Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 10:58 AM
Study NCT ID:
NCT07349069
Status:
RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With High-Risk Early Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077289', 'term': 'Letrozole'}, {'id': 'D013629', 'term': 'Tamoxifen'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4800}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2034-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-01-09', 'studyFirstSubmitQcDate': '2026-01-09', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': 'Every 26 weeks for the first 104 weeks after randomization, and then every 52 weeks thereafter, up to 5 years.', 'description': 'Invasive Breast Cancer-Free Survival (IBCFS).'}], 'secondaryOutcomes': [{'measure': 'Invasive Disease-Free Survival (IDFS).', 'timeFrame': 'Every 26 weeks for the first 104 weeks after randomization, and then every 52 weeks thereafter, up to 5 years.'}, {'measure': 'Distant Metastasis-Free Survival (DRFS).', 'timeFrame': 'Every 26 weeks for the first 104 weeks after randomization, and then every 52 weeks thereafter, up to 5 years.'}, {'measure': 'Overall Survival (OS).', 'timeFrame': 'Survival follow-up every 3 months, up to 5 years.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The study is being conducted to evaluate the efficacy and safety of HRS-8080 in patients with high-risk early breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 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.\n2. Histologically confirmed invasive breast cancer by postoperative pathology, having received at least 2 years, but no more than 5 years, of adjuvant endocrine therapy.\n3. No evidence of recurrent or metastatic disease after surgery.\n4. ECOG performance status of 0 or 1.\n5. Adequate organ and bone marrow function.\n6. 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.\n7. Any acute toxicities from previous anti-tumor therapy have resolved to Grade 0-1 (per CTCAE v5.0).\n8. 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.\n\nExclusion Criteria:\n\n1. Tumor clinical stage IV (metastatic) breast cancer.\n2. History and/or treatment of any malignancy other than breast cancer within 5 years prior to randomization.\n3. History of severe pulmonary disease, such as interstitial lung disease.\n4. Concurrent or potential use of any anti-tumor therapy not specified in the study protocol.\n5. Major surgical procedure within 4 weeks prior to randomization.\n6. HIV infection or known AIDS, active hepatitis B, hepatitis C, or co-infection with hepatitis B and C.\n7. Poor cardiac function.\n8. Severe infection within 4 weeks prior to randomization.\n9. History of drug allergy.\n10. History of organ transplantation.\n11. History of substance abuse.\n12. Women within 1 year postpartum or who are currently breastfeeding.\n13. Patients deemed by the investigator as unsuitable for participation in this study.'}, 'identificationModule': {'nctId': 'NCT07349069', 'briefTitle': 'A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With High-Risk Early Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shandong Suncadia Medicine Co., Ltd.'}, 'officialTitle': 'A Randomized, Open-Label, Phase III Trial to Compare HRS-8080 Versus Standard Endocrine Therapy in Patients With High-Risk Early Breast Cancer Who Have Received at Least 2 Years of Standard Adjuvant Endocrine Therapy', 'orgStudyIdInfo': {'id': 'HRS-8080-305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HRS-8080 Group', 'description': 'HRS-8080 tablets group.', 'interventionNames': ['Drug: HRS-8080 Tablets']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Letrozole or Tamoxifen Citrate Group', 'description': 'Letrozole tablets or Tamoxifen Citrate tablets group.', 'interventionNames': ['Drug: Letrozole tablets', 'Drug: Tamoxifen Citrate Tablets']}], 'interventions': [{'name': 'HRS-8080 Tablets', 'type': 'DRUG', 'description': 'HRS-8080 tablets.', 'armGroupLabels': ['HRS-8080 Group']}, {'name': 'Letrozole tablets', 'type': 'DRUG', 'description': 'Letrozole tablets.', 'armGroupLabels': ['Letrozole or Tamoxifen Citrate Group']}, {'name': 'Tamoxifen Citrate Tablets', 'type': 'DRUG', 'description': 'Tamoxifen Citrate tablets.', 'armGroupLabels': ['Letrozole or Tamoxifen Citrate Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiang Ding', 'role': 'CONTACT', 'email': 'q.ding@hotmail.com', 'phone': '+86-025-68306259'}, {'name': 'Qiang Ding', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhimin Shao', 'role': 'CONTACT', 'email': 'szmgcp2016@163.com', 'phone': '+86-021-64175590'}, {'name': 'Keda Yu', 'role': 'CONTACT', 'email': 'yukeda@163.com', 'phone': '+86-021-64175590'}, {'name': 'Zhimin Shao', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Keda Yu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yue He', 'role': 'CONTACT', 'email': 'yue.he.yh58@hengrui.com', 'phone': '+86-0518-82342973'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong Suncadia Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}