Efficacy and Safety of Ribociclib Combined With AI Versus Physician&Amp;#39;s Choice of Chemotherapy Sequential Endocrine Therapy in ER Middle-low-expression/HER2-negative Advanced Breast Cancer (Rachel)

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT06656624
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Ribociclib combined with AI±OFS — DRUG
    Ribociclib: 600mg /d, 3 weeks continuous oral withdrawal for 1 week; AI: Anastrozole 1mg, 1 time /d, oral; Letrozole: 2.5mg, 1 time /d, oral; Exemestane Tablets: 25mg, 1 time /d, oral Goserelin: 3.6 mg every 28 days, subcutaneous injection in the abdomen.
  • physician's choice of chemotherapy sequential Ribociclib combined with AI±OFS — DRUG
    Docetaxel: 100mg/m2 IV drip every 21 days; Paclitaxel: 175mg/m2 every 21 days, IV drip; Paclitaxel for Injection (Albumin Bound): 100\~150mg/m2 IV drip every 7 days; 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; AI: Anastrozole 1mg, 1 time /d, oral; Letrozole: 2.5mg, 1 time /d, oral; Exemestane Tablets: 25mg, 1 time /d, oral Goserelin: 3.6 mg every 28 days, subcutaneous injection in the abdomen.

Study Details

To compare the efficacy and safety of ribociclib in combination with aromatase inhibitor and physician's choice of chemotherapy sequential endocrine therapy in the first-line treatment of ER medium to low expression/HER2-negative advanced breast cancer.

Key Dates

Start date
Aug 13, 2024
Status verified
Oct 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

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

Arms

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

Related Studies