Post Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE®

Recruiting

• Conditions: Breast Neoplasm

• Registration Number: NCT03445637
• Lead Sponsor: Pfizer

Brief Summary

This non-interventional study is designated as a Post Marketing Surveillance Study and is a commitment to Ministry of Food and Drug Safety (MFDS).

Before the approval of IBRANCE® in Korea, as a part of Risk Management Plan (RMP), which is required by MFDS, safety and efficacy information of new medication will be provided at minimum 1,000 participants administered in the setting of routine practice during the initial 9 years after the approval.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-31
• Study Start: 2018-02-08
• Study First Submitted QC: 2018-02-22
• Study First Posted: 2018-02-26
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-28
• Primary Completion: 2025-07-05
• Study Completion: 2025-07-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 540

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment-related adverse events during first 3 months	2018 ~ 2025	This is a prospective, observational, non-interventional, multi-center study in which subjects will be administered as part of routine practice at Korean health care centers by accredited physicians.

Trial Locations

Locations (1)

Pfizer Tower; 🇰🇷 Seoul, Korea, Republic of