 2021 — Oct 2021 [monthly]

    Recruiting PHASE1_PHASE2

  30. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE1_PHASE2

  31. May 2021 — Jun 2021 [monthly]

    Recruiting PHASE1_PHASE2

  32. Apr 2021 — May 2021 [monthly]

    Recruiting PHASE1_PHASE2

  33. Mar 2021 — Apr 2021 [monthly]

    Recruiting PHASE1_PHASE2

  34. Feb 2021 — Mar 2021 [monthly]

    Recruiting PHASE1_PHASE2

  35. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE1_PHASE2

  36. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE1_PHASE2

  37. Oct 2020 — Dec 2020 [monthly]

    Recruiting PHASE1_PHASE2

  38. Aug 2020 — Oct 2020 [monthly]

    Recruiting PHASE1_PHASE2

  39. Jul 2020 — Aug 2020 [monthly]

    Recruiting PHASE1_PHASE2

  40. Jun 2020 — Jul 2020 [monthly]

    Recruiting PHASE1_PHASE2

  41. May 2020 — Jun 2020 [monthly]

    Recruiting PHASE1_PHASE2

  42. Apr 2020 — May 2020 [monthly]

    Recruiting PHASE1_PHASE2

  43. Mar 2020 — Apr 2020 [monthly]

    Recruiting PHASE1_PHASE2

  44. Feb 2020 — Mar 2020 [monthly]

    Recruiting PHASE1_PHASE2

  45. Jan 2020 — Feb 2020 [monthly]

    Recruiting PHASE1_PHASE2

  46. Nov 2019 — Jan 2020 [monthly]

    Recruiting PHASE1_PHASE2

  47. Sep 2019 — Nov 2019 [monthly]

    Recruiting PHASE1_PHASE2

  48. Aug 2019 — Sep 2019 [monthly]

    Recruiting PHASE1_PHASE2

  49. Jun 2019 — Aug 2019 [monthly]

    Recruiting PHASE1_PHASE2

  50. May 2019 — Jun 2019 [monthly]

    Recruiting PHASE1_PHASE2

  51. Apr 2019 — May 2019 [monthly]

    Recruiting PHASE1_PHASE2

  52. Feb 2019 — Apr 2019 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Not Yet Recruiting → Recruiting

  53. Jan 2019 — Feb 2019 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

  54. Dec 2018 — Jan 2019 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

    First recorded

Eligibility Summary

This study is designed to determine the efficacy and safety of durvalumab in combination with novel oncology therapies with or without paclitaxel and durvalumab + paclitaxel for first-line metastatic triple negative breast cancer

Contact Information

Sponsor contact:
  • AstraZeneca
Data source: ClinicalTrials.gov

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

Study Locations

Boston, United States , Boston, United States , Cambridge, United Kingdom , Columbia, United States , Dallas, United States , Gdansk, Poland , Grand Rapids, United States , Greenfield Park, Canada , Kaohsiung City, Taiwan , Kelowna, Canada and 22 more locations