A Study to Assess Treatment Patterns and Treatment Adherence in Early HER2-positive Breast Cancer Participants After Treatment Decentralization
Recruiting now
Conditions studied: Early-stage HER2+ Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT07527741
- Run by
- Hoffmann-La Roche
- People needed
- 100
- Starts
- 2026-02-23
- Expected to finish
- 2028-05-31
- Last updated by the study team
- 2026-08-04
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Health Centre Loznica — Loznica, Bolnička 65, Serbia (enrolling)
- General Hospital Požarevac — Požarevac, Bratstva Jedinstva 135, Serbia (enrolling)
- Healthcare Centre Bor — Bor, Dragiše Mišovića 1, Serbia (enrolling)
- Health Centre Kladovo — Kladovo, Dunavska 1-3, Serbia (enrolling)
- Health Centre ''Sveti Luka'' Smederevo — Smederevo, Knez Mihailova 51, Serbia (enrolling)
- General Hospital Pančevo — Pančevo, Miloša Trebinjca 11, Serbia (enrolling)
- Institute for Onocology and Radiology of Serbia — Belgrade, Pasterova 14, Serbia (enrolling)
- General Hospital "Dr Laza K. Lazarevic" Sabac — Šabac, Popa Karana 2-4, Serbia (enrolling)
- Health Centre Valjevo — Valjevo, Sinđelićeva 62, Serbia (enrolling)
- General Hospital ''Stefan Visoki'' Smederevska Palanka — Smederevska Palanka, Vuka Karadžića 147, Serbia (enrolling)
Full record on ClinicalTrials.gov
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