HRS-8080 plus dalpiciclib versus fulvestrant plus dalpiciclib for advanced or metastatic breast cancer after adjuvant endocrine therapy resistance

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.

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
• Enrollment: 912 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Shandong Suncadia Medicine Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07354022 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Beijing, Beijing Municipality

• Chinese PLA General Hospital Fifth Medical Center — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Zhan Zhang

Conditions Locally Advanced or Metastatic Breast Cancer