RecruitingPhase 2NCT06656624

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


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

190 participants

Start Date

Aug 13, 2024

Study Type

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

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study (RACHEL) is testing whether ribociclib (a targeted oral cancer pill) combined with an aromatase inhibitor (a hormone-blocking drug) works better than chemotherapy followed by hormone therapy in women with a specific type of advanced breast cancer: estrogen-receptor positive (but only weakly, 10–50% expression), HER2-negative. **You may be eligible if...** - You are a woman 18 or older with advanced or metastatic breast cancer - Your tumor is estrogen-receptor positive (ER expression 10–50%) and HER2-negative - You are in reasonable overall health (ECOG 0–2) - Your cancer has been confirmed by tissue biopsy **You may NOT be eligible if...** - Your breast cancer has very high ER expression (above 50%) or is HER2-positive - You have already received multiple lines of treatment for advanced disease - You have serious organ problems or another active cancer - You are male 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

DRUGRibociclib combined with AI±OFS

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.

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

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)

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

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NCT06656624


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