drugset / Trial / NCT07446686

Study on the Safety and Tolerability of Postoperative Radiotherapy Concurrent With CDK4/6 Inhibitors in HR+/HER2- High-Risk Breast Cancer

NCT07446686 ↗

Phase 0 Not yet recruiting 30 enrolled Guizhou Provincial People's Hospital
NaSingle-groupOpen-labelTreatment

Summary

The investigators combined postoperative radiotherapy with CDK4/6 inhibitors ± endocrine adjuvant therapy to explore the tolerability and safety of this treatment regimen in HR+/HER2- postoperative high-risk breast cancer patients. During the study, investigators also utilized PRO scales (FACT-B, FACT-ES, FACT-F) to evaluate patients' multidimensional experiences, such as physical function, emotional state, and treatment-related symptoms, thereby obtaining more authentic and reliable data for symptom assessment and patient benefit.

Timeline

Start
2026-04-01
Primary completion
2027-04-30
Completion
2027-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject abexiclib Unknown 50 mg Oral
Subject abexiclib Unknown 100 mg Oral
Subject abexiclib Unknown 150 mg Oral

Indications