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Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Breast Cancer

NCT07410559 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2026-02-18

No results posted yet for this study

Summary

This is a prospective, open-label, single-center, randomized controlled Phase II clinical study aimed at evaluating the efficacy and safety of neoadjuvant imlunestrant combined with abemaciclib guided by the Ki67 index after 2 weeks in patients with ER+/HER2- breast cancer.

Conditions

Interventions

DRUG

Imlunestrant + abemaciclib

Imlunestrant (400 mg orally, once daily) combined with abemaciclib (150 mg orally, twice daily) for 24 weeks.

DRUG

(dd)EC*4-T*4

Epirubicin (90 mg/m², intravenous infusion) combined with cyclophosphamide (600 mg/m², intravenous infusion, every 2 weeks or 3 weeks, determined by investigators) for 4 cycles, followed by docetaxel (100 mg/m², intravenous infusion, every 3 weeks) for 4 cycles.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2029-04-01
Completion
2031-07-01

Countries

  • China

Study Locations

More Related Trials

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 NCT07410559 on ClinicalTrials.gov