Early-stage HER2+ Breast CancerClose2HERNCT07527741
A Study to Assess Treatment Patterns and Treatment Adherence in Early HER2-positive Breast Cancer Participants After Treatment Decentralization
An observational study of Early-stage HER2+ Breast Cancer, run by Hoffmann-La Roche at 10 sites in Serbia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early-stage HER2+ Breast Cancer
- How many people
- 100 participants
- Where
- 10 sitesSerbia
- Study dates
- 23 Feb 2026to 31 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: ML46477 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
10 sites in 1 country
Serbia10 sites, 10 recruiting
- Recruiting
Institute for Onocology and Radiology of Serbia
Belgrade, Pasterova 14, 11000
- Recruiting
Healthcare Centre Bor
Bor, Dragiše Mišovića 1, 19210
- Recruiting
Health Centre Kladovo
Kladovo, Dunavska 1-3, 19320
- Recruiting
Health Centre Loznica
Loznica, Bolnička 65, 15300
- Recruiting
General Hospital Pančevo
Pančevo, Miloša Trebinjca 11, 26000
- Recruiting
General Hospital Požarevac
Požarevac, Bratstva Jedinstva 135, 12000
- Recruiting
General Hospital "Dr Laza K. Lazarevic" Sabac
Šabac, Popa Karana 2-4, 15000
- Recruiting
Health Centre ''Sveti Luka'' Smederevo
Smederevo, Knez Mihailova 51, 11300
- Recruiting
General Hospital ''Stefan Visoki'' Smederevska Palanka
Smederevska Palanka, Vuka Karadžića 147, 11420
- Recruiting
Health Centre Valjevo
Valjevo, Sinđelićeva 62, 14000
About this study
Official title: 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.
- Conditions
- Early-stage HER2+ Breast Cancer
- Keywords
- Decentralization, Anti-HER2 therapy, Real-world data, Early-stage HER2+ BC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Treatment Adherence Rate
Measured: Up to 2.25 years
Secondary outcomes (12)
Treatment Completion Rate for Anti-HER2 Treatment
Measured: Up to 2.25 years
Percentage of Participants With ≥1 Dose Delays Exceeding a Pre-defined Threshold (3 Weeks) From the Scheduled Date
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Baseline
Time to Adjuvant Treatment Initiation
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start23 Feb 2026
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-stage HER2+ Breast CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527741
- Sponsor's protocol ID
- ML46477
- Acronym
- Close2HER
- Status last verified
- Nov 2026
- First submitted
- 7 Apr 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Research of Treatment Patterns and Treatment Adherence in Early HER2-positive Breast Cancer in Serbia After Treatment Decentralization (Close2HER)
- ClinicalTrials.gov ID
- NCT07527741
- Acronym / sponsor ID
- Close2HER / ML46477
- Conditions
- Early-stage HER2+ Breast Cancer
- Keywords
- Decentralization, Anti-HER2 therapy, Real-world data, Early-stage HER2+ BC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment Adherence Rate
Time frame: Up to 2.25 years
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reference Study ID Number: ML46477 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
Clinical Trials study director
Hoffmann-La Roche
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early-stage HER2+ Breast Cancer, run by Hoffmann-La Roche at 10 sites in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reference Study ID Number: ML46477 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. Only), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Adherence Rate (time frame: Up to 2.25 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.