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Breast CancerPRO2NCT05425550

Evaluation of the Medidux™ Digital Health Application in Patients With HER2-positive Breast Cancer.

A study testing medidux™ app in people with Breast Cancer, run by Palleos Healthcare GmbH at 1 site in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
medidux™ app
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
196 participants
Where
1 siteSwitzerland
Study dates
29 Aug 2022to 5 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Seespital Horgen-Onkologie

    Horgen, 8810

Other trials in Switzerland

About this study

Official title: 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.

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).

Read the 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-speaking part of Switzerland with the aim of investigating the medical benefit of the smartphone application medidux™ (app) with regard to the occurrence of side effects in breast cancer therapy. Furthermore, the potential impact on the application of the chemotherapy or antibody-drug conjugate, respectively, the number of unplanned doctor visits, as well as hospitalizations and how often the app is used will be investigated.

The app was developed by mobile Health AG and is intended to accompany therapy. It is an approved CE-marked medical device that will be used in the study within the intended purpose. Study participants can use the app to document symptoms and well-being, as well as vital signs (e.g., blood pressure), and complete a test that can be used to assess mental performance. The entries can be viewed by the study physician through the medidux™ web application. The study participants can refer to the entries during the treatment visit to explain the course of therapy and perceived symptoms. As part of the study, use of the app will be compared to the normal treatment routine (without the app). A randomization process will determine whether study participants receive the app. The probability of receiving the app is 50%. If study participants receive the app, it can be used after installation on the personal smartphone. The approximately 12- to a maximum of 16-week observation period begins with the regular breast cancer therapy. The specific treatment of the breast cancer is not interfered with during the study, i.e. the administration of the therapy itself is carried out in the same way as it would be without the app.

Conditions
Breast Cancer
Being tested
medidux™ app
Keywords
app, PRO2, medidux, ePro, palleos, xlife science, mobile Health AG, mobile Health, medical device, palleos healthcare
Medical subject headings
Breast Neoplasms, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • medidux™ appDevice

    Use of the regular medidux™ application for 12 (maximum 16) weeks

Study groups in NCT05425550
Study groupRoleWhat they receive
Arm AExperimentalExperimental group is using the medidux™ app
Receives: Device: medidux™ app
Arm BNo interventionControl group does not use the medidux™ app

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Adverse events (AEs) (CTCAE severity >2) and serious AEs (SAE) within the observation period.

    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.

    Measured: From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days)

Secondary outcomes (8)

  1. Adverse events (AE) occurring in the observation period recorded and assessed by the investigator during the scheduled study visits.

    Adverse events (AE) occurring in the observation period recorded and assessed by the investigator during the scheduled study visits. Events classified as "hair loss" (alopecia) are excluded from the analysis as they cannot be influenced a priori by the medidux™ app but may be subject to a technological center bias due to the availability of "cold caps", which cannot be controlled within the scope of the study. Adverse events are mapped to hierarchy and thesaurus terms of the Medical Dictionary for Regulatory Activities (MedDRA, latest version). Severity is determined according to NCI CTCAE v5.0.

    Measured: From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days)

  2. Serious adverse events (SAEs)

    Serious adverse events (SAEs), defined as a subset of the adverse events defined under Outcome 2 that are classified as "serious".

    Measured: From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days)

  3. Number of patients with at least one documented chemotherapy (CTX) respectively antibody-drug conjugate dose reduction.

    Number of patients with at least one documented chemotherapy (CTX) respectively antibody-drug conjugate dose reduction.

    Measured: From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days)

  4. CTX respectively antibody-drug conjugate adherence

    CTX respectively antibody-drug conjugate adherence defined as the percentage of cumulative chemotherapy respectively antibody-drug conjugate dose actually received relative to the planned cumulative dose.

    Measured: From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days)

  5. Number of treatment-associated unplanned emergency consultations

    Unplanned emergency consultations are defined as emergency-related consultations outside of planned treatment or follow-up visits to the treatment center or the investigator, as well as unplanned visits to other physicians or emergency services.

    Measured: From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days)

  6. Number of hospitalisations

    Number of hospitalisations defined as inpatient admission at the center or at another medical facility because of an (S)AE

    Measured: From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days)

  7. Number and severity of symptoms recorded by medidux™ in the experimental arm.

    Number and severity of symptoms recorded by medidux™ (for ePRO modified NCI CTCAE 4.0 subset of 106 items for cancer) in the experimental arm. ePRO symptoms can be continuously documented via the app by the patient.

    Measured: From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days)

  8. Adherence

    Adherence defined for the experimental arm as the percentage of days in the observation period on which any form of use of the medidux™ app took place.

    Measured: From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2022
  2. Study start29 Aug 2022
  3. Primary completion5 Jun 2025
  4. Study completion5 Jun 2025

Why it stopped: 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
196 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05425550
Sponsor's protocol ID
PRO2
Acronym
PRO2
Status last verified
Sep 2025
First submitted
10 Jun 2022
Last updated
22 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000 May 24-31;283(20):2701-11. doi: 10.1001/jama.283.20.2701.

