Clinical trial · Interventional
Evaluation of the Medidux™ Digital Health Application in Patients With HER2-positive Breast Cancer.
Evaluation of the Medidux™ Digital Health Application in Patients With HER2-positive Breast Cancer During Chemotherapy in Combination With HER2-targeted Therapy (Including Tyrosine Kinase Inhibitors [TKI]) or an Antibody-drug Conjugate Therapy: a Multicenter Randomized Controlled Trial.
NCT05425550CI-TRIAL-00095557PRO2terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was discontinued due to low recruitment rates. Despite various measures, such as training courses and workshops, recruitment rates could not be improved in the long term.
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| medidux™ app | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Experimental group is using the medidux™ app
- interventionNames
- Device: medidux™ app
- type
- NO_INTERVENTION
- label
- Arm B
- description
- Control group does not use the medidux™ app
Primary outcomes (1)
- measure
- Number of Adverse events (AEs) (CTCAE severity >2) and serious AEs (SAE) within the observation period.
- timeFrame
- From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days)
- description
- As the primary endpoint, the occurrence of adverse events, either of type SAE or of type AE with CTCAE severity \>2, with a start date within the observation period will be measured for each patient. In the following, these events are referenced as high-grade AEs (HAE). The parameters included in the primary endpoint analysis are recorded by the investigator during regular study visits within 12 weeks. The observation period can, however, be extended to the period required for the completion of the initially planned therapy due to shifts in therapy; the maximum observation period is limited to 16 weeks. Adverse events are mapped to the hierarchy and thesaurus terms of the Medical Dictionary for Regulatory Activities (MedDRA, latest version). Severity will be determined according to NCI CTCAE v5.0. In addition to the assessment by the investigators and the medical monitor, the HAEs will be assessed by a blinded medical expert (Adjudicator) and a classification is made independently.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with signed informed consent. 2. Female and male patients, age at diagnosis 18 years and older. 3. Patients with HER2-positive breast carcinoma\* (confirmed by a local pathologist). 4. Patients with breast carcinoma with positive or negative hormone receptor status. 5. 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. 6. ECOG performance Status ≤ 1. 7. Sufficient command of the German language as assessed by the investigator. 8. 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 Criteria: 1. Patients for whom it is questionable whether they will follow the study protocol, e.g., due to psychological problems or their private life situation. 2. Patients with insufficient knowledge about the use of smartphones. 3. Patients at the start of therapy with an ECOG performance status ≥ 2. 4. Patients who have already used the medidux™ app or its predecessor consilium care™ before admission to the study. 5. 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. 6. Simultaneous participation in an interventional clinical trial.
References
Publications (23)
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