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

November 22, 2025 updated by: Pfizer

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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)

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100021
        • Cancer Hospital Chinese Academy of Medical Science
    • Anhui
      • Hefei, Anhui, China, 230022
        • The First Affiliated Hospital of Anhui Medical University
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Beijing Cancer Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Harbin Medical University Cancer Hospital
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
    • Liaoning
      • Shenyang, Liaoning, China, 110042
        • Liaoning Cancer Hospital and Institute
      • Shenyang, Liaoning, China, 110167
        • The First Hospital of China Medical University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200025
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
  • Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
  • South Korea
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, South Korea, 10408
        • National Cancer Center
    • Seoul-teukbyeolsi [seoul]
      • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 06351
        • Samsung Medical Center
  • Taiwan
      • Tainan, Taiwan, 704302
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10449
        • Mackay Memorial Hospital
  • Thailand
      • Bangkok, Thailand, 10700
        • Department of Medicine, Faculty of Medicine Siriraj Hospital
    • Bangkok
      • Ratchathewi, Bangkok, Thailand, 10400
        • Faculty of Medicine, Ramathibodi Hospital, Mahidol University
  • Ukraine
      • Dnipro, Ukraine, 49102
        • Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council
      • Ivano-Frankivsk, Ukraine, 76000
        • Municipal non-profit enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council
    • Chernivetska Oblast
      • Chernivtsi, Chernivetska Oblast, Ukraine, 58013
        • Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center"
  • United States
    • California
      • San Francisco, California, United States, 94158
        • UCSF Medical Center at Mission Bay

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm 1
Cetuximab
Drug: Cetuximab
Intravenous (IV) infusion
Experimental: Arm 2
Palbociclib plus Cetuximab
Drug: Cetuximab
Intravenous (IV) infusion
Drug: Palbociclib
oral
Other Names:
  • IBRANCE
Other: Arm 3
Palbociclib plus Fulvestrant
Drug: Palbociclib
oral
Other Names:
  • IBRANCE
Drug: Fulvestrant
Intramuscular (IM)
Other: Arm 4
Palbociclib plus Letrozole
Drug: Palbociclib
oral
Other Names:
  • IBRANCE
Drug: Letrozole
oral

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 26, 2022

First Submitted That Met QC Criteria

January 26, 2022

First Posted (Actual)

February 7, 2022

Study Record Updates

Last Update Posted (Estimated)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 22, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5481173
  • 2021-005735-22 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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