Clinical Trial Radar

Name: Palbociclib Treatment Patterns and Outcomes in HR+/HER2- MBC: Flatiron Database Analysis
Creator: Pfizer
Published: 2024-07-10
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

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	Clinical Trial NCT06495164 for Breast Cancer, Malignant Neoplasm of Breast is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.

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A Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer 1

Active, not recruiting

Clinical Trial NCT06495164 is an observational study for Breast Cancer, Malignant Neoplasm of Breast that is active, not recruiting. It started on June 24, 2024 with plans to enroll 1 participants. Led by Pfizer, it is expected to complete by December 30, 2026. The latest data from ClinicalTrials.gov was last updated on November 25, 2025.

Brief Summary

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 re...

Official Title

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

Conditions

Breast CancerMalignant Neoplasm of Breast

Publications

Brufsky A, Layman RM, Liu X, Li B, McRoy L, Cohen AB, Estevez M, Cottu P, Curigliano G, Rugo HS. Real-world effectiveness of palbociclib in combination with an aromatase inhibitor in HR+/HER2- bone-only metastatic breast cancer. Breast. 2026 Feb 24;86:104744. doi: 10.1016/j.breast.2026.104744....

Other Study IDs

A5481189
NCT06495164 (Registry Identifier) (ClinicalTrials.gov)

NCT ID Number

NCT06495164

Start Date (Actual)

2024-06-24

Last Update Posted

2025-11-25

Completion Date (Estimated)

2026-12-30

Enrollment (Estimated)

Study Type

Observational

Status

Active, not recruiting

Keywords

Metastatic breast cancer
CDK4/6 inhibitor
Real-world data
Retrospective observational study
Palbociclib
Overall survival

Arms / Interventions

Participant Group/Arm	Intervention/Treatment
Palbociclib + aromatase inhibitor (AI) Oral palbociclib + AI combination treatment regimen as decided by physician	Palbociclib CDK4/6 inhibitor Aromatase inhibitor Aromatase inhibitor
Aromatase inhibitor (AI) Oral AI treatment regimen as decided by physician	Aromatase inhibitor Aromatase inhibitor
Abemaciclib plus aromatase inhibitor (AI) Oral abemaciclib plus AI treatment regimen as decided by physician	Palbociclib CDK4/6 inhibitor Aromatase inhibitor Aromatase inhibitor Abemaciclib CDK4/6 inhibitor
Ribociclib plus aromatase inhibitor (AI) Oral ribociclib plus AI as decided by physician	Aromatase inhibitor Aromatase inhibitor Ribociclib CDK4/6 inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)		From start of index line of therapy to death, February 2015 - December 2022 or data cutoff

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Real Progression Free Survival (rwPFS)		From start of index line of therapy to death or disease progression, February 2015 - December 2022 or data cutoff
Progression Free Survival 2		from start of index treatment to disease progression on the 2nd line of therapy or death, February 2015 - December 2022 or data cutoff
Real-World Tumor Response (rwTR)		From start of index treatment to tumor response, February 2015 - December 2022 or data cutoff
Duration of treatment		from index treatment initiation to end of the treatment, February 2015 - December 2022 or data cutoff
Time to chemotherapy		from index treatment initiation to subsequent chemotherapy, February 2015 - December 2022 or data cutoff

Participation Assistant

Eligibility Criteria

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.

Pfizer

No contact data.

1 Study Locations in 1 Countries

United States

New York

Pfizer New York, New York, New York, 10001, United States