deltatrials
Active Not Recruiting PHASE3 INTERVENTIONAL 2-arm NCT04158362

Endocrine Therapy With Abemaciclib or Chemotherapy as Initial Metastatic Treatment in ER+/HER2- Breast Cancer (AMBRE)

Open-label, Randomized, Multicenter, Phase III Study, Comparing Standard Chemotherapy to Standard Combination of Endocrine Therapy With Abemaciclib as Initial Metastatic Treatment Among Patients With Visceral Metastasis of ER+ HER2-breast Cancer, High Burden Disease

Sponsor: UNICANCER

Updated 13 times since 2019 Last updated: Sep 17, 2025 Started: Jun 11, 2020 Primary completion: Apr 30, 2025 Completion: Jun 30, 2028
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04158362, this PHASE3 trial focuses on Cancer Metastatic and remains ongoing. Sponsored by UNICANCER, it has been updated 13 times since 2020, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~May 2020 · 4 months · monthly snapshot~May 2020 – ~Jul 2020 · 2 months · monthly snapshot~Jul 2020 – ~Jan 2021 · 6 months · monthly snapshot~Jan 2021 – ~Apr 2021 · 3 months · monthly snapshot~Apr 2021 – ~Jun 2022 · 14 months · monthly snapshot~Jun 2022 – ~Feb 2024 · 20 months · monthly snapshot~Feb 2024 – ~Jul 2024 · 5 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Sep 2025 · 11 months · monthly snapshot~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshot~Oct 2025 – present · 11 months · monthly snapshot

Change History

13 versions recorded
  1. Oct 2025 — Present [monthly]

    Active Not Recruiting PHASE3

  2. Sep 2025 — Oct 2025 [monthly]

    Active Not Recruiting PHASE3

  3. Oct 2024 — Sep 2025 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  4. Sep 2024 — Oct 2024 [monthly]

    Recruiting PHASE3

  5. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE3

Show 8 earlier versions
  1. Feb 2024 — Jul 2024 [monthly]

    Recruiting PHASE3

  2. Jun 2022 — Feb 2024 [monthly]

    Recruiting PHASE3

  3. Apr 2021 — Jun 2022 [monthly]

    Recruiting PHASE3

  4. Jan 2021 — Apr 2021 [monthly]

    Recruiting PHASE3

  5. Jul 2020 — Jan 2021 [monthly]

    Recruiting PHASE3

    Status: SuspendedRecruiting

  6. May 2020 — Jul 2020 [monthly]

    Suspended PHASE3

    Status: Not Yet RecruitingSuspended

  7. Jan 2020 — May 2020 [monthly]

    Not Yet Recruiting PHASE3

  8. Dec 2019 — Jan 2020 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • UNICANCER
Data source: UNICANCER

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