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

Shandong Suncadia Medicine

Status and phase: Not yet enrolling; Phase 3

Conditions: Breast Cancer

Treatments: Drug: HRS-8080 Tablets; Drug: Tamoxifen Citrate Tablets; Drug: Letrozole tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT07349069

HRS-8080-305

Details and patient eligibility

About

The study is being conducted to evaluate the efficacy and safety of HRS-8080 in patients with high-risk early breast cancer.

Enrollment: 4,800 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,800 participants in 2 patient groups

HRS-8080 Group

Experimental group

Description:

HRS-8080 tablets group.

Treatment:

Drug: HRS-8080 Tablets

Letrozole or Tamoxifen Citrate Group

Active Comparator group

Description:

Letrozole tablets or Tamoxifen Citrate tablets group.

Treatment:

Drug: Letrozole tablets

Drug: Tamoxifen Citrate Tablets