Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-28 @ 5:12 PM
Study NCT ID:
NCT05911958
Status:
RECRUITING
Last Update Posted:
2024-11-04
First Post:
2023-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2029-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-31', 'studyFirstSubmitDate': '2023-06-12', 'studyFirstSubmitQcDate': '2023-06-12', 'lastUpdatePostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR) Tumours (RECIST) v1.1', 'timeFrame': 'During 24 weeks of the neoadjuvant treatment', 'description': 'Objective Response Rate (ORR) according to Response Evaluation Criteria in Solid'}], 'secondaryOutcomes': [{'measure': 'Incidence of Adverse Events', 'timeFrame': 'from consent to 28 days after last dose', 'description': 'Evaluate the nature, incidence and severity of SHR-A1811 adverse events according to CTCAE 5.0'}, {'measure': 'Residual cancer burden (RCB)', 'timeFrame': 'At the time of surgery', 'description': 'Residual cancer burden (RCB)'}, {'measure': 'Pathological complete response', 'timeFrame': 'At the time of surgery', 'description': 'pCR: ypT0/is ypN0'}, {'measure': 'Event-free survival (EFS)', 'timeFrame': '5 years', 'description': 'EFS was defined as the time from randomization to any of the following events: disease progression during neoadjuvant therapy, local or distant recurrence, second primary malignancy (breast or other cancer), or death from any cause'}, {'measure': 'Disease-free survival (DFS)', 'timeFrame': '5 years', 'description': 'Disease-free Survival, From the date of surgery to the first local, regional, contralateral or distant recurrence, and death from any cause'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HER2 Low Breast Carcinoma']}, 'descriptionModule': {'briefSummary': 'HR-positive breast cancers accounts for about 50% to 60% of all breast cancer patients. Neoadjuvant Chemotherapy is the core treatment mode for this type of breast cancer, and endocrine therapy can be used in some low-risk patients. However, the pathological complete response (pCR) rate obtained is low. HER2 is an important prognostic indicator and therapeutic target for breast cancer. Nearly 60% of HR-positive breast cancers have low expression of HER2, and antibody-drug conjugates (ADC) targeting HER2 may achieve better efficacy in this subtype.', 'detailedDescription': 'This prospective, single-arm study is being conducted to evaluate the efficacy and safety of SHR-A1811 for early-stage or locally advanced breast cancer patients with HR-Positive, Low HER2 Expression. Subjects will receive the neoadjuvant therapy of SHR-A1811 for eight cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. The follow-up visit will last for at least 5 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged 18 to 70 years old (inclusive);\n2. Treatment-naive patients with clinically confirmed T2-T3, any nodal status and M0;\n3. HR-positive, HER2 low expression, the expression of Ki-67 exceed 14% invasive breast cancer confirmed by histology or cytology;\n4. ECOG performance status of 0-1;\n5. Normal organ and bone marrow function;\n6. Patients of childbearing age must consent to use highly effective contraception for 7 months from the start of study screening until the last study medication and agree not to breastfeeding;\n7. Patients voluntarily joined the study and signed informed consent;\n\nExclusion Criteria:\n\n1. Patients have evidence of metastatic breast cancer, or inflammatory breast cancer;\n2. Patients previously received antineoplastic therapy or radiotherapy for any malignancy, excluding cured malignancies such as cervical carcinoma in situ, basal cell carcinoma, or squamous carcinoma;\n3. Patients received any other anti-tumor therapy at the same time, including endocrine therapy, bisphosphonates or immunotherapy;\n4. Patients have major surgical procedures unrelated to breast cancer within 4 weeks before the first medication, or not fully recovered from surgical procedures;\n5. Clinically significant pulmonary or cardiovascular disease;\n6. Failure to swallow, chronic diarrhea, intestinal obstruction, or presence of other factors affecting drug administration and absorption;\n7. Known to be allergic to any study drug or any of its excipients;\n8. History of immunodeficiency, including HIV-positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation;\n9. Pregnant and lactating women;\n10. Patients with serious concomitant diseases or other comorbidities that will interfere with the planned treatment, or any other condition that is not suitable for participation assessed by investigator.'}, 'identificationModule': {'nctId': 'NCT05911958', 'briefTitle': 'A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Henan Cancer Hospital'}, 'officialTitle': 'Phase II Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer', 'orgStudyIdInfo': {'id': 'HELEN-015'}, 'secondaryIdInfos': [{'id': 'BC-NEO-IIT-SHR-A1811', 'type': 'OTHER', 'domain': 'Jiangsu Hengrui Medicine Co.,Ltd.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-A1811', 'description': 'SHR-A1811 group', 'interventionNames': ['Drug: SHR-A1811 for injection']}], 'interventions': [{'name': 'SHR-A1811 for injection', 'type': 'DRUG', 'otherNames': ['SHR-A1811 group'], 'description': 'SHR-A1811 for injection', 'armGroupLabels': ['SHR-A1811']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450008', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiao DeChuang', 'role': 'CONTACT', 'email': 'jiaodechuang1982@163.com', 'phone': '13598004327'}], 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Zhenzhen Liu, Professor', 'role': 'CONTACT', 'email': 'liuzhenzhen73@126.com', 'phone': '+86-13603862755'}, {'name': 'Jiujun Zhu, PhD', 'role': 'CONTACT', 'email': 'bigapple0601@126.com', 'phone': '+86-13676962766'}], 'overallOfficials': [{'name': 'Zhenzhen Liu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henan Cancer Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhenzhen Liu', 'investigatorAffiliation': 'Henan Cancer Hospital'}}}}