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

Recruiting now · Phase 3

Conditions studied: Breast Cancer

In brief

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

Key facts

Study ID

NCT07349069

Run by

Shandong Suncadia Medicine Co., Ltd.

People needed

5500

Starts

2026-03-04

Expected to finish

2034-01-01

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female patients aged ≥ 18 and ≤ 75 years. Premenopausal patients must meet the eligibility of LHRH agonist therapy during the study period.
• Histologically confirmed invasive breast cancer by postoperative pathology, having received at least 2 years, but no more than 5 years, of adjuvant endocrine therapy.
• No evidence of recurrent or metastatic disease after surgery.
• ECOG performance status of 0 or 1.
• Adequate organ and bone marrow function.
• 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.
• Any acute toxicities from previous anti-tumor therapy have resolved to Grade 0-1 (per CTCAE v5.0).
• 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.

You may not qualify if…

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

Where it is running

• The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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