An Observational Study of Patients Receiving T-DXd for Treatment of HER2+, and HER2-low Unresectable and/or Metastatic Breast Cancer

Study Overview
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Brief Summary
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This study will collect real-world clinical and patient reported outcomes (PRO) and diary data from eligible patients with documented Human Epidermal Growth Factor Receptor 2 (HER2+) [globally] or HER2-low [North America only] in routine clinical practice.

Detailed Description
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This is a multi-center, observational prospective study that will characterize the demographic and clinical characteristics, treatment patterns, effectiveness, tolerability and its management, and patient experience of Trastuzumab Deruxtecan (T-DXd) in a real-world setting. This study is planned to be conducted in several countries and aims to enroll approximately 750 patients eligible patients with HER2+ unresectable and/or metastatic breast cancer (mBC) who has received a prior anti HER2 based regimen in the metastatic setting or in the neoadjuvant or adjuvant setting and has developed disease recurrence during or within 6 months of completing therapy. Approximately 250 eligible patients with HER2-low unresectable and/or mBC who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy will be enrolled into the study in North America only. The planned duration of patient recruitment is approximately 18 months for HER2+ and approximately 12 months for HER2 low.

Official Title
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A Multi-center, Multi-country Prospective Observational Study of Patients Initiating T-DXd in the First or Second Treatment Line for HER2+, and HER2-low Unresectable and/or Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: None (Observational Study)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥18 years of age at time of consent. Histological or cytological confirmed diagnosis of unresectable and/or mBC. Documented HER2 status via a validated method. Adult patients with unresectable or metastatic HER2+ breast cancer who have received a prior anti-HER2-based regimen in the metastatic setting or in the neoadjuvant or adjuvant setting and developed disease recurrence during or within 6 months of completing therapy. Or Adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. Decision to newly initiate monotherapy T-DXd per standard of care. Capable of providing informed consent and completing questionnaires. Exclusion Criteria: Pregnancy or breastfeeding. History of other primary malignancies in 2 years prior to unresectable and/or mBC diagnosis. Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 130 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HER2+ Cohort<br>Patients with HER2+ unresectable and/or mBC who are prescribed T-DXd and have received a prior anti-HER2 based regimen. | Other: None (Observational Study)<br>* Not Applicable since observational study<br>* Other names: Observational study;|
| HER2-low cohort<br>Patients with HER2-low unresectable and/or mBC who are prescribed T-DXd and have received a prior chemotherapy. | Other: None (Observational Study)<br>* Not Applicable since observational study<br>* Other names: Observational study;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real-World Time to Next Treatment (rwTTNT) | Real-world time to next treatment will be evaluated. rwTTNT is defined as the length of time from date of first T-Dxd administration to the date the patient received an administration of their next systemic treatment regimen or to their date of death if there is a death prior to having another systemic treatment regimen. | From first dose of T-DXd until study discontinuation (approximately 3 years) | 
| T-Dxd treatment patterns for HER2+ cohort | Treatment patterns will be summarised using summary statistics. | Approximately 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T-Dxd treatment patterns for HER2-low | Treatment patterns will be summarised using summary statistics. | Approximately 3 years | 
| Demographics and clinical charcteristics | Summary statistics will be used to describe the Demographics and clinical characteristics | At Baseline (14 to 30 days prior to T-DXd initiation) | 
| Number of patients with Physician reported Safety Events of Interest (SEIs) | The safety and tolerability of T-Dxd through the collection of physician-reported SEIs will be assessed. | From first dose of T-DXd until End of T-DXd treatment (40 + 7 days after last T-DXd administration) | 
| Number of patients provided prophylactic and reactive treatment for SEIs management | The management of SEIs will be characterized. | From first dose of T-DXd until End of T-DXd treatment (40 + 7 days after last T-DXd administration) | 
| Real-World Time to Discontinuation (rwTTD) | Real-World Time to Discontinuation of T-DXd will be evaluated. rwTTD is defined as time from index date to the earliest date of T-DXd discontinuation, or death. | From first dose of T-DXd until study discontinuation (approximately 3 years) | 
| Patient-reported overall side effect burden as measured by the Patient's Global Impression of Treatment Tolerability (PGI-TT) | Patient-reported tolerability will be evaluated by PGI-TT. Single question asking patients how bothered they were by the side effects of their cancer treatment, ranging from Not at all to Very much. | Approximately 3 years | 
| Symptomatic SEI as measured by selected items from National Cancer Institute Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE) | Patient-reported tolerability will be evaluated by selected items from the NCI PRO-CTCAE. The following items are selected: nausea, vomiting, bloating of the abdomen, shortness of breath, cough, heart palpitations, hair loss, and fatigue, tiredness or lack of energy. | Approximately 3 years | 
| Daily Nausea and Vomiting symptom diary | Nausea and vomiting symptoms diary will be assessed based on severity, interference with appetite and usual activities. | From first dose of T-DXd until 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Real-World Evidence, Unresectable Breast Cancer, Metastatic Breast Cancer, HER2+, HER2-low, Observational, non-interventional