# A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer

Source: https://onco.cc/trials/nct07349069/  
OnCo record `nct07349069` (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 Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer is a phase 3 interventional study registered as NCT07349069, led by Shandong Suncadia Medicine, and recruiting on the registry. Official title: A Randomised, Open-Label, Phase III Trial to Compare HRS-8080 Versus Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer Who Have Received at Least 2 Years of Standard Adjuvant Endocrine Therapy. Planned enrolment is 5500 participants (estimated). The study started in 2026-03-04 and primary completion is expected in 2030-12. No results have been posted on ClinicalTrials.gov.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-11
- Tags: ctgov-ingest
- Registry id: NCT07349069
- Phase: 3
- Setting: A Randomized, Open-Label, Phase III Trial to Compare HRS-8080 Versus Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer Who Have Received at Least 2 Years of Standard Adjuvant Endocrine Therapy
- Sponsor: Shandong Suncadia Medicine
- Enrolled: 5500

## Sources

- ClinicalTrials.gov NCT07349069: https://clinicaltrials.gov/study/NCT07349069

## Connected records

- cancers: [High-risk early HR-positive breast cancer](https://onco.cc/cancers/hr-positive-early-high-risk/), [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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