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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

258 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-13

Study Completion Date

2022-12-27

Brief Summary

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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)

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Detailed Description

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Conditions

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Breast Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Palbociclib plus an aromatase inhibitor

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

Palbociclib plus an aromatase inhibitor

Intervention Type DRUG

Palbociclib plus an aromatase inhibitor therapy

palbociclib plus fulvestrant

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

Palbociclib plus fulvestrant

Intervention Type DRUG

Palbociclib plus fulvestrant

Interventions

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Palbociclib plus an aromatase inhibitor

Palbociclib plus an aromatase inhibitor therapy

Intervention Type DRUG

Palbociclib plus fulvestrant

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No