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Multigene Risk Score Combined With Ki-67 Dynamic Assessment in Stratified Neoadjuvant Endocrine Therapy Treatment With or Without CDK4/6 Inhibitors in HR+/HER2- Breast Cancer

NCT06650748 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-17

No results posted yet for this study

Summary

This is a prospective, single-center, randomize-controlled study. The purpose of this study is to evaluate the efficacy of neoadjuvant CDK4/6 inhibitors in patients with high-risk EPclin multigene risk analysis and non-response to Ki-67 2W, and to explore predictive biomarkers for sensitivity to CDK4/6 inhibitor therapy.

Conditions

Interventions

DRUG

Dalpiciclib

Dalpiciclib, oral administration, 125g each time, once daily, days 1-21, with a 28-day cycle (3 weeks on/1 week off). Continuous medication for 6 cycles, or disease progression, intolerable toxicity, withdrawal from the study for any reason or death, whichever occurs first; or after researcher's judgement, patient would no longer benefit from the treatment.

DRUG

Letrozole

2.5 mg, oral, once daily (continuously), with a 28-day cycle. Continuous medication for 6 cycles, or disease progression, intolerable toxicity, withdrawal from the study for any reason or death, whichever occurs first. Refer to drug instructions for specific usage

Sponsors & Collaborators

  • Peking University

    lead OTHER

Principal Investigators

  • Zhaoqing Fan · Peking University Cancer Hospital & Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2027-10-01
Completion
2028-04-01

Countries

  • China

Study Locations

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Entities

Drugs
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 NCT06650748 on ClinicalTrials.gov