Ignite Creation Date:
2025-12-24 @ 11:06 PM
Ignite Modification Date:
2025-12-31 @ 12:29 PM
Study NCT ID:
NCT05033769
Status:
UNKNOWN
Last Update Posted:
2023-04-18
First Post:
2020-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing ImmunoResponse Post Eribulin: Eribulin and Immunogenicity in Advanced 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': 'C490954', 'term': 'eribulin'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 82}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-14', 'studyFirstSubmitDate': '2020-06-19', 'studyFirstSubmitQcDate': '2021-08-30', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immune responsivity (IR)', 'timeFrame': '12 weeks after therapy start', 'description': 'defined as ≥ 5% of all T cells from peripheral blood are Ki-67 positive after chemotherapy'}], 'secondaryOutcomes': [{'measure': 'Overall response after three months', 'timeFrame': 'three months after therapy start', 'description': 'Overall response'}, {'measure': 'Progression free survival', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months', 'description': 'Progression free survival'}, {'measure': 'Overall survival', 'timeFrame': 'From date of randomization until the date of death from any cause, whichever came first, assessed up to 24 months', 'description': 'Overall survival'}, {'measure': 'Toxicity and safety of eribulin and paclitaxel', 'timeFrame': 'Therapy start until 30 days post last dose', 'description': 'Toxicity and safety of eribulin and paclitaxel'}, {'measure': 'EORTC QLQC30', 'timeFrame': 'Therapy start until therapy end after 4 cycles up to 12 weeks', 'description': 'Quality of life assessed via EORTC QLQC30'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunoresponse'], 'conditions': ['Breast Cancer Female', 'Neoplasm, Breast', 'Breast Cancer Metastatic']}, 'descriptionModule': {'briefSummary': 'After progression of disease after one chemotherapy, metastatic breast cancer patients will be randomized 1:1 to one of the following treatment arms:\n\nArm A. Eribulin Arm B. Paclitaxel\n\nBlood draws for immune analysis will be performed before start of therapy, on day 1 of cycle 2 and on day 21 of cycle 4 (end of therapy) for the primary study aim. Patients will be treated under study conditions for a maximum of 4 therapy cycles.', 'detailedDescription': 'This is a prospective, randomized Phase IV study. Patients who progressed after one chemotherapy in the metastatic setting will be randomized 1:1 to one of the following treatment arms. Arm A. Eribulin 1.23 mg/m2 on days 1 and 8 q21d Arm B. Paclitaxel 80 mg/m2 on days 1, 8, and 15 q21d Blood draws for immune analysis will be performed before start of therapy on day 1 of cycle 1, on day 1 of cycle 2 (pre dose each) and on day 21 of cycle 4 (end of therapy) and assessed for the primary study aim. Patients will be treated under study conditions for a maximum of 4 therapy cycles.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent prior to beginning of trial specific procedures\n* Subject must be female and aged ≥ 18 years on day of signing informed consent\n* ECOG 0-1\n* Histologically confirmed, HER2 negative breast cancer determined by core biopsy of tumor lesion. Human epidermal growth factor receptor 2 (HER2) negativity is defined as either of the following by local laboratory assessment: In situ hybridization (ISH) non-amplified (ratio ≤ 2.2), or IHC 0 or IHC 1+.\n* Indication for chemotherapy\n* Previous therapy with one chemotherapy line\n* Target lesion (RECIST 1.1)\n* Adequate organ function defined as:\n\nCreatinine Clearance \\> 50 ml/min ANC ≥ 1.5 x 10 3 /μL Thrombocytes \\> 100 x 10 3 /μL\n\nExclusion Criteria:\n\n* HER2 positive disease\n* Indication for an anti-hormone treatment\n* Active infection requiring systemic therapy.\n* Active autoimmune disease or other diseases that requires systemic treatment with corticosteroids or immunosuppressive drugs.\n* History of primary or acquired immunodeficiency (including allogenic organ transplant).\n* Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).\n* Severely impaired liver function (Child Pugh C)\n* Hypersensitivity to study medication or any of its components\n* Neuropathy (PNP) \\> Grade 2 (CTCAE 5.0)\n* Congenital long QT syndrome\n* Preexisting concomitant use of strong CYP3A4 and CYP2C8 inhibiting or inducing drugs\n* Life expectancy of less than three months\n* Pregnancy (contraception is required according tocontraceptive guidance)\n* Lactation\n* Known history of following infections: Human immunodeficiency virus (HIV), History of acute or chronic Hepatitis B or Hepatitis C\n* Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.\n* Does not agree to blood collection"}, 'identificationModule': {'nctId': 'NCT05033769', 'acronym': 'AIRE', 'briefTitle': 'Assessing ImmunoResponse Post Eribulin: Eribulin and Immunogenicity in Advanced Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Institut fuer Frauengesundheit'}, 'officialTitle': 'AIRE - Assessing ImmunoResponse Post Eribulin: Eribulin and Immunogenicity in Advanced Breast Cancer - a Prospectively Randomized Phase IV Study', 'orgStudyIdInfo': {'id': 'IFG-06-2019'}, 'secondaryIdInfos': [{'id': '2020-001938-35', 'type': 'EUDRACT_NUMBER'}, {'id': 'AGO-B-049', 'type': 'OTHER', 'domain': 'AGO-B-ID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eribulin', 'description': 'Arm A. Eribulin 1.23 mg/m\\^2, administered as an injection on day 1 and 8 q 21d for a maximum of 4 therapy cycles', 'interventionNames': ['Drug: Eribulin Injection [Halaven]']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paclitaxel', 'description': 'Paclitaxel 80 mg/m\\^2, administered as an injection on day 1, 8 and 15 q21d for a maximum of 4 therapy cycles', 'interventionNames': ['Drug: Paclitaxel injection']}], 'interventions': [{'name': 'Eribulin Injection [Halaven]', 'type': 'DRUG', 'otherNames': ['Eribulin'], 'description': 'on days 1 and 8 q21d', 'armGroupLabels': ['Eribulin']}, {'name': 'Paclitaxel injection', 'type': 'DRUG', 'otherNames': ['Paclitaxel'], 'description': 'on days 1, 8, and 15 q21d', 'armGroupLabels': ['Paclitaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Andreas Hartkopf, MD, Prof.', 'role': 'CONTACT', 'email': 'andreas.hartkopf@med.uni-tuebingen.de', 'phone': '+49 07071 29 82211'}], 'facility': 'Department of Gynecology, Tübingen University Hospital', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '91054', 'city': 'Erlangen', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Peter A Fasching, Prof. Dr.', 'role': 'CONTACT', 'email': 'peter.fasching@uk-erlangen.de', 'phone': '+49 9131 85', 'phoneExt': '43470'}], 'facility': 'Department of Gynecology and Obstetrics, Erlangen University Hospital', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'centralContacts': [{'name': 'AIRE Study manager', 'role': 'CONTACT', 'email': 'aire@ifg-erlangen.de', 'phone': '+49 (0) 9131 927 9578'}], 'overallOfficials': [{'name': 'Peter A Fasching, MD, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Gynecology and Obstetrics, Erlangen University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut fuer Frauengesundheit', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eisai GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}