deltatrials
Completed EARLY_PHASE1 INTERVENTIONAL 1-arm NCT03132467

Durvalumab and Tremelimumab Before Surgery in Treating Patients With Hormone Receptor Positive, HER2 Negative Stage II-III Breast Cancer

A Pilot Pre-Surgical Study Evaluating Anti-PD-L1 Antibody (Durvalumab [MEDI4736]) Plus Anti-CTLA-4 Antibody (Tremelimumab) in Patients With Hormone Receptor Positive, HER2 Negative Breast Cancer

Sponsor: M.D. Anderson Cancer Center

Conditions Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage IIA Breast Cancer AJCC v8 Anatomic Stage IIB Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 Anatomic Stage IIIB Breast Cancer AJCC v8 Anatomic Stage IIIC Breast Cancer AJCC v8 Estrogen Receptor Positive HER2/Neu Negative Progesterone Receptor Positive Prognostic Stage II Breast Cancer AJCC v8 Prognostic Stage IIA Breast Cancer AJCC v8 Prognostic Stage IIB Breast Cancer AJCC v8 Prognostic Stage III Breast Cancer AJCC v8 Prognostic Stage IIIA Breast Cancer AJCC v8 Prognostic Stage IIIB Breast Cancer AJCC v8 Prognostic Stage IIIC Breast Cancer AJCC v8
Interventions Durvalumab Tremelimumab
Updated 21 times since 2017 Last updated: May 21, 2024 Started: Jun 13, 2017 Primary completion: Jan 31, 2019 Completion: May 20, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03132467, this EARLY_PHASE1 trial focuses on Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage IIA Breast Cancer AJCC v8 and remains completed. Sponsored by M.D. Anderson Cancer Center, it has been updated 21 times since 2017, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~May 2017 – ~Jul 2017 · 2 months · monthly snapshot~Jul 2017 – ~Jun 2018 · 11 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Nov 2018 · 4 months · monthly snapshot~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Apr 2019 · 4 months · 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 – ~Mar 2020 · 6 months · monthly snapshot~Mar 2020 – ~Jan 2021 · 10 months · monthly snapshot~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshot~Oct 2021 – ~Mar 2022 · 5 months · monthly snapshot~Mar 2022 – ~Sep 2022 · 6 months · monthly snapshot~Sep 2022 – ~Mar 2023 · 6 months · monthly snapshot~Mar 2023 – ~Sep 2023 · 6 months · monthly snapshot~Sep 2023 – ~Mar 2024 · 6 months · monthly snapshot~Mar 2024 – ~Jul 2024 · 4 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 24 months · monthly snapshot

Change History

21 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed EARLY_PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed EARLY_PHASE1

    Status: Active Not Recruiting → Completed

  3. Mar 2024 — Jul 2024 [monthly]

    Active Not Recruiting EARLY_PHASE1

  4. Sep 2023 — Mar 2024 [monthly]

    Active Not Recruiting EARLY_PHASE1

  5. Mar 2023 — Sep 2023 [monthly]

    Active Not Recruiting EARLY_PHASE1

▶ Show 16 earlier versions

  1. Sep 2022 — Mar 2023 [monthly]

    Active Not Recruiting EARLY_PHASE1

  2. Mar 2022 — Sep 2022 [monthly]

    Active Not Recruiting EARLY_PHASE1

  3. Oct 2021 — Mar 2022 [monthly]

    Active Not Recruiting EARLY_PHASE1

  4. Jan 2021 — Oct 2021 [monthly]

    Active Not Recruiting EARLY_PHASE1

  5. Mar 2020 — Jan 2021 [monthly]

    Active Not Recruiting EARLY_PHASE1

  6. Sep 2019 — Mar 2020 [monthly]

    Active Not Recruiting EARLY_PHASE1

  7. Aug 2019 — Sep 2019 [monthly]

    Active Not Recruiting EARLY_PHASE1

  8. Jun 2019 — Aug 2019 [monthly]

    Active Not Recruiting EARLY_PHASE1

  9. May 2019 — Jun 2019 [monthly]

    Active Not Recruiting EARLY_PHASE1

    Status: Recruiting → Active Not Recruiting

  10. Apr 2019 — May 2019 [monthly]

    Recruiting EARLY_PHASE1

  11. Dec 2018 — Apr 2019 [monthly]

    Recruiting EARLY_PHASE1

  12. Nov 2018 — Dec 2018 [monthly]

    Recruiting EARLY_PHASE1

  13. Jul 2018 — Nov 2018 [monthly]

    Recruiting EARLY_PHASE1

  14. Jun 2018 — Jul 2018 [monthly]

    Recruiting EARLY_PHASE1

  15. Jul 2017 — Jun 2018 [monthly]

    Recruiting EARLY_PHASE1

    Status: Not Yet Recruiting → Recruiting

  16. May 2017 — Jul 2017 [monthly]

    Not Yet Recruiting EARLY_PHASE1

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • M.D. Anderson Cancer Center
  • National Cancer Institute (NCI)
Data source: M.D. Anderson Cancer Center

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

Study Locations