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

AstraZeneca

Status: Terminated

Conditions: Breast Cancer

Treatments: Other: None (Observational Study)

Study type: Observational

Funder types: Industry

Identifiers

NCT05592483

D9673R00025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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.

Trial design

78 participants in 2 patient groups

HER2+ Cohort

Description:

Patients with HER2+ unresectable and/or mBC who are prescribed T-DXd and have received a prior anti-HER2 based regimen.

Treatment:

Other: None (Observational Study)

HER2-low cohort

Description:

Patients with HER2-low unresectable and/or mBC who are prescribed T-DXd and have received a prior chemotherapy.

Treatment:

Other: None (Observational Study)