Impact of BMI on CDK4/6 Inhibitors Efficacy and Safety in Advanced Breast Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

Impact of BMI on CDK4/6 Inhibitors Efficacy and Safety: 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.

Study summary

Exploring the Impact of body mass index on the efficacy and safety of CDK4/6 inhibitors combined with endocrine therapy in advanced breast cancer.

Eligibility

Primary outcome measure(s)

• Progression Free Survival — 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 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.

Trial sites (1)

More The First Affiliated Hospital with Nanjing Medical University trials in China

Other trials for the same condition