Evaluation of the digital health application medidux™ in patients with HER2-positive breast cancer during chemotherapy in combination with HER2-targeted therapy (including tyrosine kinase inhibitors [TKI]) or therapy with an antibody-drug conjugate: A multicenter, randomized, controlled study

Identifiant de l'essai ICTRP
NCT05425550 (ICTRP)

Titre officiel (approuvé par le comité d'éthique)
Evaluation der digitalen Gesundheitsanwendung medidux™ bei PatientInnen mit HER2-positivem Brustkrebs während einer Chemotherapie in Kombination mit einer HER2-zielgerichteten Therapie (in-klusive Tyrosinkinase-Inhibitoren [TKI]) oder einer Therapie mit einem Antikörper-Wirkstoff-Konjugat: Eine multizentrische, randomisierte, kontrollierte Studie (BASEC)

Titre académique
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. (ICTRP)

Titre public
Evaluation of the Medidux Digital Health Application in Patients With HER2-positive Breast Cancer During Chemotherapy in Combination With HER2-targeted Therapy or Antibody-drug Conjugate Therapy. (ICTRP)

Maladie en cours d'investigation
Breast Cancer (ICTRP)

Intervention étudiée
Device: medidux app (ICTRP)

Type d'essai
Interventional (ICTRP)

Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). (ICTRP)

Critères d'inclusion/exclusion
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. (ICTRP)

non disponible

Critères d'évaluation principaux et secondaires
Number of Adverse events (AEs) (CTCAE severity >2) and serious AEs (SAE) within the observation period. (ICTRP)

Adverse events (AE) occurring in the observation period recorded and assessed by the investigator during the scheduled study visits.;Serious adverse events (SAEs);Number of patients with at least one documented chemotherapy (CTX) respectively antibody-drug conjugate dose reduction.;CTX respectively antibody-drug conjugate adherence;Number of treatment-associated unplanned emergency consultations;Number of hospitalisations;Number and severity of symptoms recorded by medidux� in the experimental arm.;Adherence (ICTRP)

Date d'enregistrement
non disponible

Inclusion du premier participant
non disponible

Sponsors secondaires
Mobile Health AG (ICTRP)

Contacts supplémentaires
Andreas Trojan, Prof. Dr. med.;Peter Fasching, Prof. Dr. med.;Palleos Healthcare GmbH;Andreas Trojan, Prof. Dr. med., info@palleos.com, +49(0)61195019;, Seespital Horgen-Onkologie,Universit?tsklinikum Erlangen, Frauenklinik, (ICTRP)

ID secondaires
PRO2 (ICTRP)

Résultats-Données individuelles des participants
non disponible

Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT05425550 (ICTRP)