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App aims to tame chemo side effects in breast cancer

NCT ID NCT05425550

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

196 people

The number who actually took part.

Started

Aug 2022

Finished

Jun 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Seespital Horgen-Onkologie

    Horgen, 8810, Switzerland

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