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NCT Number: NCT06495164

A Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer

Palbociclib, the first oral CDK4/6 inhibitor, is an approved medicine indicated for the treatment of a kind of advanced/metastatic breast cancer (MBC), called hormone receptors positive (HR+)/ Human epidermal growth factor receptor 2 negative (HER2-) disease. Palbociclib is given orally in combination with hormonal therapies.

The purpose of this study is to better understand how Palbociclib combination is used in real-life conditions and its clinical impact compared with hormonal therapy. The study will also evaluate how long patients take the different CDK 4/6 inhibitor drugs and whether using those drugs impacts the use of chemotherapy later.

Male and female patients aged 18 years old or more presenting the following conditions will be selected for the study:

* HR+/HER2- MBC * First treatment with Palbociclib, hormonal therapy, or other CDK4/6 inhibitors after MBC diagnosis The study will use data without personal identity, which were obtained from medical records in routine clinical practice.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Malignant Neoplasm of Breast Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer New York

New York, 10001, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patients are eligible for the study if they were 18 years of age or older at MBC diagnosis, had HR+/HER2- confirmed and initiated first line therapy (CDK4/6i, ET, CT, or other) in the metastatic setting during the period from February 2015 through June 2022 or data cutoff.

Treatment and study plan

Palbociclib

Drug

CDK4/6 inhibitor

Other names: Ibrance

Aromatase Inhibitor

Drug

Aromatase inhibitor

Other names: a class of drugs included in the study: letrozole (Femara), anastrozole (Arimidex), and exemestane (Aromasin)

Ribociclib

Drug

CDK4/6 inhibitor

Other names: Kisqali

Abemaciclib

Drug

CDK4/6 inhibitor

Other names: Verzenio

Primary outcomes

  1. Overall Survival (OS)

    Time frame: From start of index line of therapy to death, February 2015 - December 2022 or data cutoff

Secondary outcomes

  1. Real Progression Free Survival (rwPFS)

    Time frame: From start of index line of therapy to death or disease progression, February 2015 - December 2022 or data cutoff

  2. Progression Free Survival 2

    Time frame: from start of index treatment to disease progression on the 2nd line of therapy or death, February 2015 - December 2022 or data cutoff

  3. Real-World Tumor Response (rwTR)

    Time frame: From start of index treatment to tumor response, February 2015 - December 2022 or data cutoff

  4. Duration of treatment

    Time frame: from index treatment initiation to end of the treatment, February 2015 - December 2022 or data cutoff

  5. Time to chemotherapy

    Time frame: from index treatment initiation to subsequent chemotherapy, February 2015 - December 2022 or data cutoff

Other outcomes

  1. Early discontinuation

    Time frame: from index treatment initiation to discontinuation between February 2015 - December 2022 or data cutoff

  2. Dose adjustment

    Time frame: from index treatment initiation to initial dose change, February 2015 - December 2022 or data cutoff

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Palbociclib Treatment Patterns and Outcomes in HR+/HER2- MBC: Flatiron Database Analysis

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2024
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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