Efficacy and Safety of Ribociclib in Combination With NSAI Versus Physician's Choice of Chemotherapy Sequential Endocrine Therapy in HR+/HER2- Advanced Breast Cancer

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT06375707
Phase
PHASE2
Status
Unknown

Conditions

  • Advanced Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • physician's choice of chemotherapy sequential Ribociclib combined with NSAI±OFS — DRUG
    Docetaxel: 100mg/m2 IV every 21 days Paclitaxel: 175mg/m2 every 21 days, IV drip Vinorelbine: 25mg/ m2 on days 1 and 8 of each cycle, 1 cycle in 21 days, IV drip Capecitabine: 1000mg/m2, 2 times/d, 2 consecutive weeks of oral discontinuation for 1 week. Ribociclib: 600mg /d, 3 weeks continuous oral withdrawal for 1 week NSAI: Anastrozole 1mg, 1 time /d, oral or Letrozole: 2.5mg, 1 time /d, oral
  • Ribociclib combined with NSAI±OFS — DRUG
    Ribociclib: 600mg /d, 3 weeks continuous oral withdrawal for 1 week NSAI: Anastrozole 1mg, 1 time /d, oral or Letrozole: 2.5mg, 1 time /d, oral

Study Details

Evaluate the efficacy and safety of Ribociclib in combination with NSAI versus physician's choice of chemotherapy sequential endocrine therapy in HR+/HER2- advanced breast cancer.

Key Dates

Start date
Jan 9, 2024
Status verified
Apr 2024
Primary completion
Nov 30, 2025
Completion
Dec 31, 2025

Study Design

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

Arms

  • Active Comparator: physician's choice of chemotherapy sequential Ribociclib combined with NSAI±OFS
  • Experimental: Ribociclib combined with NSAI±OFS

Primary Outcome Measure

Progression Free Survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]

Central Contacts

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