A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorShandong Suncadia Medicine Co., Ltd.

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

Treatment groups

5,500 Participants
are divided into 2 treatment groups