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

May 18, 2026 updated by: Shandong Suncadia Medicine Co., Ltd.

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

The study is being conducted to evaluate the efficacy and safety of HRS-8080 in patients with intermediate or high risk early breast cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

5500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • The First Affiliated Hospital of Nanjing Medical University
        • Principal Investigator:
          • Qiang Ding
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Principal Investigator:
          • Zhimin Shao
        • Contact:
        • Contact:
        • Principal Investigator:
          • Keda Yu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Female patients aged ≥ 18 and ≤ 75 years. Premenopausal patients must meet the eligibility of LHRH agonist therapy during the study period.
  2. Histologically confirmed invasive breast cancer by postoperative pathology, having received at least 2 years, but no more than 5 years, of adjuvant endocrine therapy.
  3. No evidence of recurrent or metastatic disease after surgery.
  4. ECOG performance status of 0 or 1.
  5. Adequate organ and bone marrow function.
  6. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization and be willing to use acceptable non-hormonal contraception methods from the time of informed consent until 7 months after the last dose of the study drug.
  7. Any acute toxicities from previous anti-tumor therapy have resolved to Grade 0-1 (per CTCAE v5.0).
  8. The patient has provided written informed consent (ICF), and is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

  1. Tumor clinical stage IV (metastatic) breast cancer.
  2. History and/or treatment of any malignancy other than breast cancer within 5 years prior to randomization.
  3. History of severe pulmonary disease, such as interstitial lung disease.
  4. Concurrent or potential use of any anti-tumor therapy not specified in the study protocol.
  5. Major surgical procedure within 4 weeks prior to randomization.
  6. HIV infection or known AIDS, active hepatitis B, hepatitis C, or co-infection with hepatitis B and C.
  7. Poor cardiac function.
  8. Severe infection within 4 weeks prior to randomization.
  9. History of drug allergy.
  10. History of organ transplantation.
  11. History of substance abuse.
  12. Women within 1 year postpartum or who are currently breastfeeding.
  13. Patients deemed by the investigator as unsuitable for participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HRS-8080 Group
HRS-8080 tablets group.
Drug: HRS-8080 Tablets
HRS-8080 tablets.
Active Comparator: Standard endocrine therapy Group
Standard endocrine therapy: Letrozole tablets or Tamoxifen Citrate tablets or Anastrozole tablets or Exemestane tablets.
Drug: Letrozole tablets
Letrozole tablets.
Drug: Tamoxifen Citrate Tablets
Tamoxifen Citrate tablets.
Drug: Anastrozole Tablets
Anastrozole tablets.
Drug: Exemestane tablets
Exemestane tablets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time from the date of randomization to the first occurrence of any of the following events: ipsilateral local or contralateral invasive recurrence, distant recurrence, or death from any cause.
Time Frame: At Week 24, Week 56, Week 80, and Week 104 during the initial 104-week period, and then every 52 weeks thereafter, up to 5 years.
Invasive Breast Cancer-Free Survival (IBCFS).
At Week 24, Week 56, Week 80, and Week 104 during the initial 104-week period, and then every 52 weeks thereafter, up to 5 years.

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS).
Time Frame: Survival follow-up every 3 months, up to 5 years.
Survival follow-up every 3 months, up to 5 years.
Invasive Disease-Free Survival (IDFS).
Time Frame: At Week 24, Week 56, Week 80, and Week 104 during the initial 104-week period, and then every 52 weeks thereafter, up to 5 years.
At Week 24, Week 56, Week 80, and Week 104 during the initial 104-week period, and then every 52 weeks thereafter, up to 5 years.
Distant Metastasis-Free Survival (DRFS).
Time Frame: At Week 24, Week 56, Week 80, and Week 104 during the initial 104-week period, and then every 52 weeks thereafter, up to 5 years.
At Week 24, Week 56, Week 80, and Week 104 during the initial 104-week period, and then every 52 weeks thereafter, up to 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Suncadia Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2026

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

January 1, 2034

Study Registration Dates

First Submitted

January 9, 2026

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Actual)

January 16, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRS-8080-305

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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