A Study to Assess Treatment Patterns and Treatment Adherence in Early HER2-positive Breast Cancer Participants After Treatment Decentralization (Close2HER)

Real-World Research of Treatment Patterns and Treatment Adherence in Early HER2-positive Breast Cancer in Serbia After Treatment Decentralization (Close2HER)

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.

Study Overview

• Status: Recruiting
• Conditions: Early-stage HER2+ Breast Cancer

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: ML46477 https://forpatients.roche.com/; Phone Number: 888-662-6728 (U.S. Only); Email: global-roche-genentech-trials@gene.com
• Study Contact Backup: Name: Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Study Locations

• Serbia
  • Bolnička 65
    • Loznica, Bolnička 65, Serbia, 15300
      • Recruiting
      • Health Centre Loznica
  • Bratstva Jedinstva 135
    • Požarevac, Bratstva Jedinstva 135, Serbia, 12000
      • Recruiting
      • General Hospital Požarevac
  • Dragiše Mišovića 1
    • Bor, Dragiše Mišovića 1, Serbia, 19210
      • Recruiting
      • Healthcare Centre Bor
  • Dunavska 1-3
    • Kladovo, Dunavska 1-3, Serbia, 19320
      • Recruiting
      • Health Centre Kladovo
  • Knez Mihailova 51
    • Smederevo, Knez Mihailova 51, Serbia, 11300
      • Recruiting
      • Health Centre ''Sveti Luka'' Smederevo
  • Miloša Trebinjca 11
    • Pančevo, Miloša Trebinjca 11, Serbia, 26000
      • Recruiting
      • General Hospital Pancevo
  • Pasterova 14
    • Belgrade, Pasterova 14, Serbia, 11000
      • Recruiting
      • Institute for Onocology and Radiology of Serbia
  • Popa Karana 2-4
    • Šabac, Popa Karana 2-4, Serbia, 15000
      • Recruiting
      • General Hospital "Dr Laza K. Lazarevic" Sabac
  • Sinđelićeva 62
    • Valjevo, Sinđelićeva 62, Serbia, 14000
      • Recruiting
      • Health Centre Valjevo
  • Vuka Karadžića 147
    • Smederevska Palanka, Vuka Karadžića 147, Serbia, 11420
      • Recruiting
      • General Hospital ''Stefan Visoki'' Smederevska Palanka

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of participants diagnosed with HER2-positive eBC who are initiating or undergoing treatment following a nationwide healthcare policy change in Serbia that decentralized the administration of anti-HER2 therapies.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Treatment Adherence Rate	Up to 2.25 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Completion Rate for Anti-HER2 Treatment		Up to 2.25 years
Percentage of Participants With ≥1 Dose Delays Exceeding a Pre-defined Threshold (3 Weeks) From the Scheduled Date		Up to 2.25 years
Mean Travel Burden Between Group 1 (Cohorts A, C, D) and Group 2 (Cohort B) During the Adjuvant Therapy Phase	Travel Burden is a composite measure encompassing both objective and subjective components. Objective travel burden is defined by the one-way travel distance (in kilometers [km]) and one-way travel time (in minutes) from the participant's residence to the treatment center. Subjective travel burden will capture the participant's personal experience and will be assessed using patient-reported outcomes collected via dedicated questionnaires.	Up to 2.25 years
Cohort B: Change in Intra-participant Travel Burden Between the Neoadjuvant and Adjuvant Treatment Centers	Travel Burden is a composite measure encompassing both objective and subjective metrices. Objective travel metrics include driving distance and travel time and subjective, patient-reported metrics include out-of-pocket costs, mode of transport, and perceived travel-related challenges. Intra-participant travel burden between the Neoadjuvant and Adjuvant treatment centers will be done as a longitudinal analysis of the change in these metrics from the neoadjuvant to the adjuvant phase.	Up to 2.25 years
Difference in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/QoL Score, Between Participants of Cohort B and Cohort C	EORTC QLQ-C30 is a cancer-specific instrument consisting of 30 questions that evaluates 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea & vomiting, & pain), GHS/QoL & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties). The GHS/QoL questions will be scored on a 7-point scale, with scores ranging from 1=Very poor to 7=Excellent. Scores will be linearly transformed to a range of 0-100. A high score for a GHS/QoL scale indicates a better health-related quality of life (HRQoL).	At 6 months post-baseline
Mean Intra-patient Change in the EORTC QLQ-C30 GHS/QoL Score	EORTC QLQ-C30 is a cancer-specific instrument consisting of 30 questions that evaluates 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea & vomiting, & pain), GHS/QoL & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties). The GHS/QoL questions will be scored on a 7-point scale, with scores ranging from 1=Very poor to 7=Excellent. Scores will be linearly transformed to a range of 0-100. A high score for a GHS/QoL scale indicates a better HRQoL.	Cohorts A, B and C: Baseline to Month 6; Cohort D: Month 6 to Month 12
Time to Neoadjuvant Treatment Initiation	Time to Neoadjuvant Treatment Initiation was defined as time from early breast cancer (eBC) diagnosis to the start of neoadjuvant treatment. Data for neoadjuvant treatment will be collected retrospectively at the baseline visit using the participant's medical records.	At Baseline
Time to Surgery	Time to surgery was defined as the time from the neoadjuvant treatment completion to surgery. Data for neoadjuvant treatment will be collected retrospectively at the baseline visit using the participant's medical records.	At Baseline
Time to Adjuvant Treatment Initiation		Time from surgery to the start of adjuvant treatment (up to approximately 1.25 years)
Percentage of Participants Treated at Least Once With Neoadjuvant Therapy	Data for neoadjuvant treatment will be collected retrospectively at the baseline visit using the participant's medical records.	At Baseline
Percentage of Participants Not Treated With Neoadjuvant Therapy	Data for neoadjuvant treatment will be collected retrospectively at the baseline visit using the participant's medical records.	At Baseline
Percentage of Participants With pCR After Neoadjuvant Systemic Therapy Completion	Data for neoadjuvant treatment will be collected retrospectively at the baseline visit using the participant's medical records.	At Baseline

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

Helpful Links

• Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Real-world data; Anti-HER2 therapy; Decentralization; Early-stage HER2+ BC
• Other Study ID Numbers: ML46477

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No