Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-04-13 @ 7:59 AM
Study NCT ID:
NCT06962969
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-10
First Post:
2025-04-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Understand the Patients Confirmed to Have Advanced or Metastatic Breast Cancer and Receiving Palbociclib Treatment Using a Real-world Database
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
Real-world Database Study to Observe Safety and Effectiveness of Ibrance
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: