A Study to Assess Treatment Patterns and Treatment Adherence in Early HER2-positive Breast Cancer Participants After Treatment Decentralization
Recruiting · NCT07527741 · Observational (researchers observe without assigning treatment) · Lead sponsor: Hoffmann-La Roche
View the official record on ClinicalTrials.gov →What this trial is about
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 take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
10 locations listed.
- Health Centre Loznica - Loznica, Bolnička 65, Serbia
- General Hospital Požarevac - Požarevac, Bratstva Jedinstva 135, Serbia
- Healthcare Centre Bor - Bor, Dragiše Mišovića 1, Serbia
- Health Centre Kladovo - Kladovo, Dunavska 1-3, Serbia
- Health Centre ''Sveti Luka'' Smederevo - Smederevo, Knez Mihailova 51, Serbia
- General Hospital Pančevo - Pančevo, Miloša Trebinjca 11, Serbia
- Institute for Onocology and Radiology of Serbia - Belgrade, Pasterova 14, Serbia
- General Hospital "Dr Laza K. Lazarevic" Sabac - Šabac, Popa Karana 2-4, Serbia
- Health Centre Valjevo - Valjevo, Sinđelićeva 62, Serbia
- General Hospital ''Stefan Visoki'' Smederevska Palanka - Smederevska Palanka, Vuka Karadžića 147, Serbia