MedTrace Logo

Dalpiciclib Combined With Endocrine Therapy and Metronomic Capecitabine vs Dalpiciclib Combined With Endocrine Therapy for First-line Treatment

NCT07467330 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2026-03-12

No results posted yet for this study

Summary

This study is an open-label, multicenter, randomized controlled study. It is planned to include 258 patients with HR +/HER2- advanced breast cancer with visceral metastases. Eligible subjects will be randomized 1:1 to receive dalpiciclib in combination with endocrine therapy and metronomic capecitabine chemotherapy in the experimental arm and dalpiciclib in combination with endocrine therapy in the control arm. Randomization was stratified by the number of lines of therapy for recurrent metastases (0 versus 1) and endocrine therapy (AI versus fulvestrant).

Conditions

Interventions

DRUG

dalpiciclib + endocrine therapy

Control group received dalpiciclib combined with endocrine therapy

DRUG

dalpiciclib + capecitabine + endocrine therapy

The experimental arm received dalpiciclib combined with endocrine therapy and metronomic capecitabine chemotherapy

Sponsors & Collaborators

  • Fujian Cancer Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-15
Primary Completion
2031-12-31
Completion
2032-12-31

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 NCT07467330 on ClinicalTrials.gov