A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer

StatusRecruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Primary completion moved at least 7 months later Dec 2026 → Aug 2027
See other at-risk trials from Shandong Suncadia Medicine Co., Ltd.

Record History

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  1. Primary completion pushed from Dec 2026 to Aug 2027
    • Eligibility criteria expanded, about 885 words
  2. Primary endpoint revisedv3 Show 4 more changesShow less
    • Enrollment target: 200 to 240
    • Interventions: Everolimus Tablets (Drug), Exemestane tablets (Drug), Fulvestrant injection (Drug), HRS-8080 Tablet (Drug) to Anastrozole Tablets (Drug), Everolimus Tablets (Drug), Exemestane tablets (Drug), Fulvestrant injection (Drug), HRS-8080 Tablet (Drug)…
    • Secondary endpoints revised (7)
    • Study arms: 3 to 4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 2025 to Jul 23, 2025
    • Site details revised at 2 of 2 sites
    v2
  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.
This study is a multicenter, open-label, randomized controlled Phase 3 clinical trial. It is planned to enroll 240 female patients with locally advanced or metastatic breast cancer followed by disease progression after previous endocrine therapy.
Trial Details
NCT Number NCT07024173
Lead Sponsor Shandong Suncadia Medicine Co., Ltd.
Conditions
(from sponsor)		 Locally Advanced Breast Cancer, Metastatic Breast Cancer
Related terms Breast Neoplasms
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov