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

Breast Cancer Clinical Trial

Official title:

A TREATMENT PROTOCOL FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED PALBOCICLIB CLINICAL STUDIES

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05226871
• Other study ID #: A5481173
• Secondary ID: 2021-005735-22
• Status: Recruiting
• Phase: Phase 2
• Start date: July 7, 2022
• Est. completion date: April 19, 2026

Study information

• Verified date: November 2023
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

This is an open-label study to provide continued access to treatment for eligible participants who continue to derive clinical benefit as determined by the investigator from study intervention(s) in a Pfizer-sponsored palbociclib clinical study (Parent Study)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: April 19, 2026
• Est. primary completion date: April 19, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• Palbociclib
oral
• Cetuximab
Intravenous (IV) infusion
• Fulvestrant
Intramuscular (IM)
• Letrozole
oral

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang-si	Gyeonggi-do
Korea, Republic of	Samsung Medical Center	Seoul	Seoul-teukbyeolsi [seoul]
Korea, Republic of	Seoul National University Hospital	Seoul
Mexico	Hospital Universitario "Dr. Jose Eleuterio Gonzalez"	Monterrey	Nuevo LEÓN
Ukraine	Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center"	Chernivtsi	Chernivetska Oblast
Ukraine	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
United States	UCSF Medical Center at Mission Bay	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Korea, Republic of,  Mexico,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number/Percentage of Participants with Treatment-Emergent Adverse Events (AEs) Leading to Permanent Discontinuation of Study Treatment and Serious Adverse Events (SAEs)	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.	Baseline up to 28 days after last dose of study intervention

External Links

•   To obtain contact information for a study center near you, click here.