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

NCT05592483

TerminatedN/A

Sponsor: AstraZeneca

Conditions: Breast Cancer

Interventions: None (Observational Study)

Countries: United States, Austria, Brazil, Canada, Israel, Italy, Spain, Switzerland

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (125)

Mobile, Alabama, United States
Chandler, Arizona, United States
Little Rock, Arkansas, United States
Los Angeles, California, United States
Santa Rosa, California, United States
Pensacola, Florida, United States
Atlanta, Georgia, United States
Evergreen Park, Illinois, United States
Glenview, Illinois, United States
Park Ridge, Illinois, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Annapolis, Maryland, United States
Boston, Massachusetts, United States
Southfield, Michigan, United States
Saint Paul, Minnesota, United States
Kansas City, Missouri, United States
Camden, New Jersey, United States
Florham Park, New Jersey, United States
Jamaica, New York, United States
Lake Success, New York, United States
Eugene, Oregon, United States
York, Pennsylvania, United States
Greenville, South Carolina, United States
Germantown, Tennessee, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Dallas, Texas, United States
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