An Observational Study of Patients Receiving T-DXd for Treatment of HER2+, and HER2-low Unresectable and/or Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Other: None (Observational Study)
- Registration Number
- NCT05592483
- Lead Sponsor
- AstraZeneca
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 78
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HER2+ Cohort None (Observational Study) Patients with HER2+ unresectable and/or mBC who are prescribed T-DXd and have received a prior anti-HER2 based regimen. HER2-low cohort None (Observational Study) Patients with HER2-low unresectable and/or mBC who are prescribed T-DXd and have received a prior chemotherapy.
- Primary Outcome Measures
Name Time Method Real-World Time to Next Treatment (rwTTNT) From first dose of T-DXd until study discontinuation (approximately 3 years) 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.
T-Dxd treatment patterns for HER2+ cohort Approximately 3 years Treatment patterns will be summarised using summary statistics.
- Secondary Outcome Measures
Name Time Method Demographics and clinical charcteristics At Baseline (14 to 30 days prior to T-DXd initiation) Summary statistics will be used to describe the Demographics and clinical characteristics
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) Approximately 3 years 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.
Daily Nausea and Vomiting symptom diary From first dose of T-DXd until 3 months Nausea and vomiting symptoms diary will be assessed based on severity, interference with appetite and usual activities.
T-Dxd treatment patterns for HER2-low Approximately 3 years Treatment patterns will be summarised using summary statistics.
Number of patients with Physician reported Safety Events of Interest (SEIs) From first dose of T-DXd until End of T-DXd treatment (40 + 7 days after last T-DXd administration) The safety and tolerability of T-Dxd through the collection of physician-reported SEIs will be assessed.
Number of patients provided prophylactic and reactive treatment for SEIs management From first dose of T-DXd until End of T-DXd treatment (40 + 7 days after last T-DXd administration) The management of SEIs will be characterized.
Patient-reported overall side effect burden as measured by the Patient's Global Impression of Treatment Tolerability (PGI-TT) Approximately 3 years 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.
Real-World Time to Discontinuation (rwTTD) From first dose of T-DXd until study discontinuation (approximately 3 years) 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.
Trial Locations
- Locations (1)
Research Site
🇬🇧Manchester, United Kingdom