Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 11:34 PM
Study NCT ID:
NCT05573893
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2022-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PROVIDENCE - Prospective Non-interventional Study (NIS) to Examine Patient-reported Outcomes and Real-world Clinical Data in Patients With HER2-positive, HER2-low or HER2-ultralow Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2031-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2022-09-29', 'studyFirstSubmitQcDate': '2022-10-07', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in HRQoL based on FACT-B questionnaire compared to baseline over time', 'timeFrame': 'Patient questionnaires will be collected at time points synchronised with clinic visits during study, assessed up to 60 months', 'description': 'Defined as changes in FACT-B (total score and subscale domains) at different timepoints compared to baseline. The Functional Assessment of Cancer Therapy - Breast (FACT-B) is a 37-item instrument designed to measure five domains of HRQoL in breast cancer patients: Physical, social, emotional, functional well-being as well as a breast-cancer subscale (BCS).'}, {'measure': 'Change in HRQoL based on EQ-5D questionnaire compared to baseline over time', 'timeFrame': 'Patient questionnaires will be collected at time points synchronised with clinic visits during study, assessed up to 60 months', 'description': 'Defined as changes in EQ-5D (subscale domains and VAS) at different timepoints compared to baseline.\n\nEQ-5D is a standardized instrument for use as a measure of patient-reported health outcomes (Euro-QoL). The 5 health-state dimensions in the EQ-5D-5L include: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 5-point scale from 1 (no problem) to 5 (unable to/extreme problems). The EQ-5D-5L also includes a graded (0 to 100) vertical visual analog scale (EQ VAS) on which the participant rates his or her general state of health at the time of the assessment.'}, {'measure': 'Real-world Overall Response Rate (rwORR)', 'timeFrame': 'From first dose of T-DXd until end of T-DXd treatment or death of any cause, whichever came first (investigator-assessed according to clinical routine), assessed up to 60 months', 'description': 'rwORR is defined as percentage of patients having complete response or partial response as best response as determined by the investigator'}, {'measure': 'Real-world Progression-free Survival (rwPFS)', 'timeFrame': 'From first dose of T-DXd until disease progression (investigator-assessed according to clinical routine) or death of any cause, whichever came first, assessed up to 60 months', 'description': 'rwPFS is defined as time from T-DXd initiation to the date of the first source evidence for progression referenced by the clinician (e. g., radiology/ pathology report date) or the date of clinician note when no other corresponding evidence sources were documented) or death, whichever occurs first'}, {'measure': 'Real-world Overall Survival (rwOS)', 'timeFrame': 'From first dose of T-DXd until death of any cause, assessed up to 60 months', 'description': 'rwOS is defined as time from T-DXd initiation to date of death'}, {'measure': 'Real-world Time To Treatment Discontinuation (rwTTD)', 'timeFrame': 'From first dose of T-DXd until discontinuation of T-DXd treatment therapy or death of any cause, whichever came first, assessed up to 60 months', 'description': 'rwTTD is defined as time from T-DXd initiation to discontinuation, or death'}, {'measure': 'Real-world Time To Next Treatment 2 (rwTTNT2)', 'timeFrame': 'From first dose of T-DXd until initiation of second subsequent therapy or death of any cause, whichever came first, assessed up to 60 months', 'description': 'rwTTNT2 is defined as time from initiation of T-DXd treatment to initiation of second next treatment, or death'}, {'measure': 'Real-world Time to Treament Discontinuation 2 (rwTTD2)', 'timeFrame': 'From first dose of T-DXd until discontinuation of corresponding subsequent therapy or death of any cause, whichever came first, assessed up to 60 months', 'description': 'rwTTD2 is defined as time from initiation T-DXd treatment to discontinuation of corresponding subsequent therapy, or death'}, {'measure': 'Real-world Progression-free Survival (rwPFS2)', 'timeFrame': 'From first dose of T-DXd until second disease progression (investigator-assessed according to clinical routine) or death of any cause, whichever came first, assessed up to 60 months', 'description': 'rwPFS2 is defined as time from T-DXd initiation to the date of the first source evidence for the second progression referenced by the clinician (e. g., radiology/ pathology report date) or the date of clinician note when no other corresponding evidence sources were documented) or death, whichever occurs first'}, {'measure': 'Safety: Collection of Adverse Events (AE)', 'timeFrame': 'during routine visits, up to 60 months', 'description': 'Safety evaluated based on type of Adverse Event (AE), intensity, causal relationship to treatment, duration, handling, outcome, and seriousness'}, {'measure': 'T-DXd dose modifications', 'timeFrame': 'during routine visits, up to 60 months', 'description': 'To evaluate treatment modifications in patients treated with T-DXd in a real-world setting'}, {'measure': 'Description of DiGA user and non-user population', 'timeFrame': 'assessed up to 60 months', 'description': 'Age, Education, Family status, depressive mood, diagnostic testing, HR-status, Stage IV at initial diagnosis, localization of metastases, presence or history of (in) active brain metastases, previous therapies, subsequent therapies, center characteristics, DiGA usage'}], 'primaryOutcomes': [{'measure': 'Real-world Time To Next Treatment (rwTTNT1)', 'timeFrame': 'From first dose of T-DXd until initiation of subsequent therapy or death of any cause, whichever came first, assessed up to 60 months', 'description': 'rwTTNT1 is defined as the time from T-DXd initiation to initiation of subsequent therapy'}], 'secondaryOutcomes': [{'measure': 'Change in HRQoL based on FACT-B questionnaire at 6 months after baseline', 'timeFrame': '6 months', 'description': 'To evaluate patient-reported outcomes (PROs)/ health-related quality of life (HRQoL) based on FACT-B questionnaire at 6 months after baseline. The Functional Assessment of Cancer Therapy - Breast (FACT-B) is a 37-item instrument designed to measure five domains of HRQoL in breast cancer patients: Physical, social, emotional, functional well-being as well as a breast-cancer subscale (BCS). FACT-B will be collected electronically at time points synchronized with clinic visits during the study.'