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.
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.
Study Type
OBSERVATIONAL
Enrollment
78
Not Applicable since observational study
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.
Time frame: 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.
Time frame: Approximately 3 years
T-Dxd treatment patterns for HER2-low
Treatment patterns will be summarised using summary statistics.
Time frame: Approximately 3 years
Demographics and clinical charcteristics
Summary statistics will be used to describe the Demographics and clinical characteristics
Time frame: 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.
Time frame: 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.
Time frame: From first dose of T-DXd until End of T-DXd treatment (40 + 7 days after last T-DXd administration)
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Research Site
Mobile, Alabama, United States
Research Site
Chandler, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Los Angeles, California, United States
Research Site
Santa Rosa, California, United States
Research Site
Pensacola, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Evergreen Park, Illinois, United States
Research Site
Glenview, Illinois, United States
Research Site
Park Ridge, Illinois, United States
...and 115 more locations
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From first dose of T-DXd until 3 months