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.
Recruiting now · Phase 3
Conditions studied: Locally Advanced or Metastatic Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT07354022
- Run by
- Shandong Suncadia Medicine Co., Ltd.
- People needed
- 912
- Starts
- 2026-05-05
- Expected to finish
- 2031-12-01
- Last updated by the study team
- 2026-06-02
Who can join
Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Women aged 18 - 75 years old;
- Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1;
- Patients with histologically confirmed locally advanced or metastatic breast cancer;
- Patients with prior adjuvant endocrine resistance following curative-intent surgery;
- Menstrual status: postmenopausal, perimenopausal, or premenopausal;
- Presence of evaluable lesions;
- Organ function must meet required criteria.
You may not qualify if…
- Patients with rapidly progressing disease, as judged by the investigator to be unsuitable for endocrine therapy;
- Patients who have previously received fulvestrant or other novel SERMs (excluding tamoxifen and toremifene);
- Patients with uncontrolled brain metastases, carcinomatous meningitis, or spinal cord compression;
- Patients with a history of clinically significant cardiovascular disease;
- Participants who have not recovered from adverse effects caused by prior therapies;
- Participants with a history of another malignancy within the past 5 years or currently having another malignancy;
- Known hypersensitivity to HRS-8080, fulvestrant, dalpiciclib, or any of their components, etc.
Where it is running
- Chinese PLA General Hospital Fifth Medical Center — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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