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)
Efficacy and Safety of Ribociclib Combined With AI Versus Physician&Amp;#39;s Choice of Chemotherapy Sequential Endocrine Therapy in ER Medium to Low Expression/HER2-negative Advanced Breast Cancer: a Phase II Randomised Controlled Clinical Study
The First Affiliated Hospital with Nanjing Medical University
190 participants
Aug 13, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
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Interventions
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.
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.
Locations(1)
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NCT06656624