RW Treatment Patterns and Outcomes in Postmenopausal HR+/HER2- mBC Patients Treated With Palbociclib Plus Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

195 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-04

Study Completion Date

2019-06-24

Brief Summary

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This is a retrospective, observational study that will document treatment patterns and clinical outcomes of postmenopausal patients diagnosed with HR+/HER2- mBC who received Palbociclib plus Letrozole as initial endocrine-based therapy in US community oncology network settings.

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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- metastatic breast cancer patients in the US.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Diagnosed with locoregional recurrent or metastatic female breast cancer.
2. Pathologically confirmed HR-positive/HER2-negative diagnosis.
3. Received treatment with palbociclib in combination with letrozole as initial endocrine-based therapy for advanced/metastatic breast cancer:

1. Initiated treatment with palbociclib at least 3 months following the provider's first use of palbociclib following its FDA approval.
2. At least 1 month of follow-up (at least one visit with the provider) after initiation of palbociclib.
4. Postmenopausal (or receiving surgical or medical treatment to induce menopause) at the time of initiation of palbociclib.
5. ≥18 year old at initiation of palbociclib.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No