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HR+/ HER2- Advanced/ Metastatic Breast Cancer Real World Treatment Patterns and Outcomes

TerminatedN/A

Sponsor: Pfizer

Conditions: Breast Cancer

Countries: United States

This is a retrospective, observational study that will document the treatment patterns and clinical outcomes of patients diagnosed with HR+/HER2- A/MBC who received CDK4/6i combination therapy with aromatase inhibitors (AI) as the initial endocrine-based therapy in the A/MBC setting.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

1. Female or male sex.
2. Diagnosis (confirmed by clinical review) of A/MBC, defined as breast cancer at stage IIIB, stage IIIC, stage IV or identified as having distant metastasis.
3. Age ≥18 years at A/MBC diagnosis.
4. Initiated a CDK4/6i in combination with an AI as initial endocrine-based therapy after A/MBC diagnosis on or after 2/3/2015 and before 4/1/2019.

   •Note that the date of the start of the inclusion period reflects the month that the first CDK4/6i (ie, Palbociclib) received U.S. FDA approval.
5. Evidence of ER or PR positive disease, or absence of any indication of ER and PR negative disease closest to A/MBC diagnosis (ie, patients are eligible without affirmative indication of ER/PR+ status as long as ER/PR- indication is not present).
6. Evidence of HER2 negative disease, or absence of any indication of HER2 positive disease closest to A/MBC diagnosis (ie, patients are eligible without affirmative indication of HER2- status as long as HER2+ indication is not present).

Exclusion Criteria:

1\. Enrollment in an interventional clinical trial for A/MBC during the study observation period.

Locations (1)

New York, New York, United States