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

Stopped early

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT05592483

Run by

AstraZeneca

People needed

78

Starts

2023-07-07

Expected to finish

2024-05-29

Last updated by the study team

2024-11-07

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Research Site — Lexington, Kentucky, United States
• Research Site — Louisville, Kentucky, United States
• Research Site — Annapolis, Maryland, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Southfield, Michigan, United States
• Research Site — Saint Paul, Minnesota, United States
• Research Site — Kansas City, Missouri, United States
• Research Site — Camden, New Jersey, United States
• Research Site — Florham Park, New Jersey, United States
• Research Site — Jamaica, New York, United States
• Research Site — Lake Success, New York, United States
• Research Site — Eugene, Oregon, United States
• Research Site — York, Pennsylvania, United States
• Research Site — Greenville, South Carolina, United States
• Research Site — Germantown, Tennessee, United States
• Research Site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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