Treatment Patterns and Clinical Outcomes Among Patients Receiving Palbociclib Combinations for Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2 ) Advanced/Metastatic Breast Cancer in the Arabian Gulf Region

Pfizer

Status: Completed

Conditions: Breast Neoplasms

Treatments: Drug: Palbociclib plus an aromatase inhibitor; Drug: Palbociclib plus fulvestrant

Study type: Observational

Funder types: Industry

Identifiers

NCT04916509

TREASURE

A5481136

Details and patient eligibility

About

retrospective non-interventional study (NIS) that aims to describe the demographics, clinical characteristics, clinical outcomes, and treatment patterns, among patients receiving palbociclib for the treatment of HR+/HER2- metastatic/locally advanced breast cancer (BC)

Enrollment: 258 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years old.
2. HR+/HER2- BC diagnosis with confirmed metastatic/locally advanced disease.
3. Patient initiated on palbociclib (regardless the line of therapy) within the period between 01st January 2015 and 01st March 2019.
4. Minimum of six months of follow up data since palbociclib initiation.
5. Received palbociclib plus aromatase inhibitor or palbociclib plus fulvestrant in line with the licensed indication(s).

Exclusion criteria

1. Prior or current enrolment in an interventional clinical trial for metastatic/locally advanced BC.
2. Patients who were initiated on palbociclib after 01st March 2019.

Trial design

258 participants in 2 patient groups

Palbociclib plus an aromatase inhibitor

Description:

Adult metastatic breast cancer patients who initiated Palbociclib + an aromatase inhibitor. Data will be retrospectively abstracted over an observational look-back period from 01st January 2015 to 30th September 2019. Aligned with Locally Approved Indication

Treatment:

Drug: Palbociclib plus an aromatase inhibitor

palbociclib plus fulvestrant

Description:

Adult metastatic breast cancer patients who initiated Palbociclib + fulvestrant. Data will be retrospectively abstracted over an observational look-back period from 01st January 2015 to 30th September 2019. Aligned with Locally Approved Indication

Treatment:

Drug: Palbociclib plus fulvestrant