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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment Adherence Rate | Up to 2.25 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: ML46477 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 (U.S. Only) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Centre Loznica | Recruiting | Loznica | Bolnička 65 | 15300 | Serbia | |
| General Hospital Požarevac |
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| Label | URL |
|---|---|
| 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. | View source |
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| 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 |
| Recruiting |
| Požarevac |
| Bratstva Jedinstva 135 |
| 12000 |
| Serbia |
| Healthcare Centre Bor | Recruiting | Bor | Dragiše Mišovića 1 | 19210 | Serbia |
| Health Centre Kladovo | Recruiting | Kladovo | Dunavska 1-3 | 19320 | Serbia |
| Health Centre ''Sveti Luka'' Smederevo | Recruiting | Smederevo | Knez Mihailova 51 | 11300 | Serbia |
| General Hospital Pančevo | Recruiting | Pančevo | Miloša Trebinjca 11 | 26000 | Serbia |
| Institute for Onocology and Radiology of Serbia | Recruiting | Belgrade | Pasterova 14 | 11000 | Serbia |
| General Hospital "Dr Laza K. Lazarevic" Sabac | Recruiting | Šabac | Popa Karana 2-4 | 15000 | Serbia |
| Health Centre Valjevo | Recruiting | Valjevo | Sinđelićeva 62 | 14000 | Serbia |
| General Hospital ''Stefan Visoki'' Smederevska Palanka | Recruiting | Smederevska Palanka | Vuka Karadžića 147 | 11420 | Serbia |