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

Sponsor
Fudan University
Study ID
NCT07423611
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 1, 2026
Status verified
Feb 2026
Primary completion
Oct 1, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
388 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm #1: Endocrine+Ribocilcib
    Aromatase inhibitor (± ovarian suppression) plus Ribocilcib without chemotherapy
  • Active Comparator: Arm #2: TC*4→Endocrine+Ribocilcib
    4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy, followed by aromatase inhibitor (± ovarian suppression) plus Ribocilcib

Primary Outcome Measure

ctDNA negativity rate [ Time Frame: 3 years ]

Central Contacts

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