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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

975 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-18

Study Completion Date

2020-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Breast Cancer Patients

HR + /HER2- Advanced/Metastatic Breast Cancer patients in U.S.A

No interventions assigned to this group

Eligibility Criteria

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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).