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

NCT ID: NCT05226871

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-07

Study Completion Date

2026-12-31

Brief Summary

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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).

Detailed Description

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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)

Conditions

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Breast Cancer Head and Neck Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Cetuximab

Group Type OTHER

Cetuximab

Intervention Type DRUG

Intravenous (IV) infusion

Arm 2

Palbociclib plus Cetuximab

Group Type EXPERIMENTAL

Palbociclib

Intervention Type DRUG

oral

Cetuximab

Intervention Type DRUG

Intravenous (IV) infusion

Arm 3

Palbociclib plus Fulvestrant

Group Type OTHER

Palbociclib

Intervention Type DRUG

oral

Fulvestrant

Intervention Type DRUG

Intramuscular (IM)

Arm 4

Palbociclib plus Letrozole

Group Type OTHER

Palbociclib

Intervention Type DRUG

oral

Letrozole

Intervention Type DRUG

oral

Interventions

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Palbociclib

oral

Intervention Type DRUG

Cetuximab

Intravenous (IV) infusion

Intervention Type DRUG

Fulvestrant

Intramuscular (IM)

Intervention Type DRUG

Letrozole

oral

Intervention Type DRUG

Other Intervention Names

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IBRANCE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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UCSF Medical Center at Mission Bay

San Francisco, California, United States

Site Status

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Site Status

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status

Hubei Cancer Hospital

Wuhan, Hubei, China

Site Status

The First Hospital of Jilin University

Changchun, Jilin, China

Site Status

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, China

Site Status

The First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

Cancer Hospital Chinese Academy of Medical Science

Beijing, , China

Site Status

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, Mexico

Site Status

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Site Status

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [seoul], South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

National Cheng Kung University Hospital

Tainan, , Taiwan

Site Status

Mackay Memorial Hospital

Taipei, , Taiwan

Site Status

Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Ratchathewi, Bangkok, Thailand

Site Status

Department of Medicine, Faculty of Medicine Siriraj Hospital

Bangkok, , Thailand

Site Status

Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center"

Chernivtsi, Chernivetska Oblast, Ukraine

Site Status

Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council

Dnipro, , Ukraine

Site Status

Municipal non-profit enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council

Ivano-Frankivsk, , Ukraine

Site Status

Countries

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United States China Mexico South Korea Taiwan Thailand Ukraine

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=A5481173

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

Other Identifiers

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2021-005735-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A5481173

Identifier Type: -

Identifier Source: org_study_id

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