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

NCT ID: NCT06962969

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2025-11-28

Brief Summary

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.

Conditions

Advanced or Metastatic Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Ibrance (palbociclib)

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

Ibrance

Intervention Type: DRUG

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

Interventions

Ibrance

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

Intervention Type: DRUG

Other Intervention Names

Palbociclib

Eligibility Criteria

Inclusion Criteria

• 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.

1. HR-positive is defined as any positive test for estrogen receptor or progesterone receptor.

2. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Central Contacts

Pfizer CT.gov Call Center

Role: CONTACT

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Other Identifiers

A5481186

Identifier Type: -

Identifier Source: org_study_id