# 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

Source: https://onco.cc/trials/nct07354022/  
OnCo record `nct07354022` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial testing HRS-8080 in HR-positive / HER2-negative breast cancer, now recruiting.

## Summary

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 is a phase 3 interventional study registered as NCT07354022, led by Shandong Suncadia Medicine, and recruiting on the registry. Official title: A Multicenter, Open-label, Randomised Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of HRS-8080 Combined With Dalpiciclib Versus Fulvestrant Combined With Dalpiciclib in Patients With Locally Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy. Planned enrolment is 912 participants (estimated). The study started in 2026-05-05 and primary completion is expected in 2028-12. No results have been posted on ClinicalTrials.gov.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-11
- Tags: ctgov-ingest
- Registry id: NCT07354022
- Phase: 3
- Setting: A Multicenter, Open-label, Randomized Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of HRS-8080 Combined With Dalpiciclib Versus Fulvestrant Combined With Dalpiciclib in Patients With Locally Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy
- Sponsor: Shandong Suncadia Medicine
- Enrolled: 912

## Sources

- ClinicalTrials.gov NCT07354022: https://clinicaltrials.gov/study/NCT07354022

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- drugs: [HRS-8080](https://onco.cc/drugs/hrs-8080/)
- companies: [Jiangsu Hengrui Pharmaceuticals](https://onco.cc/companies/hengrui/)

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