Real-World Research of Treatment Patterns and Treatment Adherence in Early HER2-positive Breast Cancer in Serbia After Treatment Decentralization (Close2HER)
Status: Recruiting
Location: See all (10) locations...
Study Type: Observational
SUMMARY
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Serbia
Institute for Onocology and Radiology of Serbia
RECRUITING
Belgrade
Healthcare Centre Bor
RECRUITING
Bor
Health Centre Kladovo
RECRUITING
Kladovo
Health Centre Loznica
RECRUITING
Loznica
General Hospital Pančevo
RECRUITING
Pančevo
General Hospital Požarevac
RECRUITING
Požarevac
General Hospital Dr Laza K. Lazarevic Sabac
RECRUITING
Šabac
Health Centre ''Sveti Luka'' Smederevo
RECRUITING
Smederevo
General Hospital ''Stefan Visoki'' Smederevska Palanka
RECRUITING
Smederevska Palanka
Health Centre Valjevo
RECRUITING
Valjevo
Contact Information
Primary
Reference Study ID Number: ML46477 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. Only)
Time Frame
Start Date:2026-02-23
Estimated Completion Date:2028-05-31
Participants
Target number of participants:100
Treatments
Group 1: Cohort A
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.
Group 2: Cohort B
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.
Group 1: Cohort C
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.
Group 1: Cohort D
Participants who missed neoadjuvant therapy and underwent primary BC surgery will start adjuvant treatment at their designated secondary hospital or tertiary center, which is the institution administratively assigned based on their place of residence 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.