Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07527741

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Early-stage HER2+ Breast Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Health Centre Loznica, Loznica, Bolnička 65, Serbia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Treatment Adherence Rate

    Time frame: Up to 2.25 years

Secondary outcomes

  1. Treatment Completion Rate for Anti-HER2 Treatment

    Time frame: Up to 2.25 years

  2. 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

  3. 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

    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.

  4. Cohort B: Change in Intra-participant Travel Burden Between the Neoadjuvant and Adjuvant Treatment Centers

    Time frame: Up to 2.25 years

    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.

  5. 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

    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).

  6. 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

    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.

  7. Time to Neoadjuvant Treatment Initiation

    Time frame: At Baseline

    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.

  8. Time to Surgery

    Time frame: At Baseline

    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.

  9. Time to Adjuvant Treatment Initiation

    Time frame: Time from surgery to the start of adjuvant treatment (up to approximately 1.25 years)

  10. Percentage of Participants Treated at Least Once With Neoadjuvant Therapy

    Time frame: At Baseline

    Data for neoadjuvant treatment will be collected retrospectively at the baseline visit using the participant's medical records.

  11. Percentage of Participants Not Treated With Neoadjuvant Therapy

    Time frame: At Baseline

    Data for neoadjuvant treatment will be collected retrospectively at the baseline visit using the participant's medical records.

  12. Percentage of Participants With pCR After Neoadjuvant Systemic Therapy Completion

    Time frame: At Baseline

    Data for neoadjuvant treatment will be collected retrospectively at the baseline visit using the participant's medical records.

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Reference Study ID Number: ML46477 https://forpatients.roche.com/ No attachments to email below.

CONTACT

[email protected]

888-662-6728 (U.S. Only)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Acronym: Close2HER

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 14, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.