deltatrials
Terminated PHASE2 INTERVENTIONAL 3-arm NCT04570956

Oral Tamoxifen vs. TamGel vs. Control in Women With Atypical Hyperplasia, Lobular Carcinoma In Situ, or Increased Breast Cancer Risk

Phase IIB Randomized Trial of Oral Tamoxifen vs. Topical 4-hydroxytamoxifen Gel vs. Control in Women With Atypical Hyperplasia, Lobular Carcinoma in Situ, or Increased Breast Cancer Risk

Sponsor: Mayo Clinic

Conditions Breast Atypical Hyperplasia Breast Atypical Lobular Hyperplasia Breast Carcinoma Breast Lobular Carcinoma in Situ
Interventions Placebo Questionnaire Administration Tamoxifen Topical 4-OHT( 4-hydroxytamoxifen)gel 4 mg/each breast/day
Updated 20 times since 2020 Last updated: Jan 21, 2026 Started: Jul 26, 2021 Primary completion: Oct 15, 2024 Completion: Oct 15, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

grant and funding expired

Other terminated trials from Mayo Clinic

See all terminations from Mayo Clinic

This PHASE2 trial investigates Breast Atypical Hyperplasia and Breast Atypical Lobular Hyperplasia and is currently terminated or withdrawn. Mayo Clinic leads this study, which shows 20 recorded versions since 2021 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Jun 2021 · 3 months · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Nov 2022 · 13 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Feb 2023 · 2 months · monthly snapshot~Feb 2023 – ~May 2023 · 3 months · monthly snapshot~May 2023 – ~Jun 2023 · 31 days · monthly snapshot~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshot~Jul 2023 – ~Jan 2024 · 6 months · monthly snapshot~Jan 2024 – ~Mar 2024 · 2 months · monthly snapshot~Mar 2024 – ~Jul 2024 · 4 months · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Jan 2025 · 4 months · monthly snapshot~Jan 2025 – ~Feb 2026 · 13 months · monthly snapshot~Feb 2026 – present · 5 months · monthly snapshot

Change History

20 versions recorded

  1. Feb 2026 — Present [monthly]

    Terminated PHASE2

    Status: Active Not Recruiting → Terminated

  2. Jan 2025 — Feb 2026 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  3. Sep 2024 — Jan 2025 [monthly]

    Recruiting PHASE2

  4. Aug 2024 — Sep 2024 [monthly]

    Recruiting PHASE2

  5. Jul 2024 — Aug 2024 [monthly]

    Recruiting PHASE2

▶ Show 15 earlier versions

  1. Mar 2024 — Jul 2024 [monthly]

    Recruiting PHASE2

    Phase: PHASE2_PHASE3 → PHASE2

  2. Jan 2024 — Mar 2024 [monthly]

    Recruiting PHASE2_PHASE3

  3. Jul 2023 — Jan 2024 [monthly]

    Recruiting PHASE2_PHASE3

  4. Jun 2023 — Jul 2023 [monthly]

    Recruiting PHASE2_PHASE3

  5. May 2023 — Jun 2023 [monthly]

    Recruiting PHASE2_PHASE3

  6. Feb 2023 — May 2023 [monthly]

    Recruiting PHASE2_PHASE3

    Status: Suspended → Recruiting

  7. Dec 2022 — Feb 2023 [monthly]

    Suspended PHASE2_PHASE3

    Status: Recruiting → Suspended

  8. Nov 2022 — Dec 2022 [monthly]

    Recruiting PHASE2_PHASE3

  9. Oct 2021 — Nov 2022 [monthly]

    Recruiting PHASE2_PHASE3

    Status: Not Yet Recruiting → Recruiting

  10. Sep 2021 — Oct 2021 [monthly]

    Not Yet Recruiting PHASE2_PHASE3

  11. Jun 2021 — Sep 2021 [monthly]

    Not Yet Recruiting PHASE2_PHASE3

  12. Mar 2021 — Jun 2021 [monthly]

    Not Yet Recruiting PHASE2_PHASE3

  13. Jan 2021 — Mar 2021 [monthly]

    Not Yet Recruiting PHASE2_PHASE3

  14. Nov 2020 — Jan 2021 [monthly]

    Not Yet Recruiting PHASE2_PHASE3

  15. Oct 2020 — Nov 2020 [monthly]

    Not Yet Recruiting PHASE2_PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Mayo Clinic
  • National Cancer Institute (NCI)
Data source: Mayo Clinic

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

Study Locations