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.
The main goal of this clinical trial is to compare in the efficacy of Ribociclib in combination with AI versus physician's choice of chemotherapy sequential endocrine therapy in ER medium to low expression/HER2-negative advanced breast cancer and evaluate the PCR DFS,OS and safety of the subjects. The main question it aims is comparing the efficacy and safety of first-line application of CDK4/6 inhibitors combined with initial endocrine therapy versus sequential endocrine therapy after chemotherapy induction therapy in ER medium to low expression/HER2- negative advanced breast cancer. This study is planned to include 190 patients with ER medium to low expression/HER2- negative advanced breast cancer between August 2024 and December 2025 who meet the entry criteria In this study, it is proposed to randomise the enrolled patients using stratified grouping + block randomisation method. The enrolled patients were firstly stratified based on (1) presence of visceral metastases and (2) disease-free interval ≤or ≥ 2 years assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
190
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.
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
RECRUITINGProgression Free Survival
Progression-free survival is defined as the time from the date of randomization to the date of the first documented progression as per local review and according to RECIST 1.1 or death due to any cause.the date of the first documented progression as per local review and according to RECIST 1.1 or death due to any cause.
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
Progression Free Survival2
Refers to the time from randomization to disease progression or death after a patient enters a clinical trial and receives second-line therapy.
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
Time to treatment failure
Time to treatment failure is defined as the time from the date of randomization/start of treatment to the earliest of date of progression, date of death due to any cause, change to other anti-cancer therapy, or date of discontinuation due to reasons other than 'Protocol violation' or 'Administrative problems'.
Time frame: From randomization to treatment failure or withdrawal from the trial; reasons for withdrawal can be patient request, disease progression, death, or adverse events, whichever came first, assessed up to 100 months
Overall response rate
Overall response rate (ORR) is defined as the proportion of patients whose best overall response is either complete response (CR) or partial response (PR), as per local review and according to RECIST 1.1.
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
Overall survival(OS)
Overall survival is defined as the time from the date of randomization to the date of death due to any cause.
Time frame: From date of randomization until the date of death from any cause, assessed up to 100 months
Time To Response
Time to response is defined as the time from the date of randomization to the first documented response of either CR or PR, which must be subsequently confirmed, as defined by RECIST 1.1.
Time frame: From the date of randomization to the first documented response of either CR or PR, whichever came first, assessed up to 100 months
Clinical benefit rate
Clinical benefit rate is defined as the proportion of patients with a best overall response of CR, or PR or stable disease, lasting for a duration of at least 24 weeks, as defined by RECIST 1.1.
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
Frequency/severity of adverse events
Safety of ribociclib in combination with AI and OFS, and combination chemotherapies
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
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