A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer
NCT07349069
Phase
Phase 3
Recruitment status
Recruiting
Participants
5,500
Lead sponsor
Shandong Suncadia Medicine Co., Ltd.
Start date
2026-03-04
Number of sites
- 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.
- Short title
- A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer
- Official title
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2034-01-01
- First posted
- 2026-01-16
- Registry last updated
- 2026-05-22
- Primary completion date
- 2030-12-01
- Start date
- 2026-03-04
- Participants
- 5,500
- Participant count basis
- Estimated
- Planned participants
- 5,500
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07349069
- ClinicalTrials.gov ID
- NCT07349069
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Sources for study design
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.
Timeframe: 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).
Invasive Disease-Free Survival (IDFS).
Timeframe: 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).
Timeframe: 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.
Overall Survival (OS).
Timeframe: Survival follow-up every 3 months, up to 5 years.
Sources for outcomes
- Sex
- Female
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- 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.
- 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.
Sources for eligibility
- The First Affiliated Hospital of Nanjing Medical UniversityNanjing, ChinaRecruiting
- Fudan University Shanghai Cancer CenterShanghai, ChinaRecruiting
Sources for sites
Related records
Drugs (5)
Lead sponsors (1)
Conditions (2)
- Breast cancer Primary condition
- Breast neoplasm