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A Study to Evluate Efficacy and Safety of HRS-8080 Combined With Dalpiciclib in Patients With Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy.

NCT07354022 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 912

Last updated 2026-03-27

No results posted yet for this study

Summary

The study is being conducted to evaluate the efficacy and safety of HRS-8080 combined with dalpiciclib versus fulvestrant combined with dalpiciclib in patients with locally advanced/metastatic breast cancer who had developed drug resistance to prior adjuvant endocrine therapy.

Conditions

Interventions

DRUG

HRS-8080 Tablet ; Dalpiciclib Isethionate

* HRS-8080 Tablet * Dalpiciclib Isethionate

DRUG

Fulvestrant injection ;Dalpiciclib Isethionate

* Fulvestrant injection * Dalpiciclib Isethionate

Sponsors & Collaborators

  • Shandong Suncadia Medicine Co., Ltd.

    lead INDUSTRY

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
2026-03-04
Primary Completion
2028-12-31
Completion
2031-12-31

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 NCT07354022 on ClinicalTrials.gov