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

NCT06962969 | Completed

• 1 other identifier: A5481186
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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

Keywords

breast cancer; Palbociclib

Outcome Measures

Primary Outcomes (2)

• Number of participants with adverse events that occur during treatment

  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

• Number of participants with associated risk factors

  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 (2)

• Overall Survival (OS)

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

• Real-World Tumor Response (rwTR)

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

Study Arms (1)

Ibrance (palbociclib)

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

Drug: Ibrance

Interventions

Ibrance DRUG

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

Also known as: Palbociclib

Ibrance (palbociclib)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study participants will be patients diagnosed with HR(+)/HER2(-) advanced/metastatic breast cancer between August 29, 2015 and September 30, 2023 who meet the general prescribing criteria for Palbociclib in South Korea according to the national product manual, and who meet the following inclusion and exclusion criteria, as determined by data from one year prior to the Ibrance approval date

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer New York

New York, New York, 10001, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 8, 2025
• Study Start: June 30, 2025
• Primary Completion: October 23, 2025
• Study Completion: October 23, 2025
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)