}, {'measure': 'Change in HRQoL based on FACT-G questionnaire at 6 months after baseline', 'timeFrame': '6 months', 'description': 'To evaluate patient-reported outcomes (PROs)/ health-related quality of life (HRQoL) based on FACT-G questionnaire at 6 months after baseline. The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire designed to measure four domains of HRQoL in cancer patients: Physical, social, emotional, and functional well-being. FACT-G will be collected electronically at time points synchronized with clinic visits during the study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Trastuzumab-Deruxtecan,', 'Human epidermal growth factor receptor 2 Positive Breast Cancer,', 'Human epidermal growth factor receptor 2 Low Breast Cancer,', 'Human epidermal growth factor receptor 2 Ultralow Breast Cancer,'], 'conditions': ['Breast Neoplasms', 'Breast Cancer', 'Neoplasm Metastasis']}, 'descriptionModule': {'briefSummary': 'This is a prospective non-interventional, multicenter study observing patient reported outcomes as well as real-world efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients with documented Human epidermal growth factor receptor 2 (HER2)-positive, HER2-low or HER2-ultralow unresectable or metastatic breast cancer (BC) receiving T-DXd in line with the applicable summary of product characteristics (SmPC) within routine clinical practice in Germany. In addition, patients will be informed about use of digital healthcare application (DiGA).', 'detailedDescription': 'Eligible participants will be those patients with documented HER2-positive, HER2-low or HER2-ultralow unresectable or metastatic BC receiving T-DXd treatment in line with the applicable summary of product characteristics (SmPC) within routine clinical practice.\n\nAll diagnostic and treatment procedures including visit frequency are at the discretion of the treating physician and not defined by the protocol. T-DXd treatment is considered as a selection criteria. Patients will be informed about use of digital healthcare application (DiGA).\n\nApproximately 800 eligible participants will be enrolled which includes 400 patients in the HER2-positive cohort and 400 patients in the HER2-low/ HER2-ultralow cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with documented Human epidermal growth factor receptor 2 (HER2)-positive, HER2-low or HER2-ultralow unresectable or metastatic breast cancer (BC) receiving T-DXd in line with the applicable summary of product characteristics (SmPC) within routine clinical practice may participate in this NIS.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults ≥ 18 years old\n2. Patients (irrespective of sex and gender) with pathologically documented breast cancer that:\n\n * is unresectable or metastatic\n * has confirmed HER2+, HER2-low or HER2-ultralow tumor status by local pathology\n * was previously treated with one or more anti-HER2 directed therapy if the tumor is HER2+ OR\n * was previously treated with at least one endocrine therapy in the metastatic setting and is not considered suitable for endocrine therapy as the next line of treatment if the tumor is HR+, HER2-low or HER2-ultralow OR\n * was previously treated with prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy if the tumor is HER2-low.\n3. Has documented radiologic progression (during or after most recent treatment)\n4. Patient is eligible for T-DXd treatment in line with the specifications mentioned in the ENHERTU® SmPC and is scheduled for T-DXd treatment \\*\n5. Patient is able to read and understand either German or English\n6. Signed written informed consent\n\n * The prescription of the medicinal product is clearly separated from the decision to include the patient in this NIS.\n\nExclusion Criteria:\n\n1. Start of T-DXd treatment for more than 30 days before enrolment (eCRF registration date)\n2. Known hypersensitivity to T-DXd or any of the excipients of the drug\n3. Pregnancy or breast feeding\n4. Current or planned participation in an interventional clinical trial\n5. Current or planned systemic treatment of any tumor other than unresectable or metastatic BC\n\nPatients who have never received any T-DXd dose will be discontinued from the study and will be considered as a late screening failure, no further documentation besides reason and date of discontinuation is needed.'}, 'identificationModule': {'nctId': 'NCT05573893', 'acronym': 'PROVIDENCE', 'briefTitle': 'PROVIDENCE - Prospective Non-interventional Study (NIS) to Examine Patient-reported Outcomes and Real-world Clinical Data in Patients With HER2-positive, HER2-low or HER2-ultralow Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Prospective Non-interventional Study (NIS) to Examine Patient-reported Outcomes and Real-world Clinical Data in Patients With HER2-positive, HER2-low or HER2-ultralow Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan', 'orgStudyIdInfo': {'id': 'D9673R00028'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Cohort 1 containing patients with documented HER2-positive unresectable or metastatic BC receiving T-DXd treatment in line with the applicable summary of product characteristics (SmPC) within routine clinical practice.'}, {'label': 'Cohort 2', 'description': 'Cohort 2 containing patients with documented HER2-low or HER2-ultralow unresectable or metastatic BC receiving T-DXd treatment in line with the applicable summary of product characteristics (SmPC) within routine clinical practice.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92224', 'city': 'Amberg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.44287, 'lon': 11.86267}}, {'zip': '91522', 'city': 'Ansbach', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.30481, 'lon': 10.5931}}, {'zip': '99510', 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