Clinical trial · Observational
A Study to Assess Treatment Patterns and Treatment Adherence in Early HER2-positive Breast Cancer Participants After Treatment Decentralization
Real-World Research of Treatment Patterns and Treatment Adherence in Early HER2-positive Breast Cancer in Serbia After Treatment Decentralization (Close2HER)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early-stage HER2+ Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (4)
- label
- Group 1: Cohort A
- description
- Participants who received neoadjuvant therapy and achieved pathological complete response (pCR) and receive their adjuvant treatment at a designated secondary or tertiary center, administratively assigned based on their place of residence will be observed to assess the impact on quality of life (QoL) and travel burden. All treatment decisions will be made at the discretion of the treating physician and participant, reflecting routine clinical practice without any study-mandated interventions.
- label
- Group 2: Cohort B
- description
- Participants who received neoadjuvant therapy at a secondary center and were subsequently found to have residual invasive disease will be referred to a centralized referent tertiary institution to receive their adjuvant treatment and will be observed to assess the impact on QoL and travel burden. All treatment decisions will be made at the discretion of the treating physician and participant, reflecting routine clinical practice without any study-mandated interventions.
- label
- Group 1: Cohort C
- description
- Participants who received neoadjuvant therapy at their designated tertiary center, which is the institution administratively assigned based on their place of residence, and subsequently found to have residual invasive disease will continue with adjuvant treatment at the same institution, and will be observed to assess the impact on QoL and travel burden. All treatment decisions will be made at the discretion of the treating physician and participant, reflecting routine clinical practice without any study-mandated interventions.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available