Actively Recruiting
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.
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2026-03-27
912
Participants Needed
1
Research Sites
299 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 75 years
- Eastern Cooperative Oncology Group performance status of 0 to 1
- Histologically confirmed locally advanced or metastatic breast cancer
- Prior adjuvant endocrine resistance after curative-intent surgery
- Postmenopausal, perimenopausal, or premenopausal status
- Presence of evaluable lesions
- Adequate organ function as required
You will not qualify if you...
- Rapidly progressing disease unsuitable for endocrine therapy
- Previous treatment with fulvestrant or novel SERMs (except tamoxifen and toremifene)
- Uncontrolled brain metastases, carcinomatous meningitis, or spinal cord compression
- History of clinically significant cardiovascular disease
- Not recovered from adverse effects of prior therapies
- History of another malignancy within 5 years or currently having another malignancy
- Known allergy to HRS-8080, fulvestrant, dalpiciclib, or their components
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital Fifth Medical Center
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
Z
Zhan Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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