Breast cancer
Conditions
Interventions
Palbociclib Observation Group (Part 1):None
Dalsillie Observation Group (Part I):None
Abemaciclib Observation Group (Part 1):None
Ribociclib Observation Group (Part 1):None
Part II: Population pharmacokinetic profiling of dalcilib in HR+/HER2 ? breast cancer:None
Sponsors
The Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Part I 1. HR+/HER2- advanced or metastatic breast-cancer patients who are currently receiving or scheduled to receive palbociclib, abemaciclib, dalpiciclib, or ribociclib-based regimens. 2. Completion of at least one full treatment cycle with a CDK4/6 inhibitor regimen. 3. Availability of complete medical records and relevant diagnostic/examination data. Part II 1. HR+/HER2-breast-cancer patients who are currently receiving dalpiciclib. 2. Completion of at least one full treatment cycle with dalpiciclib regimen. 3. Availability of complete medical records and relevant diagnostic/examination data. 4. Patients taking dalpiciclib undergo at least one hematological examination during the follow-up period.
Exclusion criteria
Exclusion criteria: Part I 1. Prior exposure to any CDK4/6 inhibitor or participation in a CDK4/6 inhibitor clinical trial. 2. Absence of efficacy data, e.g., no CT imaging reports. Part II 1. Patients with excessive missing data in demographic statistics and laboratory test results. 2. Patients whose medical record information is incomplete and whose medication was discontinued for an extended period (more than one month).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective remission rate;The proportion of patients who remain progression-free at multiple time intervals (e.g., 3, 6, 12, and 18 months).;Health utility value;Evaluate the population pharmacokinetic characteristics of daseliz in breast cancer patients, as well as the PK/PD characteristics of neutropenia; | — |
Countries
China
Contacts
Public ContactCaifeng Jia
The Fourth Hospital of Hebei Medical University
Outcome results
None listed