Oana Danciu
This is an open label, multicenter, single arm phase II study to evaluate the efficacy and safety of ribociclib and ET in patients with locoregional recurrence of HR-positive, HER2-negative breast cancer.
Collection of Correlative Samples at First Recurrence (Stage I consent) If feasible, optional correlative blood and fresh tissue will be collected during surgical excision of their 1st recurrence. Patients should then complete radiation therapy if that is indicated. Enrollment to the Treatment Phase will occur within 6 months of the last local treatment, surgery or radiation treatment, whichever occurred last. Study Treatment (Stage II/ main consent) Treatment includes: 1. Ribociclib: Oral ribociclib at a dose of 400 mg daily for 21 days out of a 28-day cycle. Ribociclib will be used in…
Eligibility Criteria to Collect Optional Correlative Blood and Tissue at Local Recurrence * Written informed consent (stage I) and HIPAA authorization for release of personal health information obtained prior to performing any study-specific procedures. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. * Male or female age ≥ 18 years at the time of consent. * Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer based on the most recently analyzed tissue sa…
400 mg orally once daily Days 1-21 (28 day Cycle)
500 mg intramuscularly on Day 1 and 15 of Cycle 1 then Day 1 of Cycle 2+
1 mg orally once daily
2.5 mg orally once daily
25 mg orally once daily