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Recruiting NCT07527741

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

— Observational Early-stage HER2+ Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Early-stage HER2+ Breast Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Serbia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • Treatment Adherence Rate [Time frame: Up to 2.25 years]
Secondary outcome measures (12)
  • Treatment Completion Rate for Anti-HER2 Treatment [Time frame: Up to 2.25 years]
  • Percentage of Participants With ≥1 Dose Delays Exceeding a Pre-defined Threshold (3 Weeks) From the Scheduled Date [Time frame: 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 [Time frame: Up to 2.25 years]
  • Cohort B: Change in Intra-participant Travel Burden Between the Neoadjuvant and Adjuvant Treatment Centers [Time frame: 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 [Time frame: At 6 months post-baseline]
  • Mean Intra-patient Change in the EORTC QLQ-C30 GHS/QoL Score [Time frame: Cohorts A, B and C: Baseline to Month 6; Cohort D: Month 6 to Month 12]
  • Time to Neoadjuvant Treatment Initiation [Time frame: At Baseline]
  • Time to Surgery [Time frame: At Baseline]
  • Time to Adjuvant Treatment Initiation [Time frame: 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 [Time frame: At Baseline]
  • Percentage of Participants Not Treated With Neoadjuvant Therapy [Time frame: At Baseline]
  • Percentage of Participants With pCR After Neoadjuvant Systemic Therapy Completion [Time frame: At Baseline]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Serbia · 10 centers
  • Health Centre Loznica — Loznica
  • General Hospital Požarevac — Požarevac
  • Healthcare Centre Bor — Bor
  • Health Centre Kladovo — Kladovo
  • Health Centre ''Sveti Luka'' Smederevo — Smederevo
  • General Hospital Pančevo — Pančevo
  • Institute for Onocology and Radiology of Serbia — Belgrade
  • General Hospital "Dr Laza K. Lazarevic" Sabac — Šabac
  • … and 2 more centers

Identifiers

NCT: NCT07527741 · ML46477

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