NCT07423611

ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer

A Multicenter, Open-label, Randomized Controlled Clinical Study Comparing the Efficacy and Safety of ctDNA-guided Ribociclib Plus Endocrine Therapy Versus Chemotherapy Followed by Ribociclib Plus Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 388 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, multicenter, open-label, randomized controlled clinical trial designed to determine whether ribociclib plus endocrine therapy (ET) is non-inferior to adjuvant chemotherapy followed by ribociclib plus ET in patients with circulating tumor DNA (ctDNA)-negative, hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer.

Detailed description

This study is a prospective, multicenter, open-label, randomized controlled clinical trial designed to determine whether ribociclib plus endocrine therapy (ET) is non-inferior to adjuvant chemotherapy followed by ribociclib plus ET in patients with circulating tumor DNA (ctDNA)-negative, hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer. Patients with HR+/HER2- early breast cancer who have undergone definitive surgery will be enrolled and must undergo ctDNA-MRD analysis within 4 weeks after surgery. Patients who are ctDNA negative will be randomly assigned (1:1) to two study groups, according to stratification factors: menopausal status (premenopausal vs. postmenopausal). The experimental group will receive ribociclib plus aromatase inhibitor (AI) or ovarian function suppression (OFS), while the control group will receive chemotherapy followed by ribociclib plus AI or OFS. The safety and efficacy of each group will be assessed through ctDNA nagative rate, invasive disease free survival (iDFS), and adverse effects (AE) as graded by Common Terminology Criteria for Adverse Events (CTCAE) 5.0 and patient reported outcome (PRO).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Aromatase inhibitor (± ovarian suppression) plus Ribociclib	Aromatase inhibitor (± ovarian suppression) plus Ribociclib
DRUG	4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy	4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy

Timeline

• Start date: 2026-10-01
• Primary completion: 2030-10-01
• Completion: 2030-12-31
• First posted: 2026-02-20
• Last updated: 2026-02-20

Locations

1 site across 1 country: China