Breast Cancer Clinical Trial
— PROVIDENCEOfficial title:
Prospective Non-interventional Study (NIS) to Examine Patient-reported Outcomes and Real-world Clinical Data in Patients With HER2-positive or HER2-low Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan
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 unresectable or metastatic breast cancer (BC) and in patients with documented HER2-low unresectable or metastatic 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).
Status | Recruiting |
Enrollment | 800 |
Est. completion date | December 31, 2030 |
Est. primary completion date | December 31, 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 130 Years |
Eligibility | Inclusion Criteria: - Adults = 18 years old - Patients with pathologically documented breast cancer that: - is unresectable or metastatic - has confirmed HER2+ or HER2-low tumor status by local pathology - was previously treated with one anti-HER2 directed therapy if the tumor is HER2+ or - 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. - Has documented radiologic progression (during or after most recent treatment) - Patient is eligible for T-DXd treatment in line with the specifications mentioned in the ENHERTU® SmPC and is scheduled for T-DXd as second line treatment if the tumor is HER2+ or scheduled for T-DXd treatment if the tumor is HER2 low* - Patient is able to read and understand either German or English - Signed written informed consent *The prescription of the medicinal products are clearly separated from the decision to include the patient in this NIS. Exclusion Criteria: - Known hypersensitivity to T-DXd or any of the excipients of the drug - Pregnancy or breast feeding - Current or planned participation in an interventional clinical trial - Current or planned systemic treatment of any tumor other than unresectable or metastatic BC |
Country | Name | City | State |
---|---|---|---|
Germany | Research Site | Amberg | |
Germany | Research Site | Ansbach | |
Germany | Research Site | Aschaffenburg | |
Germany | Research Site | Augsburg | |
Germany | Research Site | Bad Reichenhall | |
Germany | Research Site | Baden-Baden | |
Germany | Research Site | Beremerhaven | |
Germany | Research Site | Berlin | |
Germany | Research Site | Bielefeld | |
Germany | Research Site | Bonn | |
Germany | Research Site | Brandenburg an der Havel | |
Germany | Research Site | Braunschweig | |
Germany | Research Site | Bremen | |
Germany | Research Site | Donauwoerth | |
Germany | Research Site | Dortmund | |
Germany | Research Site | Eggenfelden | |
Germany | Research Site | Erfurt | |
Germany | Research Site | Essen | |
Germany | Research Site | Filderstadt - Bonlanden | |
Germany | Research Site | Freudenstadt | |
Germany | Research Site | Fuerstenwalde | |
Germany | Research Site | Gerlingen | |
Germany | Research Site | Giessen | |
Germany | Research Site | Hamburg | |
Germany | Research Site | Hannover | |
Germany | Research Site | Hannover | |
Germany | Research Site | Heidenheim | |
Germany | Research Site | Heilbronn | |
Germany | Research Site | Hildesheim | |
Germany | Research Site | Homburg/Saar | |
Germany | Research Site | Karlsruhe | |
Germany | Research Site | Kassel | |
Germany | Research Site | Kiel | |
Germany | Research Site | Kulmbach | |
Germany | Research Site | Landshut | |
Germany | Research Site | Leer | |
Germany | Research Site | Leipzig | |
Germany | Research Site | Loerrach | |
Germany | Research Site | Lüneburg | |
Germany | Research Site | Magdeburg | |
Germany | Research Site | Mainz | |
Germany | Research Site | Moenchengladbach | |
Germany | Research Site | Mühlhausen | |
Germany | Research Site | Mutlangen | |
Germany | Research Site | Neumarkt | |
Germany | Research Site | Oldenburg | |
Germany | Research Site | Oranienburg | |
Germany | Research Site | Potsdam | |
Germany | Research Site | Regensburg | |
Germany | Research Site | Rosenheim | |
Germany | Research Site | Rotenburg (Wuemme) | |
Germany | Research Site | Schwaebisch-Hall | |
Germany | Research Site | Singen | |
Germany | Research Site | Solingen | |
Germany | Research Site | Stuttgart | |
Germany | Research Site | Torgau | |
Germany | Research Site | Troisdorf | |
Germany | Research Site | Ulm | |
Germany | Research Site | Weinheim | |
Germany | Research Site | Westerstede | |
Germany | Research Site | Wiesbaden | |
Germany | Research Site | Winnenden | |
Germany | Research Site | Zittau |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca | Daiichi Sankyo |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in HRQoL based on FACT-B questionnaire compared to baseline over time | 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). | Patient questionnaires will be collected at time points synchronised with clinic visits during study, assessed up to 60 months | |
Other | Change in HRQoL based on EQ-5D questionnaire compared to baseline over time | Defined as changes in EQ-5D (subscale domains and VAS) at different timepoints compared to baseline.
EQ-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. |
Patient questionnaires will be collected at time points synchronised with clinic visits during study, assessed up to 60 months | |
Other | Real-world Overall Response Rate (rwORR) | rwORR is defined as percentage of patients having complete response or partial response as best response as determined by the investigator | 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 | |
Other | Real-world Progression-free Survival (rwPFS) | 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 | 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 | |
Other | Real-world Overall Survival (rwOS) | rwOS is defined as time from T-DXd initiation to date of death | From first dose of T-DXd until death of any cause, assessed up to 60 months | |
Other | Real-world Time To Treatment Discontinuation (rwTTD) | rwTTD is defined as time from T-DXd initiation to discontinuation, or death | 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 | |
Other | Real-world Time To Next Treatment 2 | rwTTNT2 is defined as time from initiation of T-DXd treatment to initiation of second next treatment, or death | 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 | |
Other | Real-world Time to Treament Discontinuation 2 (rwTTD2) | rwTTD2 is defined as time from initiation T-DXd treatment to discontinuation of corresponding subsequent therapy, or death | 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 | |
Other | Real-world Progression-free Survival (rwPFS2) | 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 | 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 | |
Other | Safety: Collection of Adverse Events (AE) | Safety evaluated based on type of Adverse Event (AE), intensity, causal relationship to treatment, duration, handling, outcome, and seriousness | during routine visits, up to 60 months | |
Other | T-DXd dose modifications | To evaluate treatment modifications in patients treated with T-DXd in a real-world setting | during routine visits, up to 60 months | |
Other | Description of DiGA user and non-user population | 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 | assessed up to 60 months | |
Primary | Real-world Time To Next Treatment (rwTTNT1) | rwTTNT1 is defined as the time from T-DXd initiation to initiation of subsequent therapy | From first dose of T-DXd until initiation of subsequent therapy or death of any cause, whichever came first, assessed up to 60 months | |
Secondary | Change in HRQoL based on FACT-B questionnaire at 6 months after baseline | 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. | 6 months | |
Secondary | Change in HRQoL based on FACT-G questionnaire at 6 months after baseline | 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. | 6 months |
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