NCT07096024Completed
A Study to Understand About the Study Medicine Palbociclib in Breast Cancer Patients After it is Out in the Japanese Market
Ibrance® Post-Marketing Database Study Incidence of Interstitial Lung Disease in Inoperable or Recurrent Breast Cancer Patients Treated With Palbociclib in a Post-marketing Setting: Cohort Study Using the Medical Data Vision (MDV) Database
Source: ClinicalTrials.gov · Last updated 10 Jul 2026
Brief summary (registry, in English)
The purpose of the study is to: * compare the chances of getting interstitial lung disease (ILD) in new users of palbociclib plus fulvestrant to new users of fulvestrant alone (using data from before palbociclib was out in the market) * look into the factors that can cause ILD in new users of palbociclib. This study uses patient data without giving out any personal information of the patient. This data is taken from a hospital-based claims database of the MDV database, that includes data from more than 400 hospitals in Japan. This study will use data of patients who are: * diagnosed with breast cancer that include newly treated with palbociclib and/or other endocrine-based therapies for inoperable or recurrent breast cancer between 25 November 2011 and 30 November 2024.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 95637 (actual)
- First submitted
- 24 Jul 2025
- Start date
- 21 Jan 2025
- Primary completion date
- 7 Feb 2025
- Lead sponsor
- Pfizer
- Diseases
- Lung cancer, Childhood cancers
- NCT number
- NCT07096024
What you commit to
- Study type: Observational
- Participants enrolled: 95637
- From 21 Jan 2025 to the primary completion date, 7 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Having any records of anti-HER2 medication (e.g., trastuzumab, pertuzumab, lapatinib or trastuzumab emtansine) from 25 November 2011 to 31 December 2024.
Other illness
- Having any records of second primary cancer with definitive diagnosis
Who the study is looking for
- Having prescription records of drugs for endocrine therapy (aromatase inhibitors, SERDs, SERMs, and CDK4/6 inhibitors) from 25 November 2011 to 31 December 2024.
- Having any breast cancer records with definitive diagnosis in the same month as the first prescription date.
- Having any records in MDV database on or before 6 months prior to the first prescription date (\<= -180 days: first prescription date = 0 day).
- Having any records in MDV database within 6 months prior to the first prescription date (-180 days to 0 day).
Age in the registry: 15 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pfizer Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.