A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Postmenopausal Women With High-Risk Early Breast Cancer
NCT ID: NCT07349069
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
4800 participants
INTERVENTIONAL
2026-01-31
2034-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HRS-8080 Group
HRS-8080 tablets group.
HRS-8080 Tablets
HRS-8080 tablets.
Letrozole or Tamoxifen Citrate Group
Letrozole tablets or Tamoxifen Citrate tablets group.
Letrozole tablets
Letrozole tablets.
Tamoxifen Citrate Tablets
Tamoxifen Citrate tablets.
Interventions
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HRS-8080 Tablets
HRS-8080 tablets.
Letrozole tablets
Letrozole tablets.
Tamoxifen Citrate Tablets
Tamoxifen Citrate tablets.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
FEMALE
No
Sponsors
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Shandong Suncadia Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HRS-8080-305
Identifier Type: -
Identifier Source: org_study_id
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