    PubMed 10819955

  • Gnanasakthy A, DeMuro C, Clark M, Haydysch E, Ma E, Bonthapally V. Patient-Reported Outcomes Labeling for Products Approved by the Office of Hematology and Oncology Products of the US Food and Drug Administration (2010-2014). J Clin Oncol. 2016 Jun 1;34(16):1928-34. doi: 10.1200/JCO.2015.63.6480. Epub 2016 Apr 11.

    PubMed 27069082

  • Bennett AV, Jensen RE, Basch E. Electronic patient-reported outcome systems in oncology clinical practice. CA Cancer J Clin. 2012 Sep-Oct;62(5):337-47. doi: 10.3322/caac.21150. Epub 2012 Jul 18.

    PubMed 22811342

  • Prince RM, Atenafu EG, Krzyzanowska MK. Hospitalizations During Systemic Therapy for Metastatic Lung Cancer: A Systematic Review of Real World vs Clinical Trial Outcomes. JAMA Oncol. 2015 Dec;1(9):1333-9. doi: 10.1001/jamaoncol.2015.3440.

    PubMed 26378774

  • Whitney RL, Bell JF, Tancredi DJ, Romano PS, Bold RJ, Wun T, Joseph JG. Unplanned Hospitalization Among Individuals With Cancer in the Year After Diagnosis. J Oncol Pract. 2019 Jan;15(1):e20-e29. doi: 10.1200/JOP.18.00254. Epub 2018 Dec 5.

    PubMed 30523749

  • Brooks GA, Abrams TA, Meyerhardt JA, Enzinger PC, Sommer K, Dalby CK, Uno H, Jacobson JO, Fuchs CS, Schrag D. Identification of potentially avoidable hospitalizations in patients with GI cancer. J Clin Oncol. 2014 Feb 20;32(6):496-503. doi: 10.1200/JCO.2013.52.4330. Epub 2014 Jan 13.

    PubMed 24419123

  • McKenzie H, Hayes L, White K, Cox K, Fethney J, Boughton M, Dunn J. Chemotherapy outpatients' unplanned presentations to hospital: a retrospective study. Support Care Cancer. 2011 Jul;19(7):963-9. doi: 10.1007/s00520-010-0913-y. Epub 2010 May 25.

    PubMed 20499108

  • Henry DH, Viswanathan HN, Elkin EP, Traina S, Wade S, Cella D. Symptoms and treatment burden associated with cancer treatment: results from a cross-sectional national survey in the U.S. Support Care Cancer. 2008 Jul;16(7):791-801. doi: 10.1007/s00520-007-0380-2. Epub 2008 Jan 17.

    PubMed 18204940

  • Dufton PH, Drosdowsky A, Gerdtz MF, Krishnasamy M. Socio-demographic and disease related characteristics associated with unplanned emergency department visits by cancer patients: a retrospective cohort study. BMC Health Serv Res. 2019 Sep 6;19(1):647. doi: 10.1186/s12913-019-4509-z.

    PubMed 31492185

  • Egbring M, Far E, Roos M, Dietrich M, Brauchbar M, Kullak-Ublick GA, Trojan A. A Mobile App to Stabilize Daily Functional Activity of Breast Cancer Patients in Collaboration With the Physician: A Randomized Controlled Clinical Trial. J Med Internet Res. 2016 Sep 6;18(9):e238. doi: 10.2196/jmir.6414.

    PubMed 27601354

  • Basch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA, Schrag D. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. J Clin Oncol. 2016 Feb 20;34(6):557-65. doi: 10.1200/JCO.2015.63.0830. Epub 2015 Dec 7.

    PubMed 26644527

  • Basch E, Deal AM, Dueck AC, Scher HI, Kris MG, Hudis C, Schrag D. Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment. JAMA. 2017 Jul 11;318(2):197-198. doi: 10.1001/jama.2017.7156.

    PubMed 28586821

  • Trojan A, Huber U, Brauchbar M, Petrausch U. Consilium Smartphone App for Real-World Electronically Captured Patient-Reported Outcome Monitoring in Cancer Patients Undergoing anti-PD-L1-Directed Treatment. Case Rep Oncol. 2020 May 12;13(2):491-496. doi: 10.1159/000507345. eCollection 2020 May-Aug.

    PubMed 32518544

  • Pircher M, Winder T, Trojan A. Response to Vemurafenib in Metastatic Triple-Negative Breast Cancer Harbouring a BRAF V600E Mutation: A Case Report and Electronically Captured Patient-Reported Outcome. Case Rep Oncol. 2021 Mar 29;14(1):616-621. doi: 10.1159/000513905. eCollection 2021 Jan-Apr.

    PubMed 33976643

  • Schmalz O, Jacob C, Ammann J, Liss B, Iivanainen S, Kammermann M, Koivunen J, Klein A, Popescu RA. Digital Monitoring and Management of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Treated With Cancer Immunotherapy and Its Impact on Quality of Clinical Care: Interview and Survey Study Among Health Care Professionals and Patients. J Med Internet Res. 2020 Dec 21;22(12):e18655. doi: 10.2196/18655.

    PubMed 33346738

Questions about this trial

What is this clinical trial studying?

A study testing medidux™ app in people with Breast Cancer, run by Palleos Healthcare GmbH at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: 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.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Adverse events (AEs) (CTCAE severity >2) and serious AEs (SAE) within the observation period. (time frame: From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05425550, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.

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