Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-01-01 @ 4:21 AM
Study NCT ID:
NCT07049133
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-09
First Post:
2025-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Toxicity Markers to Trastuzumab-Deruxtecan (T-DXd) In Patients With 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-03', 'studyFirstSubmitDate': '2025-06-25', 'studyFirstSubmitQcDate': '2025-06-25', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of mean levels of cytokine and T-DXd toxicity', 'timeFrame': '2 years', 'description': 'cytokine quantification in blood sample collected at baseline and before cycle 3 day 1'}], 'secondaryOutcomes': [{'measure': 'Incidence of T-DXd Treatment Adverse Events', 'timeFrame': '2 years', 'description': 'Adverse event (AE) collection with particular focus on ILD/pneumonitis and any other Grade 3 (G3) AE'}, {'measure': 'T-DXd activity evaluation', 'timeFrame': '8 months', 'description': 'collection of tumor assessment data during T-DXd therapy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metastatic Breast Cancer', 'Trastuzumab-Deruxtecan', 'ILD/pulmonitis'], 'conditions': ['Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'the anti-Human Epidermal Growth Factor Receptor 2 (HER2) Trastuzumab-Deruxtecan (T-DXd) has shown impressive clinical activity in pretreated patients with metastatic breast cancer (MBC) but is also associated with a non-negligible rate of adverse events that may lead to treatment discontinuation and/or the onset of pneumonitis/interstitial lung disease (ILD)\n\nThe aim of the study is to identify and describe potentially predictive markers related to the onset of relevant T-DXd-related toxicities', 'detailedDescription': 'Despite advanced in diagnosis and in the treatment management, advanced breast cancer (ABC) is still an incurable disease.\n\nRecent pharmaceutical developments have changed treatment algorithms in MBC and have further improved the overall prognosis of patients which exploit the tumor-targeting activity of monoclonal antibodies to deliver at the tumor site potent chemotherapeutic agents that would otherwise be exceedingly toxic if delivered systemically.\n\nAmong them, new effective anticancer drugs, such as Trastuzumab-Deruxtecan (T-DXd), have revolutionized the clinical management of HER2-positive and HER2-low ABC. However, this drug is associated with a non-negligible rate of adverse events that can lead to treatment discontinuation and/or the onset of pneumonitis/interstitial lung disease (ILD), a potentially fatal adverse event.\n\nThe aim of the study is to identify and describe potentially predictive markers related to the onset of relevant T-DXd-related toxicities (both any grade ILD/pneumonitis and any toxicity of grade ≥3) in a population of patients treated with T-DXd according to standard clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'male or female advanced breast cancer patient, either HER2-positive or HER2-low/ultralow, candidate to receive T-DXd as per standard practice', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, aged at least 18 years.\n* Histologically documented invasive breast cancer, either HER2-positive or HER2-low/ultralow.\n* Candidate to receive T-DXd as per standard practice.\n* Consent for the provision of blood samples for exploratory analyses.\n\nExclusion Criteria:\n\n* Operable, non-metastatic breast cancer\n* Unwillingness to provide additional blood draws'}, 'identificationModule': {'nctId': 'NCT07049133', 'acronym': 'Tox-DXd', 'briefTitle': 'Toxicity Markers to Trastuzumab-Deruxtecan (T-DXd) In Patients With Advanced Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'European Institute of Oncology'}, 'officialTitle': 'Identification Of Toxicity Markers to Trastuzumab-Deruxtecan (T-DXd) In Patients With Advanced Breast Cancer. Tox-DXd: a Prospective, Observational Study', 'orgStudyIdInfo': {'id': 'L2-335'}, 'secondaryIdInfos': [{'id': 'UID4972', 'type': 'OTHER', 'domain': 'Clinical Trial Office - Istituto Europeo di oncologia'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'HER2-positive or HER2- low/ultralow metastatic patient', 'description': 'Candidate to receive T-DXd as per standard practice for HER2-positive or HER2- low/ultralow advanced breast cancer.', 'interventionNames': ['Other: T-DXd toxicity marker identification']}], 'interventions': [{'name': 'T-DXd toxicity marker identification', 'type': 'OTHER', 'description': 'to find potential predictive markers associated with T-DXd-related toxicities', 'armGroupLabels': ['HER2-positive or HER2- low/ultralow metastatic patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20141', 'city': 'Milan', 'country': 'Italy', 'contacts': [{'name': 'Elisabetta Munzone, MD', 'role': 'CONTACT'}], 'facility': 'European Institute of Oncolgy', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Elisabetta Munzone, MD', 'role': 'CONTACT', 'email': 'elisabetta.munzone@ieo.it', 'phone': '+39 0257489405'}, {'name': 'Davide Merli, PHD', 'role': 'CONTACT', 'email': 'davide.merli@ieo.it', 'phone': '+39 0294372213'}], 'overallOfficials': [{'name': 'Elisabetta Munzone, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'European Institute of Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Institute of Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}