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ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer

Study acronym: ABBY
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment reduced: 66 → 44 participants Eligibility criteria expanded, about 56 wordsv13 Show 1 more changeShow less
    • Eligibility criteria expanded, about 56 words

    See this version in full on ClinicalTrials.gov ↗

  2. 2 versions Re-verified since Apr 2, 2025, no change to tracked fieldsv11-v12
  3. Site contact updatedv10
  4. Re-verified, no change to tracked fieldsv9
  5. Eligibility criteria expanded, about 131 wordsv8 See this version in full on ClinicalTrials.gov ↗
Show 6 earlier versionsHide 6 earlier versions
  1. Eligibility criteria expanded, about 205 wordsv7 See this version in full on ClinicalTrials.gov ↗
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Oct 18, 2021 to Nov 1, 2021 · Site details revisedv6 Show 2 more changesShow less
    • Start date changed from estimate of Oct 18, 2021 to Nov 1, 2021
    • Site details revised
  3. Start date: Aug 2021 to Oct 18, 2021 Study title revisedv5 Show 1 more changeShow less
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  4. Start date: Apr 2021 to Aug 2021v4
  5. Start date: Dec 2020 to Apr 2021 Primary completion date: Aug 2027 to Dec 2027 · Completion date: Aug 2028 to Dec 2028v3 Show 2 more changesShow less
    • Primary completion date: Aug 2027 to Dec 2027
    • Completion date: Aug 2028 to Dec 2028
  6. Start date: Aug 2020 to Dec 2020v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a Phase II randomized, controlled, open label breast cancer clinical trial. 66 patients will be enrolled. The drugs being studied are hydroxychloroquine (Plaquenil) and abemaciclib (also Verzenio). This research study is testing whether using these drugs to target the disseminated tumor cells in bone marrow can reduce their number or eliminate them. Both hydroxychloroquine and abemaciclib are pills that will be taken twice daily. Both are approved by the FDA
Trial Details
NCT Number NCT04523857
Lead Sponsor Abramson Cancer Center at Penn Medicine
Conditions Breast Cancer
Enrollment 44 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov