Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-31 @ 7:24 PM
Study NCT ID:
NCT06470633
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Efficacy of Adebrelimab Combined With Chemotherapy After HIFU Induction Neoadjuvant Therapy HR+/HER2- Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D015251', 'term': 'Epirubicin'}, {'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 29}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-18', 'studyFirstSubmitDate': '2024-06-18', 'studyFirstSubmitQcDate': '2024-06-18', 'lastUpdatePostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'tpCR', 'timeFrame': '6 months', 'description': 'total pathologic complete response rate（lymph node and breast）'}], 'secondaryOutcomes': [{'measure': 'bpCR', 'timeFrame': '6 months', 'description': 'breast pathologic complete response rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HR+/HER2- early breast cancer', 'HIFU', 'Immunotherapy', 'Neoadjuvant therapy'], 'conditions': ['Breast Cancer', 'HR+/HER2- Breast Cancer']}, 'descriptionModule': {'briefSummary': 'To explore the efficacy and safety of adebrelimab combined with chemotherapy (epirubicin + cyclophosphamide →docetaxel) neoadjuvant therapy early HR+/HER2- breast cancer with high risk factors after the induction treatment of HIFU and adebrelimab.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female patients aged ≥ 18 years who require a negative pregnancy test for premenopausal and perimenopausal patients and promise to take reliable contraceptive measures during treatment;\n2. Histopathologically confirmed breast cancer patients who with hormone receptor- positive, which defined as estrogen receptor (ER) ≥ 1%, and/ or progesterone receptor (PR) ≥ 1%, and HER-2 (0 or +), or ++,but FISH is no amplification;\n3. Tumor size ≥ 3cm, and histological grade is 3 (poorly differentiated);\n4. Regardless of lymph node status, but without distant metastasis;\n5. According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, they have at least one evaluable target lesion;\n6. ECOG PS score: 0 - 1;\n7. New York Heart Association (NYHA) functional class I;\n8. Electrocardiogram without myocardial ischemia, echocardiography LVEF \\> 55%, cardiac markers: cardiac troponin I (cTnI) and brain natriuretic peptide (BNP) test values within the normal range;\n9. Normal major organ function, Meet the following criteria:\n\nWBC ≥ 4.0 × 10 9/L,Neutrophil count (ANC) ≥ 1.5 × 10 9/L; platelet ≥ 100 × 10 9/L; hemoglobin ≥ 10 g/dL; serum creatinine ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) ≤ 2.5 × ULN; alanine aminotransferase (ALT) ≤ 2.5 × ULN; total bilirubin ≤ 1.5 × ULN; serum creatinine ≤ 1.5 × ULN; 9.The subject is able to understand the study procedures, voluntarily join the study, sign the informed consent form, have good compliance, and cooperate with the follow-up.\n\nExclusion Criteria:\n\n1. Patients during pregnancy and lactation, women of childbearing age who refuse to take effective contraceptive measures during the study period; Patients with peripheral nervous system disorders caused by diseases or those with a history of significant mental disorders and central nervous system disorders;\n2. Serious or uncontrolled infections that may affect the evaluation of study treatment or study results, including but not limited to: active hepatitis virus infection, human immunodeficiency virus (HIV) antibody positive, lung infection, etc.;\n3. Known allergy to the active ingredients or other components of the study drug or surgical contraindications;\n4. In addition to cured basal cell carcinoma of the skin and cured cervical carcinoma in situ, other cancers are disease-free for less than 5 years;\n5. Severe liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrolled diabetes, active gastrointestinal ulcers and other need treatment;\n6. Need to receive other anti-tumor therapy (except ovarian function inhibitors) during neoadjuvant therapy as judged by the investigator;\n7. Patients who are participating in other clinical trials within one month;\n8. Patients with severe heart disease or discomfort, Expected intolerance to chemotherapy,Including, but not limited to: a. fatal arrhythmia or higher grade atrioventricular block (second-degree type 2 \\[Mobitz 2\\] atrioventricular block or third-degree atrioventricular block); b. unstable angina pectoris; c. clinically significant valvular heart disease; d. transmural myocardial infarction on electrocardiogram; e. uncontrolled hypertension;\n9. Any other conditions that in the opinion of the investigator would make the patient inappropriate for participation in this study.'}, 'identificationModule': {'nctId': 'NCT06470633', 'briefTitle': 'To Evaluate the Efficacy of Adebrelimab Combined With Chemotherapy After HIFU Induction Neoadjuvant Therapy HR+/HER2- Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'To Evaluate the Efficacy and Safety of Adebrelimab Combined With Chemotherapy Neoadjuvant Therapy in Early or Local Advanced Breast Cancer After Induction Treatment of High-intensity Focused Ultrasound and Adebrelimab', 'orgStudyIdInfo': {'id': 'NJMU- BC03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HIFU+Adebrelimab+Chemotherapy', 'description': 'Induction phase: HIFU+Adebrelimab Neoadjuvant Therapy phase: Adebrelimab+ EC-T(Epirubicin + Cyclophosphamide → Docetaxel', 'interventionNames': ['Drug: Adebrelimab', 'Procedure: High Intensity Focused Ultrasoun（HIFU）', 'Drug: Cyclophosphamide', 'Drug: Epirubicin', 'Drug: Docetaxel']}], 'interventions': [{'name': 'Adebrelimab', 'type': 'DRUG', 'otherNames': ['PD-Li'], 'description': 'Adebrelimab 1200mg iv q3w', 'armGroupLabels': ['HIFU+Adebrelimab+Chemotherapy']}, {'name': 'High Intensity Focused Ultrasoun（HIFU）', 'type': 'PROCEDURE', 'description': 'HIFU treatment at lesion site', 'armGroupLabels': ['HIFU+Adebrelimab+Chemotherapy']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': '600mg/m2 iv q3w', 'armGroupLabels': ['HIFU+Adebrelimab+Chemotherapy']}, {'name': 'Epirubicin', 'type': 'DRUG', 'description': '90mg/m2 iv q3w', 'armGroupLabels': ['HIFU+Adebrelimab+Chemotherapy']}, {'name': 'Docetaxel', 'type': 'DRUG', 'description': '75mg/m2 iv q3w', 'armGroupLabels': ['HIFU+Adebrelimab+Chemotherapy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Wenbin Zhou, Professor', 'role': 'CONTACT', 'email': 'Zhouwenbin@njmu.edu.cn', 'phone': '025-68308162'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jiangsu Hengrui Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Wenbin Zhou', 'investigatorAffiliation': 'The First Affiliated Hospital with Nanjing Medical University'}}}}