Study for Participants Continuing From Pfizer-sponsored Palbociclib (a Study Medicine) Studies

NCT05226871 · tracked via the Priya Life Science USA tracker

Sponsor

Pfizer

Phase

Phase 2

Started

2022-07-07

Last updated

2026-09-09

Condition(s) studied

Breast CancerHead and Neck Cancer

Investigational drug(s) / intervention(s)

PalbociclibCetuximabFulvestrantLetrozole

Palbociclib: oral

Cetuximab: Intravenous (IV) infusion

Fulvestrant: Intramuscular (IM)

Letrozole: oral

Study summary

The purpose of this clinical trial is to provide study medicine(s) and learn about their safety. This study is seeking participants who:

* Have benefited from ongoing study treatment as determined by the study doctor in a Pfizer-sponsored palbociclib Parent Study
* Must agree to follow the reproductive criteria
* Are willing and able to comply with all scheduled visits, treatment plans, and other study procedures
* Can give signed informed consent documents

Participants in this study will continue to receive treatment as they were in the parent study. The time by which participants will take part in this study is retrospective (after completed parent study). We will examine the experiences of people receiving the study medicine(s). This will help us determine if the study medicine(s) are safe. During this time, the participants will be monitored for the safety of the study medicine(s).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Any participant who is receiving study treatment and deriving clinical benefit as determined by the investigator in a Pfizer-sponsored palbociclib Parent Study * Participants must agree to follow the reproductive criteria * Participants who are willing and able to comply with all scheduled visits, treatment plans, and other study procedures * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent document and protocol Exclusion Criteria: * Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study

Primary outcome measure(s)

Number/Percentage of Participants with Treatment-Emergent Adverse Events (AEs) Leading to Permanent Discontinuation of Study Treatment and Serious Adverse Events (SAEs) — Baseline up to 28 days after last dose of study intervention
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Trial sites (23)

Facility	City	Region
UCSF Helen Diller Comprehensive Cancer Center at Mission Bay	San Francisco	California
The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
Beijing Cancer Hospital	Beijing	Beijing Municipality
Sun Yat-sen Memorial Hospital of Sun Yat-sen University	Guangzhou	Guangdong
Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
Henan Cancer Hospital	Zhengzhou	Henan
Hubei Cancer Hospital	Wuhan	Hubei
The First Hospital of Jilin University	Changchun	Jilin
Liaoning Cancer Hospital and Institute	Shenyang	Liaoning
The First Hospital of China Medical University	Shenyang	Liaoning
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai Municipality
Cancer Hospital Chinese Academy of Medical Science	Beijing	China
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"	Monterrey	Nuevo León
National Cancer Center	Goyang-si	Gyeonggi-do
Samsung Medical Center	Seoul	Seoul-teukbyeolsi [seoul]
Seoul National University Hospital	Seoul	South Korea
National Cheng Kung University Hospital	Tainan	Taiwan
Mackay Memorial Hospital	Taipei	Taiwan
Faculty of Medicine, Ramathibodi Hospital, Mahidol University	Ratchathewi	Bangkok
Department of Medicine, Faculty of Medicine Siriraj Hospital	Bangkok	Thailand
Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center"	Chernivtsi	Chernivetska Oblast
Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council	Dnipro	Ukraine
Municipal non-profit enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council	Ivano-Frankivsk	Ukraine

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05226871 on ClinicalTrials.gov ↗ ← All trials in the USA