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

NCT07446686 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

CDK4/6 inhibitor±endocrine therapy drug±OFS treatment combined with synchronous radiotherapy

After the patient is confirmed to be enrolled, the CDK4/6i dose for the next patient is determined by a dose allocation model (empirical logistic model, obtained using the R dfcrm software package) based on the DLT observed in all previously evaluated patients. The starting dose of CDK4/6i (abexiclib, oral) is 50 mg bid, and other dose levels are: 100 mg bid, 150 mg bid.

Sponsors & Collaborators

  • Guizhou Provincial People's Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07446686 on ClinicalTrials.gov