A Study to Evluate Efficacy and Safety of HRS-8080 Combined With Dalpiciclib in Patients With Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy.

StatusRecruiting
PhasePhase 3
Started

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Record History

  1. Start date: Mar 4, 2026 to May 5, 2026v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 2026 to Mar 4, 2026
    • Site details revised
    v2
  3. 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.
The study is being conducted to evaluate the efficacy and safety of HRS-8080 combined with dalpiciclib versus fulvestrant combined with dalpiciclib in patients with locally advanced/metastatic breast cancer who had developed drug resistance to prior adjuvant endocrine therapy.
Trial Details
NCT Number NCT07354022
Lead Sponsor Shandong Suncadia Medicine Co., Ltd.
Conditions
(from sponsor)		 Locally Advanced or Metastatic Breast Cancer
Related terms Breast Neoplasms
Enrollment 912 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov