Ignite Creation Date:
2025-12-24 @ 12:39 PM
Ignite Modification Date:
2025-12-27 @ 9:57 PM
Study NCT ID:
NCT05692661
Status:
RECRUITING
Last Update Posted:
2023-01-20
First Post:
2023-01-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dose Escalation Study of Proton and Carbon Ion Irradiation for HER2 Positive and Triple Negative Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}, {'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': 'D011522', 'term': 'Protons'}, {'id': 'D063193', 'term': 'Heavy Ion Radiotherapy'}], 'ancestors': [{'id': 'D002414', 'term': 'Cations, Monovalent'}, {'id': 'D002412', 'term': 'Cations'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D006859', 'term': 'Hydrogen'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D000071940', 'term': 'Nucleons'}, {'id': 'D004601', 'term': 'Elementary Particles'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2026-01-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-11', 'studyFirstSubmitDate': '2023-01-11', 'studyFirstSubmitQcDate': '2023-01-11', 'lastUpdatePostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute toxicity', 'timeFrame': '3 months after the completion of CIRT', 'description': 'Treatment related acute toxicity assessed by CTCAE v4.03'}], 'secondaryOutcomes': [{'measure': 'Local regional recurrence', 'timeFrame': 'within 5 years after radiotherapy.', 'description': 'The Ipsilateral breast and regional lymph nodes recurrence'}, {'measure': 'Cosmetic outcome as measured by Breast Cancer Treatment Outcomes Scale', 'timeFrame': 'within 5 years after radiotherapy.', 'description': 'Cosmetic outcome will be evaluated by Breast Cancer Treatment Outcomes Scale filled out by patients.'}, {'measure': 'Cosmetic outcome as measured by BCCT.core software', 'timeFrame': 'within 5 years after radiotherapy.', 'description': "Patients' photographs of the breasts will be taken. With the use of BCCT.core software from The Breast Research group (INESC TEC) cosmetic outcome will be assessed."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'HER2 Positive', 'Triple Negative', 'Proton and Carbon Ion', 'Dose Escalation'], 'conditions': ['Triple Negative Breast Cancer', 'HER2-positive Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Adjuvant radiotherapy is the standard treatment for early breast cancer after breast conserving surgery. Molecular subtypes was significantly associated with the risk of local recurrence of breast cancer. Nguyen et al found that the overall 5-year cumulative incidence of local recurrence was 0.8% for luminal A, 1.5% for luminal B, 8.4% for HER2 positive, and 7.1% for triple negative breast cancer after lumpectomy and radiotherapy. Her2 positive and triple negative breast cancers may be inherently radioresistant.\n\nTherefore, for HER2 positive and triple negative breast cancer with high local recurrence and radiation resistance, proton combined with carbon ion is proposed after breast conserving surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed HER2 positive or Triple Negative invasive breast carcinoma.(HER2 positive: immunohistochemistry \\[IHC\\] 3+ and or fluorescence in situ hybridization \\[FISH\\] amplified; Triple Negative: estrogen receptor \\[ER\\] and progesterone receptor \\[PR\\] \\< 1%, HER2 negative \\[IHC 1+ or 2+ FISH non-amplified\\])\n* Age ≥ 18 years and ≤ 80 years.\n* The primary tumor must be excised via breast conserving surgery.\n* Stage p T1-2 N0 M0\n* ECOG performance status ≤2.\n\nExclusion Criteria:\n\n* Invasive breast cancer not confirmed by pathology.\n* Distant metastasis\n* Prior thoracic radiation.\n* Pregnancy or lactating.'}, 'identificationModule': {'nctId': 'NCT05692661', 'briefTitle': 'A Dose Escalation Study of Proton and Carbon Ion Irradiation for HER2 Positive and Triple Negative Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Proton and Heavy Ion Center'}, 'officialTitle': 'A Dose Escalation Study of Proton and Carbon Ion Irradiation for HER2 Positive and Triple Negative Breast Cancer After Breast Conserving Surgery', 'orgStudyIdInfo': {'id': 'SPHIC-TR-BCa2022-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'proton plus carbon ion radiotherapy', 'description': 'CTV1: whole breast, proton therapy. CTVboost: Tumor bed, carbon ion dose escalation study with four dose levels.', 'interventionNames': ['Radiation: proton plus carbon ion radiotherapy']}], 'interventions': [{'name': 'proton plus carbon ion radiotherapy', 'type': 'RADIATION', 'description': 'CTV1: whole breast, 40.05Gy(RBE) in 15 fractions with proton ion therapy; CTVboost: Tumor bed, carbon ion dose escalation study with four dose levels \\[10.2Gy(RBE)/3Fx,10.8Gy(RBE) /3Fx,11.4Gy(RBE)/3Fx and 12Gy(RBE)/3Fx \\].', 'armGroupLabels': ['proton plus carbon ion radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ping Li', 'role': 'CONTACT', 'email': 'ping.li@sphic.org.cn', 'phone': '+86 021-38296666'}], 'facility': 'Shanghai Proton and Heavy Ion center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Proton and Heavy Ion Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Qing Zhang,MD', 'investigatorAffiliation': 'Shanghai Proton and Heavy Ion Center'}}}}