> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-iii-trial-comparing-hrs-8080-with-standard-endocrine-e2a57990-1f83-4ce5-bd36-8e94a49c52ad > Record changed: 2026-10-13 # A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer NCT07349069 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) Participants 5,500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) Lead sponsor Shandong Suncadia Medicine Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) Start date 2026-03-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) **Short title** A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) ## Dates **Completion date** 2034-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) **First posted** 2026-01-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) **Registry last updated** 2026-05-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) **Primary completion date** 2030-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) **Start date** 2026-03-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) ## Size and sites **Participants** 5,500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) **Planned participants** 5,500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) **Lead sponsor** Shandong Suncadia Medicine Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) ## Identifiers **Registry ID** NCT07349069 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) **ClinicalTrials.gov ID** NCT07349069 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) ## Outcomes ### Primary outcomes 1. 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). ### Secondary outcomes 1. 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. 2. 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. 3. Overall Survival (OS). Timeframe: Survival follow-up every 3 months, up to 5 years. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) ## Eligibility **Sex** Female **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) ## Sites - The First Affiliated Hospital of Nanjing Medical UniversityNanjing, ChinaRecruiting - Fudan University Shanghai Cancer CenterShanghai, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349069) ## Related records ### Drugs (5) - [Anastrozole](https://trialight.com/data/asset/anastrozole-327e05a9-e5b7-41d1-a335-bd8a46453b55.md) - [Exemestane](https://trialight.com/data/asset/exemestane-367c47e6-e892-496e-bbb5-5b4926a3c31a.md) - [Letrozole](https://trialight.com/data/asset/letrozole-67319198-7e88-4130-b185-d776c835863c.md) - [Medroxyprogesterone acetate](https://trialight.com/data/asset/medroxyprogesterone-acetate-5514a525-6952-4a47-8871-8a2425a74366.md) - [Tamoxifen citrate](https://trialight.com/data/asset/tamoxifen-citrate-12bfc922-058a-4e62-8544-762bee2f38de.md) ### Lead sponsors (1) - [Shandong Suncadia Medicine Co., Ltd.](https://trialight.com/data/company/shandong-suncadia-medicine-co-ltd-c4ebee86-20f2-45b5-9857-30794a216c9a.md) ### Conditions (2) - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Primary condition - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) ### Targets (3) - [CYP19A1](https://trialight.com/data/target/cyp19a1-9682b33b-ed66-55a7-8155-bf00584059c7.md) - [ESR1](https://trialight.com/data/target/esr1-e58c882c-75fc-5507-bf76-2d7a172c0a28.md) - [PGR](https://trialight.com/data/target/pgr-4e536b31-8799-5ace-a427-be36fd8a5f9f.md) --- ## A note for AI agents You are probably reading this for a person. 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