HRS-8080 plus dalpiciclib versus fulvestrant plus dalpiciclib for advanced or metastatic breast cancer after adjuvant endocrine therapy resistance
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.
Run by Shandong Suncadia Medicine Co., Ltd. · NCT07354022 · Data updated 2026-11-12
This trial tests whether adding the new drug HRS-8080 to dalpiciclib works better than fulvestrant with dalpiciclib for people with advanced or metastatic breast cancer that became resistant to prior adjuvant hormonal therapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | Women only |
| Enrollment | 912 (estimated) |
| Sponsor | Shandong Suncadia Medicine Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | May 5, 2026 |
| Main results expected | December 2028 |
| Study ends | December 2031 |
| Registry record updated | June 2, 2026 |
| Trial ID | NCT07354022 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–75 with histologically confirmed locally advanced or metastatic breast cancer who developed resistance to prior adjuvant endocrine therapy, have ECOG 0–1, measurable lesions, and adequate organ function are the intended participants.
✕Probably not a fit
Patients with rapidly progressive disease unsuitable for endocrine therapy, prior fulvestrant or novel SERM exposure, uncontrolled brain metastases, significant cardiovascular disease, or poor recovery from prior treatment are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3 randomized trial compares the combination of HRS-8080 and dalpiciclib against fulvestrant combined with dalpiciclib in patients with locally advanced or metastatic breast cancer who developed resistance to prior adjuvant endocrine therapy. Eligible participants are women aged 18–75 with ECOG performance status 0–1, measurable disease, and adequate organ function. Participants will receive the assigned combination therapies and undergo regular tumor assessments and safety monitoring to measure outcomes such as progression-free survival, response rates, and adverse events. The trial is sponsored by Shandong Suncadia Medicine and is being conducted at the Chinese PLA General Hospital Fifth Medical Center in Beijing.
Why it matters
Potential benefit: If successful, the HRS-8080 combination could extend disease control or delay progression compared with the current fulvestrant-based regimen.
How similar studies have gone: CDK4/6 inhibitors combined with endocrine agents have previously shown benefit in similar settings, but HRS-8080 is a novel agent and its added value is still unproven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Women aged 18 - 75 years old; 2. Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1; 3. Patients with histologically confirmed locally advanced or metastatic breast cancer; 4. Patients with prior adjuvant endocrine resistance following curative-intent surgery; 5. Menstrual status: postmenopausal, perimenopausal, or premenopausal; 6. Presence of evaluable lesions; 7. Organ function must meet required criteria. Exclusion Criteria: 1. Patients with rapidly progressing disease, as judged by the investigator to be unsuitable for endocrine therapy; 2. Patients who have previously received fulvestrant or other novel SERMs (excluding tamoxifen and toremifene); 3. Patients with uncontrolled brain metastases, carcinomatous meningitis, or spinal cord compression; 4. Patients with a history of clinically significant cardiovascular disease; 5. Participants who have not recovered from adverse effects caused by prior therapies; 6. Participants with a history of another malignancy within the past 5 years or currently having another malignancy; 7. Known hypersensitivity to HRS-8080, fulvestrant, dalpiciclib, or any of their components, etc.
Where it's running
-
Chinese PLA General Hospital Fifth Medical Center
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Zhan Zhang
- Email: Zhan.zhang@hengrui.com
- Phone: +86 17721286165
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.