Actively Recruiting
A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With High-Risk Early Breast Cancer
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2026-03-19
4800
Participants Needed
2
Research Sites
408 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is being conducted to evaluate the efficacy and safety of HRS-8080 in patients with high-risk early breast cancer.
CONDITIONS
Official Title
A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With High-Risk Early Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 75 years with clinical stage II-III breast cancer
- Premenopausal patients willing to receive LHRH agonist therapy during the study
- Histologically confirmed invasive breast cancer by postoperative pathology
- 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
- Negative serum pregnancy test within 7 days before randomization for women of childbearing potential
- Willing to use acceptable non-hormonal contraception from informed consent until 7 months after last dose
- Acute toxicities from previous anti-tumor therapy resolved to Grade 0-1
- Provided written informed consent and willing to comply with study procedures
You will not qualify if you...
- Tumor clinical stage IV (metastatic) breast cancer
- History 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
- 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 currently breastfeeding
- Patients deemed unsuitable for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
2
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Y
Yue He
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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