deltatrials
Terminated PHASE1 INTERVENTIONAL 2-arm NCT05384119

Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer

REVERT- Breast Cancer: Phase 1b/2 Study of the Addition of STAT3 Inhibitor TTI-101 to Reverse Resistance to Palbociclib or Ribociclib Plus Aromatase Inhibitor or Fulvestrant Therapy for Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer

Sponsor: Tvardi Therapeutics, Incorporated

Conditions Breast Cancer
Interventions Aromatase inhibitor (AI) Palbociclib TTI-101 fulvestrant ribociclib
Updated 17 times since 2022 Last updated: Feb 19, 2025 Started: Jan 9, 2023 Primary completion: Apr 25, 2024 Completion: Apr 25, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

The study was terminated prior to Phase 2 due to slow accrual.

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A PHASE1 clinical study on Breast Cancer, this trial is terminated or withdrawn. The trial is conducted by Tvardi Therapeutics, Incorporated and has accumulated 17 data snapshots since 2023. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Feb 2023 · 3 months · monthly snapshot~Feb 2023 – ~May 2023 · 3 months · monthly snapshot~May 2023 – ~Jul 2023 · 2 months · monthly snapshot~Jul 2023 – ~Sep 2023 · 2 months · monthly snapshot~Sep 2023 – ~Nov 2023 · 2 months · monthly snapshot~Nov 2023 – ~Dec 2023 · 30 days · monthly snapshot~Dec 2023 – ~Mar 2024 · 3 months · monthly snapshot~Mar 2024 – ~May 2024 · 2 months · monthly snapshot~May 2024 – ~Jun 2024 · 31 days · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Mar 2025 · 6 months · monthly snapshot~Mar 2025 – ~Sep 2025 · 6 months · monthly snapshot~Sep 2025 – present · 11 months · monthly snapshot

Change History

17 versions recorded

  1. Sep 2025 — Present [monthly]

    Terminated PHASE1

  2. Mar 2025 — Sep 2025 [monthly]

    Terminated PHASE1

    Status: Completed → Terminated · Phase: PHASE1/PHASE2 → PHASE1

  3. Sep 2024 — Mar 2025 [monthly]

    Completed PHASE1/PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  5. Jun 2024 — Jul 2024 [monthly]

    Completed PHASE1_PHASE2

    Status: Active Not Recruiting → Completed

▶ Show 12 earlier versions

  1. May 2024 — Jun 2024 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  2. Mar 2024 — May 2024 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Status: Recruiting → Active Not Recruiting

  3. Dec 2023 — Mar 2024 [monthly]

    Recruiting PHASE1_PHASE2

  4. Nov 2023 — Dec 2023 [monthly]

    Recruiting PHASE1_PHASE2

  5. Sep 2023 — Nov 2023 [monthly]

    Recruiting PHASE1_PHASE2

  6. Jul 2023 — Sep 2023 [monthly]

    Recruiting PHASE1_PHASE2

  7. May 2023 — Jul 2023 [monthly]

    Recruiting PHASE1_PHASE2

  8. Feb 2023 — May 2023 [monthly]

    Recruiting PHASE1_PHASE2

  9. Nov 2022 — Feb 2023 [monthly]

    Recruiting PHASE1_PHASE2

  10. Sep 2022 — Nov 2022 [monthly]

    Recruiting PHASE1_PHASE2

  11. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Not Yet Recruiting → Recruiting

  12. Jun 2022 — Jul 2022 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Tvardi Therapeutics, Incorporated
Data source: Tvardi Therapeutics, Incorporated

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

Study Locations