Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-01-01 @ 2:07 PM
Study NCT ID:
NCT07108595
Status:
COMPLETED
Last Update Posted:
2025-08-07
First Post:
2025-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of T-DXd in Patients With HER2-positive and HER2-low Metastatic Breast Cancer: a Real-world Study
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2025-07-31', 'studyFirstSubmitQcDate': '2025-07-31', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': '2 years', 'description': 'Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.'}], 'secondaryOutcomes': [{'measure': 'The Number of Participants Who Experienced Adverse Events (AE)', 'timeFrame': '2 years', 'description': 'Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HER2-positive', 'HER2-low', 'T-DXd', 'Real-world study'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Evaluate the efficacy and safety of T-DXd in patients with HER2-positive and HER2-low metastatic breast cancer', 'detailedDescription': 'The DESTINY-Breast trials established trastuzumab deruxtecan (T-DXd) as a treatment significantly improving outcomes in human epidermal growth factor receptor 2 (HER2)-positive and HER2-low metastatic breast cancer (MBC). However, real-world effectiveness is susceptible to confounding factors. This multicenter, real-world study aims to systematically evaluate the efficacy and safety of T-DXd in patients with HER2-positive and HER2-low MBC. Key clinicopathological parameters were to be integrated to develop an individualized prognostic prediction model, facilitating precision medicine implementation in clinical practice.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with HER2-positive or HER2-low expressing, locally advanced or metastatic breast cancer were eligible and received therapy. DXd was administered intravenously at 5.4 mg/kg every 3 weeks (21-day cycles) until disease progression or unacceptable toxicity. Dose adjustments were performed according to clinical status and treatment tolerance. Complete blood count with hepatic and renal function parameters were monitored before each cycle. Tumor response assessment via RECIST 1.1 criteria was conducted radiologically every two cycles.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. female patients aged ≥18 years;\n2. histologically confirmed HER2-positive (IHC 3+ or IHC 2+/FISH+) or HER2-low (IHC 1+ or IHC 2+/FISH-) disease;\n3. radiologically confirmed recurrent or metastatic disease;\n4. completion of ≥2 cycles of T-DXd therapy;\n5. comprehensive medical documentation;\n6. Eastern Cooperative Oncology Group (ECOG) performance status ≤3;\n7. measurable target lesions according to RECIST 1.1\n\nExclusion Criteria:\n\n1. history of interstitial lung disease\n2. incomplete medical records\n3. concurrent malignancies;\n4. pregnancy or lactation\n5. psychiatric disorders compromising treatment adherence'}, 'identificationModule': {'nctId': 'NCT07108595', 'briefTitle': 'Efficacy and Safety of T-DXd in Patients With HER2-positive and HER2-low Metastatic Breast Cancer: a Real-world Study', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'Efficacy and Safety of T-DXd in Patients With HER2-positive and HER2-low Metastatic Breast Cancer: a Real-world Study', 'orgStudyIdInfo': {'id': '20250729TDXd'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational Group', 'description': 'Patients receive T-DXd', 'interventionNames': ['Drug: T- Dxd']}], 'interventions': [{'name': 'T- Dxd', 'type': 'DRUG', 'description': 'T-DXd based therapy', 'armGroupLabels': ['Observational Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': "Jiangsu Provincial People's Hospital, Nanjing, JiangSu 210000", 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}