University of Michigan Rogel Cancer Center
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.
Inclusion Criteria: * ER and/or PR-positive (≥ 1% positivity as determined by local pathology laboratory), HER2-negative breast cancer with \> 3 lymph nodes involved on sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) OR have between 1-3 lymph nodes involved AND have T3 disease OR have between 1-3 lymph nodes involved and grade 3 breast cancer. * Age ≥ 18 * 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 elapse between surgical treatment for breast cancer and initiation…
400 mg daily with a possibly dose reduction to 200 mg daily if required
50 Gy in 25 fractions or 42.56 Gy in 16 fraction +/- 10 Gy boost including comprehensive nodal
Arctuva estimate
Verify or correct the compensation shown for this listing.