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Clinical Trials in Taiwan / NCT05226871
Active, not recruiting Phase 2

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

NCT05226871 · tracked via the Priya Life Science Taiwan 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)

Palbociclib →Cetuximab →Fulvestrant →Letrozole →

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
No
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)

FacilityCityRegionStatus
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

📄 Ibrance (palbociclib) drug profile →

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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 Taiwan