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Exploring the Impact of body mass index on the efficacy and safety of CDK4/6 inhibitors combined with endocrine therapy in advanced breast cancer.
Body mass index (BMI) is strongly associated with the development and progression of breast cancer. Despite the widespread use of cyclin-dependent kinase (CDK) 4/6 inhibitors combined with endocrine therapy (ET) in hormone receptor (HR)-positive advanced breast cancer, the effect of BMI on therapeutic outcomes remains poorly understood. Here, we present real-world evidence to substantiate the association between BMI and CDK4/6 inhibitors efficacy and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | BMI < 25.0 kg/m² |
| |
| Group 2 | BMI ≥ 25.0 kg/m² |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Impact of BMI on CDK4/6 Inhibitors Efficacy and Safety | Drug | Patients aged ≥18 years with advanced HR-positive breast cancer who received CDK4/6 inhibitors at six hospitals in China were included in this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD. | 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 |
|---|---|---|
| Overall Survival (OS) | It is defined as the time from the start of treatment to death for any reason. | It is defined as the time from the start of treatment to death for any reason, whichever came first, assessed up to 100 months |
| Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients aged ≥18 years with advanced HR-positive breast cancer who received CDK4/6 inhibitors at six hospitals in China were included in this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial People's Hospital | Nanjing | Jiangsu | China |
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| ID | Term |
|---|---|
| D012449 | Safety |
| ID | Term |
|---|---|
| D000056 | Accident Prevention |
| D000059 | Accidents |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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The overall response rate is defined as the percentage of patients with a best overall response of CR or PR relative to the appropriate analysis set |
| From date of observation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| The Number of Participants Who Experienced Adverse Events | Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events). | From date of observation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |