Breast Cancer
Conditions
Brief summary
The study is being conducted to evaluate the efficacy and safety of HRS-8080 in patients with high-risk early breast cancer.
Interventions
DRUGHRS-8080 Tablets
HRS-8080 tablets.
Letrozole tablets.
DRUGTamoxifen Citrate Tablets
Tamoxifen Citrate tablets.
Sponsors
Shandong Suncadia Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The time from the date of randomization to the first occurrence of any of the following events: ipsilateral local or contralateral invasive recurrence, distant recurrence, or death from any cause. | Every 26 weeks for the first 104 weeks after randomization, and then every 52 weeks thereafter, up to 5 years. | Invasive Breast Cancer-Free Survival (IBCFS). |
Secondary
| Measure | Time frame |
|---|---|
| Invasive Disease-Free Survival (IDFS). | Every 26 weeks for the first 104 weeks after randomization, and then every 52 weeks thereafter, up to 5 years. |
| Distant Metastasis-Free Survival (DRFS). | Every 26 weeks for the first 104 weeks after randomization, and then every 52 weeks thereafter, up to 5 years. |
| Overall Survival (OS). | Survival follow-up every 3 months, up to 5 years. |
Countries
China
Contacts
CONTACTYue He
Outcome results
None listed