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

NCT05226871 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: A54811732021-005735-22
• Study Type: interventional
• Target: 35
• Locations: 7 countries
• Sites: 23

Brief 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).

Conditions

Breast Cancer; Head and Neck Cancer

Keywords

Hormone Receptor Positive Advanced Breast Cancer; Squamous Cell Carcinoma of the Head and Neck

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Arm 1

OTHER

Cetuximab

Drug: Cetuximab

Arm 2

EXPERIMENTAL

Palbociclib plus Cetuximab

Drug: Palbociclib; Drug: Cetuximab

Arm 3

OTHER

Palbociclib plus Fulvestrant

Drug: Palbociclib; Drug: Fulvestrant

Arm 4

OTHER

Palbociclib plus Letrozole

Drug: Palbociclib; Drug: Letrozole

Interventions

Palbociclib DRUG

oral

Also known as: IBRANCE

Arm 2; Arm 3; Arm 4

Cetuximab DRUG

Intravenous (IV) infusion

Arm 1; Arm 2

Fulvestrant DRUG

Intramuscular (IM)

Arm 3

Letrozole DRUG

oral

Arm 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (23)

UCSF Medical Center at Mission Bay

San Francisco, California, 94158, United States

Location

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

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

Guangzhou, Guangdong, 510000, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, 110042, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 110167, China

Location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Cancer Hospital Chinese Academy of Medical Science

Beijing, 100021, China

Location

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, 64460, Mexico

Location

National Cancer Center

Goyang-si, Gyeonggi-do, 10408, South Korea

Location

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [seoul], 06351, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

National Cheng Kung University Hospital

Tainan, 704302, Taiwan

Location

Mackay Memorial Hospital

Taipei, 10449, Taiwan

Location

Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Ratchathewi, Bangkok, 10400, Thailand

Location

Department of Medicine, Faculty of Medicine Siriraj Hospital

Bangkok, 10700, Thailand

Location

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

Chernivtsi, Chernivetska Oblast, 58013, Ukraine

Location

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

Dnipro, 49102, Ukraine

Location

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

Ivano-Frankivsk, 76000, Ukraine

Location

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

palbociclib; Cetuximab; Fulvestrant; Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 7, 2022
• Study Start: July 7, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

TW (2); UA (3); ME (1); TH (2); US (1); CN (11); KR (3)