RecruitingPhase 2NCT06375707

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

Efficacy and Safety of Ribociclib in Combination With NSAI Versus Physician's Choice of Chemotherapy Sequential Endocrine Therapy in HR+/HER2- Advanced Breast Cancer: a Phase II Randomised Controlled Clinical Trial


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

144 participants

Start Date

Jan 9, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatment approaches for women with hormone receptor-positive, HER2-negative advanced breast cancer: a combination of ribociclib (a targeted oral drug) plus a hormone-blocking drug versus chemotherapy followed by hormone therapy. **You may be eligible if...** - You are a woman aged 18 or older - You have breast cancer that has come back or spread (metastatic) - Your breast cancer tests positive for estrogen or progesterone receptors, and negative for HER2 - Your general health is good enough to tolerate treatment (ECOG score 0–2) **You may NOT be eligible if...** - You have HER2-positive breast cancer - Your breast cancer is hormone receptor-negative - You have severe health conditions that would make treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGphysician's choice of chemotherapy sequential Ribociclib combined with NSAI±OFS

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

DRUGRibociclib combined with NSAI±OFS

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


Locations(1)

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

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NCT06375707


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