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.
Condition(s) studied
Investigational drug(s) / intervention(s)
HRS-8080 Tablet ; Dalpiciclib Isethionate: * HRS-8080 Tablet * Dalpiciclib Isethionate
Fulvestrant injection ;Dalpiciclib Isethionate: * Fulvestrant injection * Dalpiciclib Isethionate
Study 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.
Eligibility
Primary outcome measure(s)
- Investigator assessed Progression free survival (PFS) — Up to 5 years.
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), or death from any cause during the study.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Chinese PLA General Hospital Fifth Medical Center | Beijing | Beijing Municipality | Recruiting |
More Shandong Suncadia Medicine Co., Ltd. trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07354022 on ClinicalTrials.gov ↗ ← All trials in China