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.

Pfizer

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT04460898

A5481123

Details and patient eligibility

About

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.

Enrollment: 195 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

  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.

     Exclusion Criteria:

• No exclusion criteria will be imposed for the selection of patients.

Trial design

195 participants in 1 patient group

Breast Cancer Patients

Description:

HR+/HER2- metastatic breast cancer patients in the US.