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Completed

NCT Number: NCT06962969

A Study to Understand the Patients Confirmed to Have Advanced or Metastatic Breast Cancer and Receiving Palbociclib Treatment Using a Real-world Database

The purpose of this real-world study is to look at breast cancer patients receiving Palbociclib using a large real-world database collected under real-world practice. This study also looks at the safety of Ibrance, including any side effects. Side effects are undesired effects of a medicine or other type of treatment.

This study will include the data of the following participants:

* Adult women (more than18 years of age) with at least one visit with a breast cancer * Patients with locally advanced breast cancer or metastatic breast cancer with a staging classification of stage III, stage IV. Advanced cancer is a term that is often used to describe cancer that is unlikely to be cured. Metastatic cancer is the cancer which is spread from the place where it started to other places in the body. * Patients with a laboratory test positive for hormone receptor and negative for HER2 before or up to 60 days after advanced/metastatic breast cancer diagnosis date. * Patients who received at least one initial prescription of Ibrance following a diagnosis of advanced/metastatic breast cancer.

This study will look at the safety of palbociclib treatment by looking at the number and severity of the side effects.

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Key information

Age range

18 year and older

Sex eligibility

Female

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.

Inclusion criteria

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

  • Adult women (≥ 18 years of age) with at least one visit with a breast cancer ICD10 diagnosis code (C50.x)
  • Patients with locally advanced breast cancer or metastatic breast cancer with a staging classification of stage III, stage IV (distant metastases).
  • Patients with a laboratory test positive for hormone receptor (HR) and negative for human epithelial growth factor receptor 2 (HER2) before or up to 60 days after advanced/metastatic breast cancer diagnosis date.
  • HR-positive is defined as any positive test for estrogen receptor or progesterone receptor.
  • HER2-negative is defined as any HER2-negative test and the absence of a positive test (immunohistochemistry positive (3+), fluorescence in situ hybridization positive/amplified).
  • Patients who received at least one initial prescription of Ibrance following a diagnosis of advanced/metastatic breast cancer

Exclusion criteria

Patients meeting any of the following criteria will not be included in the study:

  • Breast cancer with HR-negative and HER2-positive on laboratory testing.
  • More than a 90-day gap between breast cancer diagnosis date and next visit.
  • Patients who treated as off-label

Treatment and study plan

Ibrance

Drug

Patients who received at least one initial prescription of Ibrance following a diagnosis of advanced/metastatic breast cancer

Other names: Palbociclib

Primary outcomes

  1. Number of participants with adverse events that occur during treatment

    Time frame: From index date to last dose plus 28 days. Index is defined as the date of first prescription of Ibrance on participants diagnosed between 29 Aug 2015 through 30 Sep 2023

  2. Number of participants with associated risk factors

    Time frame: From index date to last dose plus 28 days. Index is defined as the date of first prescription of Ibrance on participants diagnosed between 29 Aug 2015 through 30 Sep 2023

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: From baseline to the date of death or censoring date, whichever occurs first on participants diagnosed between 29 Aug 2015 through 30 Sep 2023

  2. Real-World Tumor Response (rwTR)

    Time frame: From baseline to the date of death or censoring date, whichever occurs first on participants diagnosed between 29 Aug 2015 through 30 Sep 2023

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Real-world Database Study to Observe Safety and Effectiveness of Ibrance

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 8, 2025
Registry last updated
Apr 2, 2026

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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