App aims to tame chemo side effects in breast cancer
NCT ID NCT05425550
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested a digital health app called medidux™ in 196 people with HER2-positive breast cancer. The app was used for up to 16 weeks during chemotherapy to help track and manage side effects. The goal was to see if using the app reduced the number of severe side effects. However, the study was terminated early, so we have limited data on how well it worked.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- medidux™ digital health application
- What this could lead to
- If it works, this app could help patients and doctors better track and manage chemotherapy side effects, potentially reducing severe complications.
- What could go wrong
- The study was terminated early, so results are limited. The app is a supportive tool, not a treatment, and its benefit over standard care is unproven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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196 people
The number who actually took part.
- Started
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Aug 2022
- Finished
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Jun 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Seespital Horgen-Onkologie
Horgen, 8810, Switzerland
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