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NCT07527741
A Study to Assess Treatment Patterns and Treatment Adherence in Early HER2-positive Breast Cancer Participants After Treatment Decentralization
Conditions: Early-stage HER2+ Breast Cancer
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 100
Sponsor: Hoffmann-La Roche
Location: Health Centre Loznica Loznica Bolnička 65
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.
Eligibility Criteria
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, Smederevo, Smederevska Palanka, Šabac, Valjevo)
* Participants administratively belonging to the following secondary centers: Bor, Kladovo, Loznica, Pančevo, Požarevac, Smederevo, Smederevska Palanka, Šabac, or Valjevo, who initiated neoadjuvant therapy at IORS instead of their local secondary center
Source: ClinicalTrials.gov (NCT07527741). StuddyBuddy aggregates publicly available trial information.