NCT05467891

Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer

A Phase II Study of Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Oana Danciu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 combination with ET per physician choice. 2. Physician's Choice Endocrine Therapy: ET consists of one of the following: * 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.

Conditions

• Locoregional Recurrence
• Hormone Receptor-positive Breast Cancer
• HER2-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Ribociclib	400 mg orally once daily Days 1-21 (28 day Cycle)
DRUG	Fulvestrant	500 mg intramuscularly on Day 1 and 15 of Cycle 1 then Day 1 of Cycle 2+
DRUG	Anastrozole	1 mg orally once daily
DRUG	Letrozole	2.5 mg orally once daily
DRUG	Exemestane	25 mg orally once daily

Timeline

• Start date: 2022-09-13
• Primary completion: 2028-08-15
• Completion: 2029-08-15
• First posted: 2022-07-21
• Last updated: 2026-04-08

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study