DESTINY BREAST - RESPOND
Research type
Research Study
Full title
A multi-center, multi-country prospective observational study of patients initiating T-DXd in the first or second treatment line for HER2+ unresectable and/or metastatic breast cancer
IRAS ID
326154
Contact name
Anne Armstrong
Contact email
Sponsor organisation
AstraZeneca AB
Duration of Study in the UK
2 years, 7 months, 28 days
Research summary
This is a multi-center, multi-country, observational prospective study that will collect real-world clinical and patient-reported outcome (PRO) and diary data from eligible patients with Human Epidermal Growth Factor Receptor 2 positive (HER2+) (globally) or HER2-low (North America only) in routine clinical practice. Patients eligible for HER2+ cohort include those 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 and for the HER2-low cohort include patients who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
The study is being sponsored by AstraZeneca and is planned to be conducted in several regions including but not limited to North America, Europe, Brazil, Singapore and Israel and aims to enrol approximately 750 eligible patients with HER2+ unresectable and/or 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 (IHC 1+ or IHC 2+/ISH-) 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.REC name
London - Fulham Research Ethics Committee
REC reference
23/PR/0537
Date of REC Opinion
23 Jun 2023
REC opinion
Further Information Favourable Opinion