CDK4/6 Inhibitors in Patients With Hormone Receptor-positive Advanced Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CDK4/6 inhibitor.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Survival Outcomes, Adverse Events and Predictive Biomarkers for CDK4/6 Inhibitors in Patients With Hormone Receptor-positive Advanced Breast Cancer, an Ambispective Single-center Cohort Study
Overview
This is an ambispective, single-center study to evaluate the survival outcomes, adverse events and predictive biomarkers for CDK4/6 inhibitors in patients with hormone receptor-positive advanced breast cancer.
Interventions
- Drug CDK4/6 inhibitor
CDK4/6 inhibitors
Primary outcome measures
- Progression-Free Survival (PFS) [Time frame: From the date of starting CDK4/6 inhibitor to the date of first documentation of progression or death (up to approximately 2.5 years)]
Secondary outcome measures (2)
- Overall survival [Time frame: From the date of starting CDK4/6 inhibitor until death from any cause up to 3 years]
- Adverse events [Time frame: From the date of starting CDK4/6 inhibitor to the end of the treatment (up to approximately 2.5 years)]
Eligibility criteria
Inclusion criteria
- Aged ≥18 and older
- Confirmed diagnosis of hormone receptor-positive breast cancer.
- Subjects with locoregionally recurrent or metastatic disease not amenable to curative therapy.
- Subjects have received or plan to receive CDK4/6 inhibitors for advanced disease.
- ECOG 0-2
- Adequate organ function
Exclusion criteria
- Subjects disable to swallow pills.
- History of immunodeficiency disease
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Renji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai
Identifiers
NCT: NCT05795335 · KY2022-097-B