Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-29 @ 4:33 AM
Study NCT ID:
NCT03430466
Status:
TERMINATED
Last Update Posted:
2020-08-12
First Post:
2018-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti PD-L1 Antibody + Anti CTLA-4 Antibody in Combination With Hormone Therapy in Patients With Hormone Receptor Positive HER2-negative Recurrent or Metastatic 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Recruiting was not possible', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-10', 'studyFirstSubmitDate': '2018-02-06', 'studyFirstSubmitQcDate': '2018-02-06', 'lastUpdatePostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate based on RECIST1.1', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the safety and efficacy of anti PD-L1 antibody + anti CTLA-4 antibody in combination with hormone therapy in patients with hormone receptor positive HER2-negative recurrent or metastatic breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged \\>= 20 years at informed consent.\n2. Patients who have provided written informed consent themselves.\n3. Patients who have metastatic and/or advanced lesion\n4. Documentation of ER-positive and/or PR-positive tumor (\\>=1% positive stained cells).\n5. Patients with cancer confirmed to be HER2-negative.\n6. Patients with confirmed menopause\n7. Patients who have plans of 2nd hormone therapy.\n8. Patients with a measurable lesion based on RECIST 1.1\n9. Patients with ECOG PS of 0 to 1.\n10. Patients without any severe disorder in the major organs.\n\nExclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n1. Active or prior documented autoimmune disease within the past 2 years.\n2. Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab\n3. Patients with central nervous system metastasis\n4. Patients with life-threatening disease.\n5. Patients with a history of treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA-4 antibody drug.\n6. Patients who have received live vaccination within 30 days before start of the investigational products.\n7. Patients with a past medical history of pneumonia requiring steroid treatment or with a past medical history of interstitial pneumonia.\n8. Patients considered ineligible for participation in this study by their attending physicians.'}, 'identificationModule': {'nctId': 'NCT03430466', 'briefTitle': 'Anti PD-L1 Antibody + Anti CTLA-4 Antibody in Combination With Hormone Therapy in Patients With Hormone Receptor Positive HER2-negative Recurrent or Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Kyoto Breast Cancer Research Network'}, 'officialTitle': 'Phase II Study to Assess Efficacy, Safety & Immunological Biomarker of Anti PD-L1 Antibody + Anti CTLA-4 Antibody in Combination With Hormone Therapy in Patients With Hormone Receptor Positive HER2-negative Recurrent or Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'kbcrnb001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Durvalmab&Tremelimumab&Fulvestrant', 'description': 'Durvalmab\\&Tremelimumab\\&Fulvestrant', 'interventionNames': ['Drug: Durvalmab&Tremelimumab&Fulvestrant']}], 'interventions': [{'name': 'Durvalmab&Tremelimumab&Fulvestrant', 'type': 'DRUG', 'description': 'Durvalumab and Tremelimumab once in 4 weeks Durvalumab for 13 months Tremelimumab for initial 4 months Fulvestrant : At baseline, then week 2, week 4 and after that every 4 weeks', 'armGroupLabels': ['Durvalmab&Tremelimumab&Fulvestrant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '606-8507', 'city': 'Kyoto', 'country': 'Japan', 'facility': 'Kyoto University Hospital', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyoto Breast Cancer Research Network', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}