ClinicalTrials.gg
CompletedNCT03445637Updated Nov 24, 2025

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

An observational study in Breast Neoplasm, sponsored by Pfizer. Completed at 1 site in South Korea. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-24.

Sponsored by Pfizer · Observational

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Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
552
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 182 studies in Breast Neoplasms by Pfizer — 6 open to participants now, 26 under way, 7 of them phase 3. Breast Neoplasms · Pfizer.

Enrollment
24th of 56
552 · median 399
Started
2018
with 5 others
Observational
56 of 182
1 open now
Registered
102nd of 182
by date

Among the 182 studies in Breast Neoplasms by Pfizer, this one is the 24th largest by enrollment of the 56 observational ones that give a count, is one of 6 that started in 2018, is one of 56 observational ones, and was the 102nd registered.

Breast Neoplasms

14,832 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.

Browse Breast Neoplasms studies →

Open to participants now

6 of the 182 studies in Breast Neoplasms by Pfizer are open now, in 12 countries. Recruiting first, the newest first:

1 more — sign in →

By country, each count listing its studies:

All 6 open studies →

Who these studies take

Of the 2,399 Breast Neoplasms studies recruiting now, 1,570 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

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02

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.

03

Conditions studied

  • Breast Neoplasm

Browse trials for

Keywords

  • Metastatic breast cancer
  • safety
  • ibrance
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All participants enrolled should meet the usual prescribing criteria for IBRANCE® as per the Local Product Document (LPD) and should be entered into the study at the physician's discretion.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women of ≥18 years of age with proven diagnosis of advanced/ breast cancer (locoregionally recurrent or metastatic disease).
  • Estrogen Receptor+ (ER+) and/or Progesterone Receptor+ (PgR+) tumor based on local laboratory results (test as per local practice).
  • Human Epidermal Growth Factor Receptor 2 -(-) breast cancer based on local laboratory results (test as per local practice or local guidelines)
  • Patients must be appropriate candidates for hormone therapy.
  • Evidence of a personally signed and dated document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
  • During the post marketing surveillance (PMS) period, patients who initially administer IBRANCE®

Exclusion criteria

Exclusion Criteria

  • Known to letrozole or its or to any Cyclin-Dependent Kinase 4/6 (CDK4/6) inhibitor excipients.
  • Pregnant women
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
552 participants (actual)
Patient registry
No

This study also gives Palbociclib. No intervention listed here names it: that was found by reading the record.

06

What researchers measure

Primary outcomes

  1. Treatment-related adverse events during first 3 months

    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.

    Time frame: 2018 ~ 2025

07

Study locations

1 site
  • Pfizer
    Seoul, South Korea
08

References and documents

Individual participant data

Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2018 to primary completion in Jul 2025, 89 months.

Of 189 industry-sponsored observational studies under Breast Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 70. This study's 89 months is above that.

Counting every sponsor, half of 1,381 studies reached it within 55 months; a quarter within 25 and three quarters within 125.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 31, 2018
First posted
Feb 26, 2018
StartActual
Feb 8, 2018
Primary completionActual
Jul 13, 2025
CompletionActual
Jul 13, 2025
Last update
Nov 24, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03445637
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Feb 26, 2018
Start date
Feb 8, 2018
Primary completion
Jul 13, 2025
Completion
Jul 13, 2025
Last update
Nov 24, 2025

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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