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Clinical Trials in the USA / NCT06495164
Active, not recruiting Observational

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

NCT06495164 · tracked via the Priya Life Science USA tracker
Sponsor
Pfizer
Phase
Observational
Started
2024-06-24
Last updated
2025-11-25

Condition(s) studied

Breast CancerMalignant Neoplasm of Breast

Investigational drug(s) / intervention(s)

Palbociclib →Aromatase inhibitorRibociclib →Abemaciclib →

Palbociclib: CDK4/6 inhibitor

Aromatase inhibitor: Aromatase inhibitor

Ribociclib: CDK4/6 inhibitor

Abemaciclib: CDK4/6 inhibitor

Study 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Overall Survival (OS) — From start of index line of therapy to death, February 2015 - December 2022 or data cutoff

Trial sites (1)

FacilityCityRegionStatus
Pfizer New York New York New York

On this site

📄 Ibrance (palbociclib) drug profile → 📄 Kisqali (ribociclib) drug profile → 📄 Verzenio (abemaciclib) drug profile →

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Other trials for the same condition

Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study Enrolling by invitation
Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer Active, not recruiting
Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009) Recruiting
Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) Active, not recruiting
Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06495164 on ClinicalTrials.gov ↗ ← All trials in the USA