About this trial
The study is being conducted to evaluate the efficacy and safety of HRS-8080 in patients with intermediate or high risk early breast cancer.
Eligibility criteria
Qualifiers
Female patients aged ≥ 18 and ≤ 75 years. Premenopausal patients must meet the eligibility of LHRH agonist therapy during the study period.
Histologically confirmed invasive breast cancer by postoperative pathology, having received at least 2 years, but no more than 5 years, of adjuvant endocrine therapy.
No evidence of recurrent or metastatic disease after surgery.
ECOG performance status of 0 or 1.
Disqualifiers
Tumor clinical stage IV (metastatic) breast cancer.
History and/or treatment of any malignancy other than breast cancer within 5 years prior to randomization.
History of severe pulmonary disease, such as interstitial lung disease.
Concurrent or potential use of any anti-tumor therapy not specified in the study protocol.
Trial design
Treatments tested in this trial
- HRS-8080 Tablets
- Letrozole tablets
- Tamoxifen Citrate Tablets
- Anastrozole Tablets
- Exemestane tablets