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

StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Enrollment increased: 4800 → 5500 participantsv4 Show 4 more changesShow less
    • Interventions: HRS-8080 Tablets (Drug), Letrozole tablets (Drug), Tamoxifen Citrate Tablets (Drug) to Anastrozole Tablets (Drug), Exemestane tablets (Drug), HRS-8080 Tablets (Drug), Letrozole tablets (Drug), Tamoxifen Citrate Tablets (Drug)
    • Secondary endpoints: details revised at 2 of 3 entries
    • Eligibility criteria shortened, about 5 words
    • Study title expanded, about 3 words
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2026 to Mar 4, 2026
    • Site details revised at 2 of 2 sites
    v3
  3. Study title shortened, about 1 wordv2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The study is being conducted to evaluate the efficacy and safety of HRS-8080 in patients with intermediate or high risk early breast cancer.
Trial Details
NCT Number NCT07349069
Lead Sponsor Shandong Suncadia Medicine Co., Ltd.
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 5,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov