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

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 ID
NCT05996107
Phase
PHASE1
Sponsor
University of Michigan Rogel Cancer Center
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Ribociclib
  • Postoperative Radiation Therapy
Locations (sample)
  • Ann Arbor, Michigan, United States|42.27756,-83.74088
  • Wyoming, Michigan, United States|42.91336,-85.70531
  • Cleveland, Ohio, United States|41.4995,-81.69541

Key Eligibility Criteria

  • ER and/or PR-positive (≥ 1% positivity as determined by local pathology laboratory), HER2-negative breast cancer with \> 3 lymph nodes involved on …
  • Patients must have undergone gross total excision of all locoregional disease with negative margins (i.e. no tumor on ink). At least 21 days must e…
  • Patients must have completed chemotherapy (either in neoadjuvant or adjuvant setting). If received adjuvant chemotherapy, chemotherapy must have co…
  • Participants must have recovered (grade ≤1) from the acute effects of chemotherapy and surgical side effects following definitive breast surgery ex…

For full eligibility, visit ClinicalTrials.gov.

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