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| Name | Class |
|---|---|
| University of Zurich | OTHER |
| Palleos Healthcare GmbH | INDUSTRY |
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This project will engage anti-HER2 directed Trastuzumab biosimilar with a novel quality of ePRO and enable comparison of reliable reference real world patient data, thereby creating a basis for analytic research in order to promote the quality and efficiency of treatment
Comprehensive data on patient history and follow-up modalities, AEs and outcome will be collected as ePRO to provide high-quality reports and quantitatively abundant data provided by patients. In particular, prospectively collected data shall be compared to previously collected ePRO from women treated for HER2-positive BC in a variety of indications and settings . Since a large number of data entries for wellbeing and symptom reporting (according to CTCAE) is available from these patients, the investigators will refer to this as a historic registry data warehouse. Accordingly, the ePRO from these patients treated for HER2 positive BC are available for planned comparative analysis and shall be applied to indicate differences in anti-HER2 directed medication between Ogivri and Herceptin.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events (AE) according to the Common Terminology Criteria for Adverse Events (CTCAE) | AEs according to the Common Terminology Criteria for Adverse Events (CTCAE) after six weeks as documented by the patients as ePRO via Consilium CareTM app. | six weeks |
| Severity of adverse events (AE) according to the Common Terminology Criteria for Adverse Events (CTCAE) | AEs according to the Common Terminology Criteria for Adverse Events (CTCAE) after six weeks as documented by the patients as ePRO via Consilium CareTM app. | six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Wellbeing | According to grades 0-4 (avoiding grade 5 = death) of an ECOG (Eastern Cooperative Oncology Group) Performance Status Scale, here the values are: min 0.1; max 10: higher scores in the particular utility arrangement on this app mean a better outcome. | six weeks |
| EQ-5D-5L (European Quality of Life 5 Dimensions 5 Level Version); descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain and anxiety. Each dimension has 5 levels: (min 1; max 5); higher scores mean a worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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HER2 positive Breast cancer patients undergoing Anti-HER2 treatment with Ogivri
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Trojan, M.D. | Seespital Horgen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andreas Trojan | Horgen | Canton of Zurich | 8010 | Switzerland | ||
| ZeTup |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38573759 | Derived | Trojan A, Roth S, Atassi Z, Kiessling M, Zenhaeusern R, Kadvany Y, Schumacher J, Kullak-Ublick GA, Aapro M, Eniu A. Comparison of the Real-World Reporting of Symptoms and Well-Being for the HER2-Directed Trastuzumab Biosimilar Ogivri With Registry Data for Herceptin in the Treatment of Breast Cancer: Prospective Observational Study (OGIPRO) of Electronic Patient-Reported Outcomes. JMIR Cancer. 2024 Apr 4;10:e54178. doi: 10.2196/54178. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Quality of Live questionnaire will be sent to patients q 3 weeks |
| six weeks |
| Unplanned Consultations | Unplanned consultations are defined as additional consultations outside of planned therapy or control visits | nine weeks |
| Rapperswil-Jona |
| 8640 |
| Switzerland |
| Onkologiepraxis Bellvue | Zurich | 8001 | Switzerland |
| D017437 |
| Skin and Connective Tissue Diseases |