Early-stage HER2+ Breast Cancer
Conditions
Keywords
Decentralization, Anti-HER2 therapy, Real-world data, Early-stage HER2+ BC
Brief 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). 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.
Interventions
None listed
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment Adherence Rate | Up to 2.25 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Cohort B: Change in Intra-participant Travel Burden Between the Neoadjuvant and Adjuvant Treatment Centers | 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. |
| 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 | 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). |
| Mean Intra-patient Change in the EORTC QLQ-C30 GHS/QoL Score | 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. |
| Time to Neoadjuvant Treatment Initiation | 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. |
| Time to Surgery | 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. |
| 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 | At Baseline | Data for neoadjuvant treatment will be collected retrospectively at the baseline visit using the participant's medical records. |
| Percentage of Participants Not Treated With Neoadjuvant Therapy | At Baseline | Data for neoadjuvant treatment will be collected retrospectively at the baseline visit using the participant's medical records. |
| Percentage of Participants With pCR After Neoadjuvant Systemic Therapy Completion | At Baseline | Data for neoadjuvant treatment will be collected retrospectively at the baseline visit using the participant's medical records. |
Countries
Serbia
Contacts
CONTACTReference Study ID Number: ML46477 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed