Status:
TERMINATED
Evaluation of the Medidux™ Digital Health Application in Patients With HER2-positive Breast Cancer.
Lead Sponsor:
Palleos Healthcare GmbH
Collaborating Sponsors:
Mobile Health AG
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Multicenter, prospective, randomised and controlled study to evaluate the medidux™ app during an observation period of 12 weeks (maximum 16 weeks in case of shifts in the initially planned therapy).
Detailed Description
The PRO2 study is being conducted by palleos healthcare GmbH, the sponsor of the study, with the participation of an expected 585 patients at 40 study sites in Germany and 10 study sites in the German...
Eligibility Criteria
Inclusion
- Patients with signed informed consent.
- Female and male patients, age at diagnosis 18 years and older.
- Patients with HER2-positive breast carcinoma\* (confirmed by a local pathologist).
- Patients with breast carcinoma with positive or negative hormone receptor status.
- Patients prior to initiation of neoadjuvant, adjuvant or palliative chemotherapy\*\* in combination with HER2-targeted therapy (including tyrosine kinase inhibitors \[TKI\]) or an antibody-drug conjugate therapy.
- ECOG performance Status ≤ 1.
- Sufficient command of the German language as assessed by the investigator.
- Presence of a personal smartphone with iOS or Android system. The operating system must be updated to the latest, second or third most recent major version and the medidux™ app must be installed prior to the start of the first treatment cycle.
- \* HER2-positive in the context of the study defined as "eligible for an approved HER2-targeted therapy," i.e., in addition to immunohistochemistry (IHC) scores of 3+ and 2+ with positive results of in-situ hybridization (ISH+), also according to new standard HER2 low (IHC 1+ and 2+ with simultaneous negative result of in-situ-hybridization (ISH-))
- \*\* Patients receiving chemotherapy in combination with HER2-targeted therapy as part of a (neo)adjuvant sequence therapy (e.g. as second part after previous EC therapy) may be included. Accordingly, the PRO2 study will not start until patients begin combination of chemotherapy and HER2-targeted therapy.
Exclusion
- Patients for whom it is questionable whether they will follow the study protocol, e.g., due to psychological problems or their private life situation.
- Patients with insufficient knowledge about the use of smartphones.
- Patients at the start of therapy with an ECOG performance status ≥ 2.
- Patients who have already used the medidux™ app or its predecessor consilium care™ before admission to the study.
- Patients with breast carcinoma who are to be treated exclusively with HER2-targeted antibody monotherapy or TKI-therapy without simultaneous chemotherapy. The sole administration of antibody-drug conjugates alone is permitted/prescribed by the SmPC.
- Simultaneous participation in an interventional clinical trial.
Key Trial Info
Start Date :
August 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2025
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT05425550
Start Date
August 29 2022
End Date
June 5 2025
Last Update
September 22 2025
Active Locations (1)
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1
Seespital Horgen-Onkologie
Horgen, Switzerland, 8810