HRS-8080 versus standard endocrine pills for women with high-risk early breast cancer

A Randomized, Open-Label, Phase III Trial to Compare HRS-8080 Versus Standard Endocrine Therapy in Patients With High-Risk Early Breast Cancer Who Have Received at Least 2 Years of Standard Adjuvant Endocrine Therapy

This trial tests whether taking HRS-8080 works better than standard endocrine pills (letrozole or tamoxifen) for women with high-risk early breast cancer who have finished 2–5 years of prior endocrine therapy.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4800 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Shandong Suncadia Medicine Co., Ltd. (Industry-sponsored)
• Locations: 2 sites (Nanjing, Jiangsu and 1 other locations)
• Trial ID: NCT07349069 on ClinicalTrials.gov

What this trial studies

This Phase III interventional trial compares HRS-8080 tablets with standard endocrine therapy (letrozole or tamoxifen) in patients with high-risk stage II–III early breast cancer. Eligible participants are adult women who completed 2–5 years of adjuvant endocrine therapy, have no evidence of recurrence or metastasis, and meet standard performance and lab criteria. Participants will receive either HRS-8080 or a standard endocrine agent and will be followed for safety and measures of cancer control. The study is conducted at academic cancer centers in China and tracks both treatment effects and adverse events over the course of follow-up.

Who should consider this trial

Good fit: Women aged 18–75 with histologically confirmed invasive high-risk early (stage II–III) breast cancer, no recurrence or metastasis, ECOG 0–1, adequate organ function, and who have completed 2–5 years of adjuvant endocrine therapy are typical candidates.

Not a fit: Patients with recurrent or metastatic breast cancer, significant organ dysfunction, active severe toxicities from prior therapy, or those outside the age/eligibility criteria are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, HRS-8080 could lower the chance of recurrence and improve long-term outcomes compared with current standard endocrine pills.

How similar studies have performed: Modifying or extending endocrine therapy has shown benefit in some settings, but HRS-8080 is a novel agent and does not yet have established phase III results in this disease.

Eligibility criteria

Inclusion Criteria:

1. Female patients aged ≥ 18 and ≤ 75 years with clinical stage II-III disease. Premenopausal patients must be willing to receive LHRH agonist therapy during the study period.
2. Histologically confirmed invasive breast cancer by postoperative pathology, having received at least 2 years, but no more than 5 years, of adjuvant endocrine therapy.
3. No evidence of recurrent or metastatic disease after surgery.
4. ECOG performance status of 0 or 1.
5. Adequate organ and bone marrow function.
6. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization and be willing to use acceptable non-hormonal contraception methods from the time of informed consent until 7 months after the last dose of the study drug.
7. Any acute toxicities from previous anti-tumor therapy have resolved to Grade 0-1 (per CTCAE v5.0).
8. The patient has provided written informed consent (ICF), and is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

1. Tumor clinical stage IV (metastatic) breast cancer.
2. History and/or treatment of any malignancy other than breast cancer within 5 years prior to randomization.
3. History of severe pulmonary disease, such as interstitial lung disease.
4. Concurrent or potential use of any anti-tumor therapy not specified in the study protocol.
5. Major surgical procedure within 4 weeks prior to randomization.
6. HIV infection or known AIDS, active hepatitis B, hepatitis C, or co-infection with hepatitis B and C.
7. Poor cardiac function.
8. Severe infection within 4 weeks prior to randomization.
9. History of drug allergy.
10. History of organ transplantation.
11. History of substance abuse.
12. Women within 1 year postpartum or who are currently breastfeeding.
13. Patients deemed by the investigator as unsuitable for participation in this study.

Where this trial is running

Nanjing, Jiangsu and 1 other locations

• The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yue He

Conditions Breast Cancer