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NCT05912933
A Study to Learn About the Relationship Between Hepatic Impairment and Myelosuppression (Decreased Bone Marrow Function) in Breast Cancer Patients Treated With the Study Medicine Palbociclib (Pal-bow-sai-klib)
trial in Breast Cancer in 733 participants. Completed in 30 August 2024.
30 August 2024
Quick facts
| Lead sponsor | Pfizer |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 733 |
| Start date | 19 August 2024 |
| Primary completion | 30 August 2024 |
| Estimated completion | 30 August 2024 |
| Sites | 1 location across United States |
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Pfizer — full company profile →
Who can join
0 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate incidence of grade 4 neutropenia in patients who have hepatic impairment and use the study medicine Palbociclib. This study is seeking participants: * treated with the study medicine Palbociclib * having any breast cancer records in same month as the index date (the first prescription date) * having prescription records of palbociclib from 20 December 2016 to 29 February 2024 The study design is a cohort study. This study design uses de-identified patient data from a hospital based electronic medical record and claim database in Japan. One of the important side effects of taking Palbociclib is neutropenia (decreased count of neutrophils - a type of white blood cell). In this study, the relationship between neutropenia caused by Palbociclib and hepatic impairment was studied after it was released to the market. To do that, the study gathered details of breast cancer patients newly treated with Palbociclib from 23 hospitals and 10 medical institutes across Japan. The below patient details were collected: * dose of Palbociclib * other medicines prescribed for cancer * age * gender * past information on cancer treatments * laboratory findings at baseline The result was based on the neutrophil count collected from the laboratory data. Around 1300 patients newly treated with Palbociclib for breast cancer was calculated by the medical information database network (MID-NET) in 6 years from 15 December 2017.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Targeting cyclin-dependent kinase 2 (CDK2) interactions with cyclins and Speedy 1 (Spy1) for cancer and male contraception.
Giarolla J, Holdaway KA, Nazari M, Aiad L, et al · · 2025 · cited 2× · PMID 40034037 · DOI 10.1080/17568919.2025.2463868
Verify or expand the search:
- PubMed search for NCT05912933
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05912933 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pfizer
- Last refreshed: 13 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05912933.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing