A Study to Assess Treatment Patterns and Treatment Adherence in Early HER2-positive Breast
The main purpose of this study is to evaluate the impact of a decentralized treatment model on treatment adherence in participants with early-stage human epidermal growth factor receptor 2- positive (HER2+) breast cancer (BC). This study has 2 groups: Group 1: Consistent Travel Burden (Cohorts A, C, and D), will includ
| Condition(s) | Early-stage HER2+ Breast Cancer |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | The main purpose of this study is to evaluate the impact of a decentralized treatment model on treatment adherence in participants with early-stage human epidermal growth factor receptor 2- positive (HER2+) breast cancer (BC). This study has 2 groups: Group 1: Consistent Travel Burden (Cohorts A, C, and D), will include participants whose adjuvant therapy location does not increase their travel requirements, and Group 2: Increased Travel Burden (Cohort B), will include participants who must travel from a secondary center to a tertiary center to receive their adjuvant therapy. |
| Who can participate | Inclusion Criteria: * Diagnosis of stage II and III HER2+ eBC according to European Society For Medical Oncology (ESMO) guidelines * Underwent curative-intent surgical resection for BC * Histologically documented HER2-positive BC (determined per American Society of Clinical Oncology \[ASCO\]/College of American Pathologists \[CAP\] guidelines) before or after surgery Exclusion Criteria: * Any medical or psychiatric condition that, in the investigator's opinion, would compromise the participant's ability to provide informed consent or to complete study-related questionnaires * Receipt of prior neoadjuvant or adjuvant therapy for HER2+ BC at a center other than the 10 participating study sites (Bor, Kladovo, Institute for oncology and Radiology of Serbia (IORS), Loznica, Pančevo, Požarevac, |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | Hoffmann-La Roche |
| Locations | Loznica, Bolnička 65, Serbia; Požarevac, Bratstva Jedinstva 135, Serbia; Bor, Dragiše Mišovića 1, Serbia; Kladovo, Dunavska 1-3, Serbia; Smederevo, Knez Mihailova 51, Serbia; Pančevo, Miloša Trebinjca 11, Serbia (+4 more sites) |
| Start date | 2026-02-23 |
| NCT ID | NCT07527741 |
| Official listing | https://clinicaltrials.gov/study/NCT07527741 |