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Clinical Trials in China / NCT07349069
Recruiting Phase 3

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

NCT07349069 · tracked via the Priya Life Science China tracker
Sponsor
Shandong Suncadia Medicine Co., Ltd.
Phase
Phase 3
Started
2026-03-04
Last updated
2026-05-22

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

HRS-8080 TabletsLetrozole tabletsTamoxifen Citrate TabletsAnastrozole TabletsExemestane tablets

HRS-8080 Tablets: HRS-8080 tablets.

Letrozole tablets: Letrozole tablets.

Tamoxifen Citrate Tablets: Tamoxifen Citrate tablets.

Anastrozole Tablets: Anastrozole tablets.

Exemestane tablets: Exemestane tablets.

Study summary

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

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
The First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu Recruiting
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality Recruiting

More Shandong Suncadia Medicine Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07349069 on ClinicalTrials.gov ↗ ← All trials in China