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| Name | Class |
|---|---|
| Zhejiang Cancer Hospital | OTHER |
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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.
The main goal of this clinical trial is to compare in the efficacy of Ribociclib in combination with NSAI versus physician's choice of chemotherapy sequential endocrine therapy in HR+/HER2- 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 HR+/HER2-advanced breast cancer with rapidly progressive disease.
This study is planned to include 144 patients with HR+/HER2-advanced breast cancer with rapidly progressive disease between November 2023 and November 2025 who meet the entry criteria. A central dynamic randomisation system was used for 1:1 allocation to the repositories combined with NSAI treatment group and the physician's choice of chemotherapy sequential repositories combined with NSAI treatment group, with stratification factors including: level of HR expression, and presence of liver/lung metastases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| physician's choice of chemotherapy sequential Ribociclib combined with NSAI±OFS | Active Comparator |
| |
| Ribociclib combined with NSAI±OFS | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| physician's choice of chemotherapy sequential Ribociclib combined with NSAI±OFS | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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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Inclusion Criteria:
Patient is an adult female ≥ 18 years old at the time of informed consent.
ECGO rating 0-2.
Histologically confirmed recurrent or metastatic breast cancer, including patients initially diagnosed as stage IV or locally advanced inoperable patients.
Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory. ER should be more than 10% ER positive by local laboratory testing.
Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1 + or 2 + If IHC is 2 +, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing and based on the most recently analyzed tissue sample.
Determination by the physician that the patient is in a rapid disease progression situation:
Patient hasn't received systemic anti-cancer therapy at the stage of recurrence/metastasis.
Patient must have at least one measurable lesion (according to RECIST 1.1 criteria)
Postmenopausal or pre/perimenopausal female patients are eligible for enrolment; pre or perimenopausal female patients must be willing to receive LHRHa during the study period.
All patients were required to meet the following laboratory biochemical values prior to enrolment:
Exclusion Criteria:
Patient is an adult female ≥ 18 years old at the time of informed consent.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongmei Yin, Ph.D | Contact | 025-68307102 | ymyin@njmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial People's Hospital | Recruiting | Nanjing | Jiangsu | 210000 | China |
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| Ribociclib combined with NSAI±OFS | Drug | 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 |
|
| 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'. |
| 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 (ORR) | 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. | 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. | From date of randomization until the date of death from any cause, assessed up to 100 months |
| Time To Response (TTR) | 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. | 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(CBR) | 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. | 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 |
| Change from baseline in the global health status/QOL scale score by using FACT-B questionnaire | Functional Assessment of Cancer Therapy - Breast (FACT-B) will be collected to assess health-related QoL, health status, functioning, disease symptoms, side effects, and cancer-related pain. Descriptive statistics will be used to summarize the overall score at each scheduled assessment time point. Additionally, change from baseline at the time of each assessment will be summarized. The distribution of time to definitive 10% deterioration in the global health status from FACT-B questionnaire will be assessed in the two treatment arms. Scores range from 0 to 4. no subscale. 0 score is the worst for social/family and functional wellbeing and 4 is the worst for physical, emotional wellbeing and additional concerns. | 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, lab abnormalities | Safety of ribociclib in combination with NSAI and OFS, and combination chemotherapies | 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 |