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.
HER2 Negative Breast Cancer
HCRN-BRE20-468 - A Phase II Study of Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer (RaPhLRR Study)
Breast cancer
All genders
18+
Recruiting now
Overview
Principal Investigator: Rachel Buchsbaum, MD
Contact Us
Latoya Lashley
Study details
Inclusion Criteria
- 1. 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 sample and all tested by local laboratory.
- 2. Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing and based on the most recently analyzed tissue sample.
- 3. Patient has locoregional recurrence of breast cancer: locoregional recurrence is defined as invasive recurrence in the ipsilateral breast, axilla, regional nodes, and chest wall.
Exclusion Criteria
- 1. Patient with a known hypersensitivity to any of the excipients of ribociclib.
- 2. Patient who has received prior CDK4/6 inhibitor for recurrent disease. Patients who
received a CDK4/6 inhibitor in the adjuvant setting may participate if they have been off
therapy for at least 1 year prior to diagnosis of recurrent disease. - 3. Patient has had major surgery within 14 days prior to starting study drug or has not
recovered from major side effects.
Study Requirements
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: Ribociclib (Oral ribociclib at a dose of 600 mg daily for 21 days out of a 28-day cycle. Ribociclib will be used in combination with ET per physician choice.) Physician's Choice Endocrine Therapy (consists of: Intramuscular fulvestrant; Oral anastrozole; Oral letrozole; Oral exemestane; Concomitant use with tamoxifen is not allowed). Ribociclib administration is planned for 36 months and ET administration is planned for 60 months.