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Study of Ribociclib Administered Concurrently With Postoperative Radiation Therapy in Patients With High-Risk, HR+/HER2- Breast Cancer

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Oct 2026 → Feb 2027
See other at-risk trials from University of Michigan Rogel Cancer Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing Show 6 more changesShow less
    • Primary completion pushed from Oct 2026 to Feb 2027
    • Study completion moved earlier from Oct 2030 to Feb 2030
    • Enrollment target: estimated 30 to confirmed 32
    • Eligibility criteria expanded, about 47 words
    • Secondary endpoints: details revised at 3 of 5 entries
    • Site details revised at 3 of 3 sites
  2. Primary completion pushed from Jun 2026 to Oct 2026
    • Study completion pushed from Jun 2030 to Oct 2030
    v12
  3. Study title shortened, about 2 wordsv11
  4. Site contacts updated at 2 of 3 sitesv10
  5. Re-verified, no change to tracked fieldsv9
Show 7 earlier versionsHide 7 earlier versions
  1. Trial status: Suspended to Recruiting
    • Primary completion date: Mar 2026 to Jun 2026
    • Study completion date: Mar 1, 2030 to Jun 2030
    • Site details revised at 3 of 3 sites
    v8
  2. Trial status: Recruiting to Suspended Sponsor's reason: the study is being put on an immediate FDA hold
    • Site details revised at 3 of 3 sites
    v7
  3. Study sites: 1 to 3v6
  4. Start date changed from estimate of Mar 2024 to Feb 27, 2024v5
  5. Start date: Jan 2024 to Mar 2024
    • Primary completion date: Jan 2026 to Mar 2026
    • Study completion date: Jan 1, 2030 to Mar 1, 2030
    v4
  6. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  7. Start date: Oct 2023 to Jan 2024
    • Primary completion date: Oct 2025 to Jan 2026
    • Study completion date: Oct 1, 2029 to Jan 1, 2030
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this research study is to determine the safety, tolerability and dose of Ribociclib when combined with adjuvant radiation in women with high-risk ER+ breast cancer. Once enrolled on study, patients will begin treatment with Ribociclib 400 mg daily at the same time as they initiate standard of care adjuvant radiation therapy- 50 Gy in 25 fractions or 42.56 Gy in 16 fractions +/- 10 Gy boost including comprehensive nodal. Paitents will continue treatment with Ribociclib for up to 6 weeks.
Trial Details
NCT Number NCT05996107
Lead Sponsor University of Michigan Rogel Cancer Center
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov