clinical trial · NCT07354022
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.
Shandong Suncadia Medicine Co., Ltd.·phase3·recruiting·n = 912
Locally Advanced or Metastatic Breast CancerHRS-8080 Tablet ; Dalpiciclib IsethionateFulvestrant injection ;Dalpiciclib Isethionate
brief summary
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.
started
Mar 4, 2026
primary completion
Dec 1, 2028
completion
Dec 1, 2031
last updated
Mar 27, 2026
official title
A Multicenter, Open-label, Randomized Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of HRS-8080 Combined With Dalpiciclib Versus Fulvestrant Combined With Dalpiciclib in Patients With Locally Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol