Breast Cancer Clinical Trial
— PRO2Official 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.
NCT number | NCT05425550 |
Other study ID # | PRO2 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 29, 2022 |
Est. completion date | May 31, 2024 |
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).
Status | Recruiting |
Enrollment | 585 |
Est. completion date | May 31, 2024 |
Est. primary completion date | May 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Switzerland | Seespital Horgen-Onkologie | Horgen |
Lead Sponsor | Collaborator |
---|---|
Palleos Healthcare GmbH | mobile Health AG |
Switzerland,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days) | |
Secondary | 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. | From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days) | |
Secondary | 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". | From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days) | |
Secondary | 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. | From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days) | |
Secondary | 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. | From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days) | |
Secondary | 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. | From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days) | |
Secondary | Number of hospitalisations | Number of hospitalisations defined as inpatient admission at the center or at another medical facility because of an (S)AE | From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days) | |
Secondary | 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. | From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days) | |
Secondary | 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. | From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days) |
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