NCT07349069RecruitingPhase 3
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
Shandong Suncadia Medicine Co., Ltd.2 sites in 1 country5,500 target enrollmentStarted: March 4, 2026Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 5,500
- Locations
- 2
- Primary Endpoint
- 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.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Letrozole or Tamoxifen Citrate Group
Active Comparator
Letrozole tablets or Tamoxifen Citrate tablets group.
Intervention: Letrozole tablets (Drug)
HRS-8080 Group
Experimental
HRS-8080 tablets group.
Intervention: HRS-8080 Tablets (Drug)
Outcomes
Primary Outcomes
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.
Time Frame: Every 26 weeks for the first 104 weeks after randomization, and then every 52 weeks thereafter, up to 5 years.
Invasive Breast Cancer-Free Survival (IBCFS).
Secondary Outcomes
- Invasive Disease-Free Survival (IDFS).(Every 26 weeks for the first 104 weeks after randomization, and then every 52 weeks thereafter, up to 5 years.)
- Distant Metastasis-Free Survival (DRFS).(Every 26 weeks for the first 104 weeks after randomization, and then every 52 weeks thereafter, up to 5 years.)
- Overall Survival (OS).(Survival follow-up every 3 months, up to 5 years.)
Investigators
Study Sites (2)
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