HRS-8080 versus doctor‑chosen treatments for locally advanced or metastatic breast cancer

A Multicenter, Open-label, Randomized Controlled Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer With Disease Progression After Previous Endocrine Therapy

This trial will test whether the oral drug HRS-8080 works better than treatments chosen by doctors for women with locally advanced or metastatic breast cancer whose disease progressed after prior endocrine therapy.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Shandong Suncadia Medicine Co., Ltd. (Industry-sponsored)
• Locations: 2 sites (Guangzhou, Guangdong and 1 other locations)
• Trial ID: NCT07024173 on ClinicalTrials.gov

What this trial studies

This is a multicenter, open‑label, randomized Phase 3 trial planned to enroll about 240 women with locally advanced or metastatic breast cancer after progression on 1–2 lines of endocrine therapy. Participants are randomized to receive oral HRS-8080 or physician‑chosen therapy such as fulvestrant, exemestane, everolimus combinations, or anastrozole. Eligible patients are 18–75 years old with ECOG 0–1 and adequate organ function, and the trial will compare clinical outcomes and safety between the groups. Study sites include major cancer centers in China and patients will be followed per protocol treatment and visit schedules.

Who should consider this trial

Good fit: Women aged 18–75 with histologically confirmed locally advanced or metastatic breast cancer who progressed after 1–2 lines of endocrine therapy, have ECOG 0–1, and adequate organ function are the ideal candidates.

Not a fit: Patients with rapidly progressive disease unsuitable for endocrine approaches, severe cardiovascular disease, uncontrolled infection, or uncontrollable tumor‑related pain are unlikely to benefit from this endocrine‑focused comparison.

Why it matters

Potential benefit: If successful, HRS-8080 could provide an additional oral treatment option that improves disease control or tolerability for women whose cancer progressed after endocrine therapy.

How similar studies have performed: Previous trials using fulvestrant, aromatase inhibitors, and everolimus have shown benefit in endocrine‑resistant hormone receptor‑positive disease, while HRS-8080 is an investigational agent being tested in this context.

Eligibility criteria

Inclusion Criteria:

1. Women aged 18 to 75 years old (including both values).
2. ECOG Physical Strength Status (PS) : 0 to 1 point.
3. Patients with locally advanced or metastatic breast cancer confirmed by histology.
4. Patients previously received 1-2 lines of endocrine therapy.
5. Expected survival \> 6 months.
6. The functional level of the organs must meet the requirements.
7. Subjects that voluntarily participate in this clinical trial, be willing and able to abide by the procedures related to clinical visits and research, understand the research procedures and have signed the informed consent.

Exclusion Criteria:

1. Patients with rapid disease progress and investigators determine that endocrine therapy is not suitable or tolerant.
2. A history of severe clinical cardiovascular diseases.
3. Patients with uncontrollable tumor-related pain as judged by investigators.
4. Severe infection exists within 4 weeks before the first study administration.
5. Patients with clinically significant endometrial abnormalities.
6. Untreated active hepatitis.
7. Patients known to be allergic to HRS-8080 components.
8. Pregnant and lactating women, or those planning to become pregnant during the study period.

Where this trial is running

Guangzhou, Guangdong and 1 other locations

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)

Study contacts

• Study coordinator: Min Li

Conditions Locally Advanced Breast Cancer; Metastatic Breast Cancer