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A Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer
NCT06495164 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- DRUG Palbociclib
- DRUG Abemaciclib
- DRUG Ribociclib
- DRUG Aromatase inhibitor
Study Locations (1)
New York
- Pfizer New York — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2024-06-24 |
| Est. Completion | 2026-12-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06495164
The ClinicalTrials.gov registry entry for NCT06495164 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions — of which Palbociclib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06495164 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06495164 about?
NCT06495164 is a clinical study titled "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 combinati...
What is the current status of trial NCT06495164?
This trial is currently active not recruiting. The enrollment target is 1 participants. The study started on 2024-06-24. Estimated completion is 2026-12-30.
What conditions does trial NCT06495164 study?
This clinical trial studies the following conditions: Breast Cancer, Malignant Neoplasm of Breast. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06495164?
The interventions under investigation include: Palbociclib (DRUG), Abemaciclib (DRUG), Ribociclib (DRUG), Aromatase inhibitor (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06495164?
This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06495164 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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