Treatment patterns and adherence after decentralizing care for early HER2-positive breast cancer
Real-World Research of Treatment Patterns and Treatment Adherence in Early HER2-positive Breast Cancer in Serbia After Treatment Decentralization (Close2HER)
Hoffmann-La Roche · NCT07527741
This study tests whether moving adjuvant HER2-targeted treatment closer to patients helps people with early-stage HER2-positive breast cancer stick to their therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Hoffmann-La Roche (industry) |
| Locations | 10 sites (Loznica, Bolnička 65 and 9 other locations) |
| Trial ID | NCT07527741 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are people with stage II–III, histologically confirmed HER2-positive early breast cancer who underwent curative-intent surgery and receive adjuvant care at one of the participating Serbian centers.
Not a fit: Patients who received prior neoadjuvant or adjuvant HER2 therapy at non-participating centers, those administratively belonging to excluded secondary centers, or those unable to provide informed consent or complete questionnaires are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, decentralizing adjuvant HER2 therapy could improve treatment adherence, reduce travel-related barriers, and potentially improve patient outcomes.
How similar studies have performed: Decentralization and access programs in oncology have sometimes improved adherence and access in other settings, but randomized evidence specifically in early HER2-positive breast cancer is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Loznica, Bolnička 65 and 9 other locations
- 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)
- Institute for Onocology and Radiology of Serbia — Belgrade, Pasterova 14, Serbia (RECRUITING)
- General Hospital "Dr Laza K. Lazarevic" Sabac — Šabac, Popa Karana 2-4, Serbia (RECRUITING)
- Health Centre Valjevo — Valjevo, Sinđelićeva 62, Serbia (RECRUITING)
- General Hospital ''Stefan Visoki'' Smederevska Palanka — Smederevska Palanka, Vuka Karadžića 147, Serbia (RECRUITING)
Study contacts
- Study coordinator: Reference Study ID Number: ML46477 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. Only)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Early-stage HER2+ Breast Cancer, Decentralization, Anti-HER2 therapy, Real-world data, Early-stage HER2+ BC