Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2025-12-27 @ 4:09 PM
Study NCT ID:
NCT06791161
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-02-14
First Post:
2025-01-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter Prospective Cohort Study of Adjuvant Therapy for BRCA1/2 Mutated Hormone Receptor-positive HER2-negative Early High-risk Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2035-01-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-13', 'studyFirstSubmitDate': '2025-01-17', 'studyFirstSubmitQcDate': '2025-01-23', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Invasive Disease-Free Survival rate', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Distant relapse-free survival rate', 'timeFrame': '3 years'}, {'measure': 'Overall survival rate', 'timeFrame': '3 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['BRCA1/2 mutation'], 'conditions': ['Breast']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of different adjuvant treatment options after surgery for early high-risk breast cancer with BRCA1/2 mutation HR+/HER2'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'BRCA gene mutation HR+/HER2- Early high-risk breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ECOG score 0-1\n* ER\\>10%, PR\\>10%, HER2(0)/HER2(1+)/HER2(2+) and no amplification of FISH\n* BRCA1/2 gene mutation\n* No other site metastases were detected by imaging evaluation after surgical treatment\n* Non-PCR breast cancer after neoadjuvant therapy, or breast cancer with postoperative pathology indicating ≥pN2\n* The patient had no major organ dysfunction\n\nExclusion Criteria:\n\n* Allergic to the investigational drug, inability to take the drug orally, or refusal of the medication regimen\n* Has been enrolled in another study or has been discontinued for less than or equal to 4 weeks\n* There is serious dysfunction of vital organs (heart, liver, kidney)\n* Patients with other malignancies, except cured non-melanoma skin cancer, cervical carcinoma in situ and other tumors that have been cured for at least 5 years\n* In other acute infectious disease or chronic infectious disease activity period\n* A history of uncontrolled seizures, central nervous system disorders, or mental disorders\n* There is a known history of human immunodeficiency virus'}, 'identificationModule': {'nctId': 'NCT06791161', 'briefTitle': 'A Multicenter Prospective Cohort Study of Adjuvant Therapy for BRCA1/2 Mutated Hormone Receptor-positive HER2-negative Early High-risk Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, 'officialTitle': 'A Multicenter Prospective Cohort Study of Adjuvant Therapy for BRCA1/2 Mutated Hormone Receptor-positive HER2-negative Early High-risk Breast Cancer', 'orgStudyIdInfo': {'id': 'NCC5094'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BRCA1/2 mutated HR+HER2- early high-risk breast cancer', 'interventionNames': ['Drug: Endocrine drug +CDK4/6 inhibitor or PRAP inhibitor or Endocrine drug +CDK4/6 inhibitor+PARP inhibitor']}], 'interventions': [{'name': 'Endocrine drug +CDK4/6 inhibitor or PRAP inhibitor or Endocrine drug +CDK4/6 inhibitor+PARP inhibitor', 'type': 'DRUG', 'description': 'BRCA1/2 mutated hormone receptor-positive HER2-negative early high-risk breast cancer is treated with 3 3 treatment options after surgery：Endocrine drug +CDK4/6 inhibitor or PRAP inhibitor or Endocrine drug +CDK4/6 inhibitor+PARP inhibitor', 'armGroupLabels': ['BRCA1/2 mutated HR+HER2- early high-risk breast cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Cancer Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of department', 'investigatorFullName': 'PENG YUAN', 'investigatorAffiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}}}}