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

NCT03445637 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 552

Last updated 2025-11-24

No results posted yet for this study

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.

Conditions

  • Breast Neoplasm

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-08
Primary Completion
2025-07-13
Completion
2025-07-13

Countries

  • South Korea

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03445637 on ClinicalTrials.gov