Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04158362 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: AMBRE
StatusActive, Not Recruiting
PhasePhase 3
SponsorUNICANCER
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion date: Jun 2028 to Jun 2032v10
  2. Primary completion date changed from estimate of Jun 2025 to Apr 30, 2025v9
  3. Trial status: Recruiting to Active, Not Recruiting Primary completion date: Dec 2024 to Jun 2025 · Site details revised at 2 of 2 sitesv8 Show 2 more changesShow less
    • Primary completion date: Dec 2024 to Jun 2025
    • Site details revised at 2 of 2 sites
  4. Enrollment target: 378 to 180 Primary endpoint revised · Secondary endpoints: 12 to 13 · Study description shortened, about 3 wordsv7 Show 3 more changesShow less
    • Primary endpoint revised
    • Secondary endpoints: 12 to 13
    • Study description shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date: Dec 2022 to Dec 2024 Completion date: Jun 2026 to Jun 2028 · Eligibility criteria shortened, about 23 wordsv6 Show 2 more changesShow less
    • Completion date: Jun 2026 to Jun 2028
    • Eligibility criteria shortened, about 23 words

    See this version in full on ClinicalTrials.gov ↗

Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: Jun 2022 to Dec 2022 Site details revised at 1 of 2 sites · Eligibility criteria expanded, about 1 wordv5 Show 2 more changesShow less
    • Site details revised at 1 of 2 sites
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Suspended to Recruiting Start date changed from estimate of May 2020 to Jun 11, 2020 · Site details revised at 2 of 2 sitesv4 Show 2 more changesShow less
    • Start date changed from estimate of May 2020 to Jun 11, 2020
    • Site details revised at 2 of 2 sites
  3. Trial status: Not Yet Recruiting to Suspended Sponsor's reason: Temporary suspension since March 13 due to COVID-19 pandemic Start date: Jan 2020 to May 2020 · Study sites: 0 to 2v3 Show 2 more changesShow less
    • Start date: Jan 2020 to May 2020
    • Study sites: 0 to 2
  4. Eligibility criteria expanded, about 12 wordsv2 See this version in full on ClinicalTrials.gov ↗
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
UNICANCER
98 trials monitored
See 7 trials at risk
AMBRE is a phase III study comparing two standard treatments as initial metastatic treatment in ER+/HER2- breast cancer (BC) patients with visceral metastasis and high burden disease: Chemotherapy and combination of endocrine therapy with abemaciclib.
Trial Details
NCT Number NCT04158362
Lead Sponsor UNICANCER
Conditions Cancer Metastatic
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov