A Phase II Study of Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer
Oana Danciu
Summary
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.
Description
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugRibociclib
400 mg orally once daily Days 1-21 (28 day Cycle)
- DrugFulvestrant
500 mg intramuscularly on Day 1 and 15 of Cycle 1 then Day 1 of Cycle 2+
- DrugAnastrozole
1 mg orally once daily
- DrugLetrozole
2.5 mg orally once daily
- DrugExemestane
25 mg orally once daily
Locations (20)
- University of Alabama at BirminghamBirmingham, Alabama
- University of ArizonaPhoenix, Arizona
- Orlando Health Cancer InstituteOrlando, Florida
- University of Illinois Cancer CenterChicago, Illinois
- Parkview Research CenterFort Wayne, Indiana
- University of Iowa Hospitals and ClinicsIowa City, Iowa