Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-26 @ 4:03 PM
Study NCT ID:
NCT06964906
Status:
RECRUITING
Last Update Posted:
2025-05-11
First Post:
2025-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of High-Intensity Focused Ultrasound (HIFU) Combined With Toripalimab Plus Chemotherapy Versus Chemotherapy as Neoadjuvant Therapy for Estrogen Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (NeoHunter)
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': 'C000656314', 'term': 'toripalimab'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}, {'id': 'D015251', 'term': 'Epirubicin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}], 'ancestors': [{'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': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-07', 'studyFirstSubmitDate': '2025-04-28', 'studyFirstSubmitQcDate': '2025-05-07', 'lastUpdatePostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Pathological Complete Response (tpCR) Rate: ypT0/Tis, ypN0', 'timeFrame': 'Up to approximately 30 weeks', 'description': 'The tpCR rate is defined as the proportion of participants with no residual invasive cancer cells in both the breast primary tumor site (residual in situ cancer cells are permitted) and all sampled axillary lymph nodes.'}], 'secondaryOutcomes': [{'measure': 'Breast Pathological Complete Response (bpCR) Rate: ypT0/Tis', 'timeFrame': 'Up to approximately 30 weeks', 'description': 'The bpCR rate is defined as the proportion of participants with no residual invasive cancer cells in the breast primary tumor site (residual in situ cancer cells are permitted).'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to approximately 30 weeks', 'description': 'ORR is defined as the proportion of participants with a complete or partial response.'}, {'measure': 'Event-Free Survival (EFS)', 'timeFrame': 'Approximately five years', 'description': 'EFS is defined as the time from randomization to any of the following events: precludes surgery, local or distant recurrence, second primary malignancy, or death due to any cause.'}, {'measure': 'Adverse Event (AE)', 'timeFrame': 'Approximately three years', 'description': 'An AE is defined as any untoward medical occurrence in a study participant administered a medicinal product, temporally associated with study intervention, without presumption of causality.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Neoplasms', 'High-intensity focused ultrasound', 'PD1', 'Toripalimab', 'nab-Paclitaxel', 'Epirubicin', 'Cyclophosphamide'], 'conditions': ['ER+/HER2- Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of high-intensity focused ultrasound (HIFU) combined with toripalimab plus chemotherapy versus chemotherapy as neoadjuvant therapy for ER+/HER2- breast cancer.', 'detailedDescription': 'Study participants will be randomly allocated to either the experimental group or the control group and receive the following treatments. Experimental group: HIFU therapy followed by 8 cycles of neoadjuvant immunotherapy and chemotherapy; Control group: 8 cycles of neoadjuvant chemotherapy alone. Each cycle lasts 21 days. Subsequently, all participants will undergo surgery within 6 weeks after completion of neoadjuvant therapy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female patients aged 18-75 years.\n2. Invasive breast cancer without distant metastasis, including either T1c-T2 (≥ 2 cm), cN1-cN2, or T3-T4, cN0-cN2.\n3. Histopathologically confirmed ER-positive/HER2-negative, PR \\< 20% or Ki67 ≥ 20%, Grade 3 breast cancer.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n\nExclusion Criteria:\n\n1. Female patients during pregnancy or lactation.\n2. Diagnosis of bilateral breast cancer, occult breast cancer, or distant metastasis confirmed by pathology.\n3. Has an active autoimmune disease that has received systemic treatment in the last 2 years.\n4. Has a known history of human immunodeficiency virus (HIV), hepatitis B, or known active hepatitis C virus infection.\n5. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.\n6. Has a known history of invasive malignancy that required systemic treatment in the last 5 years.\n7. Uncontrolled concomitant diseases include severe infection, liver disease, cardiovascular disease, kidney disease, respiratory disease, diabetes, and others requiring systemic treatment.'}, 'identificationModule': {'nctId': 'NCT06964906', 'acronym': 'NeoHunter', 'briefTitle': 'Study of High-Intensity Focused Ultrasound (HIFU) Combined With Toripalimab Plus Chemotherapy Versus Chemotherapy as Neoadjuvant Therapy for Estrogen Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (NeoHunter)', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'A Randomized, Open-Label, Blinded Endpoint Study of High-Intensity Focused Ultrasound (HIFU) Combined With Toripalimab Plus Chemotherapy Versus Chemotherapy as Neoadjuvant Therapy for Estrogen Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (NeoHunter)', 'orgStudyIdInfo': {'id': '2024-0367'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HIFU/Toripalimab + nab-P/Toripalimab + EC', 'description': 'Participants receive HIFU treatment, followed by toripalimab (Q3W) + nab-Paclitaxel (QW) for 4 cycles (12 weeks), followed by toripalimab (Q3W) + epirubicin (Q3W) + cyclophosphamide (Q3W) for 4 cycles (12 weeks). Each cycle lasts 21 days.', 'interventionNames': ['Procedure: HIFU', 'Drug: Toripalimab', 'Drug: nab-Paclitaxel (nab-P)', 'Drug: Epirubicin (E)', 'Drug: Cyclophosphamide (C)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'nab-P/EC', 'description': 'Participants receive nab-Paclitaxel (QW) for 4 cycles (12 weeks), followed by epirubicin (Q3W) + cyclophosphamide (Q3W) for 4 cycles (12 weeks). Each cycle lasts 21 days.', 'interventionNames': ['Drug: nab-Paclitaxel (nab-P)', 'Drug: Epirubicin (E)', 'Drug: Cyclophosphamide (C)']}], 'interventions': [{'name': 'HIFU', 'type': 'PROCEDURE', 'description': 'HIFU therapy is administered to the targeted breast lesion site.', 'armGroupLabels': ['HIFU/Toripalimab + nab-P/Toripalimab + EC']}, {'name': 'Toripalimab', 'type': 'DRUG', 'description': '240 mg, IV infusion, Q3W', 'armGroupLabels': ['HIFU/Toripalimab + nab-P/Toripalimab + EC']}, {'name': 'nab-Paclitaxel (nab-P)', 'type': 'DRUG', 'description': '125 mg/m2, IV infusion, QW', 'armGroupLabels': ['HIFU/Toripalimab + nab-P/Toripalimab + EC', 'nab-P/EC']}, {'name': 'Epirubicin (E)', 'type': 'DRUG', 'description': '90 mg/m2, IV infusion, Q3W', 'armGroupLabels': ['HIFU/Toripalimab + nab-P/Toripalimab + EC', 'nab-P/EC']}, {'name': 'Cyclophosphamide (C)', 'type': 'DRUG', 'description': '600 mg/m2, IV infusion, Q3W', 'armGroupLabels': ['HIFU/Toripalimab + nab-P/Toripalimab + EC', 'nab-P/EC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yiding Chen', 'role': 'CONTACT', 'email': 'ydchen@zju.edu.cn', 'phone': '+86 0571 87783759'}], 'facility': '2nd Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Yiding Chen', 'role': 'CONTACT', 'email': 'ydchen@zju.edu.cn', 'phone': '+86 0571 87783759'}, {'name': 'Shijie Wu', 'role': 'CONTACT', 'email': 'shijiewu@zju.edu.cn'}], 'overallOfficials': [{'name': 'Yiding Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '2nd Affiliated Hospital, School of Medicine, Zhejiang University, China'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}