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Culmerciclib Plus Anlotinib and Endocrine Therapy for HR-Positive/HER2-Negative Metastatic Breast Cancer With Brain Metastases

NCT07745257 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-04

No results posted yet for this study

Summary

This study aims to evaluate the efficacy and safety of adding the anti-angiogenic agent anlotinib to the combination of the CDK2/4/6 inhibitor Culmerciclib and endocrine therapy in patients with HR+/HER2- breast cancer and brain metastases. Eligible patients present with newly diagnosed brain metastases or brain metastases that progressed following prior local therapy. It is hoped that this therapeutic combination can achieve disease control in these patients.

Conditions

  • HR-positive, HER2-negative Metastatic Breast Cancer With Brain Metastases

Interventions

DRUG

Culmerciclib

180 mg orally once daily

DRUG

Anlotinib

12 mg orally once daily on Days 1-14 of every 3-week cycle

DRUG

Endocrine Therapy

administered per approved prescribing information

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Shusen Wang, MD · Sun Yat-sen University CancerCenter

  • Cuizhi Geng, MD · Hebei Medical University Fourth Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2026-08-28
Primary Completion
2027-12-28
Completion
2028-07-28

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT07745257 on ClinicalTrials.gov