Treatment patterns and adherence after decentralizing care for early HER2-positive breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows people with stage II–III HER2-positive breast cancer who have had curative surgery to compare treatment patterns and adherence after a decentralization of adjuvant care. Participants are grouped by travel burden: one group whose adjuvant therapy location does not increase travel requirements and another who must travel from a secondary to a tertiary center. Data are collected from medical records and participant questionnaires across ten participating Serbian centers to capture treatment delivery, missed doses, and reasons for nonadherence. No investigational treatments are administered; the study analyzes real-world anti-HER2 therapy use under routine clinical care.

Why it matters

Who can join: the full rules

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

Where it's running

• Health Centre Loznica
  Loznica, Bolnička 65, Serbia Recruiting
• General Hospital Požarevac
  Požarevac, Bratstva Jedinstva 135, Serbia Recruiting
• Healthcare Centre Bor
  Bor, Dragiše Mišovića 1, Serbia Recruiting
• Health Centre Kladovo
  Kladovo, Dunavska 1-3, Serbia Recruiting
• Health Centre ''Sveti Luka'' Smederevo
  Smederevo, Knez Mihailova 51, Serbia Recruiting
• General Hospital Pančevo
  Pančevo, Miloša Trebinjca 11, Serbia Recruiting

Study contacts

• Study coordinator: Reference Study ID Number: ML46477 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. Only)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.