NCT07354022RecruitingPhase 3
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.
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.
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 912 (estimated)
- First submitted
- 8 Jan 2026
- Start date
- May 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07354022
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 912
- From May 2026 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have previously received fulvestrant or other novel SERMs (excluding tamoxifen and toremifene);
- Participants who have not recovered from adverse effects caused by prior therapies;
Other illness
- Patients with rapidly progressing disease, as judged by the investigator to be unsuitable for endocrine therapy;
- Patients with a history of clinically significant cardiovascular disease;
- 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.
Other
- Patients with uncontrolled brain metastases, carcinomatous meningitis, or spinal cord compression;
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese PLA General Hospital Fifth Medical Center Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.