Study for Participants Continuing From Pfizer-sponsored Palbociclib (a Study Medicine) Studies
NCT ID: NCT05226871
Last Updated: 2025-11-25
Study Results
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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ACTIVE_NOT_RECRUITING
PHASE2
35 participants
INTERVENTIONAL
2022-07-07
2026-12-31
Brief Summary
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* 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).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
Cetuximab
Cetuximab
Intravenous (IV) infusion
Arm 2
Palbociclib plus Cetuximab
Palbociclib
oral
Cetuximab
Intravenous (IV) infusion
Arm 3
Palbociclib plus Fulvestrant
Palbociclib
oral
Fulvestrant
Intramuscular (IM)
Arm 4
Palbociclib plus Letrozole
Palbociclib
oral
Letrozole
oral
Interventions
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Palbociclib
oral
Cetuximab
Intravenous (IV) infusion
Fulvestrant
Intramuscular (IM)
Letrozole
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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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
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
The First Hospital of Jilin University
Changchun, Jilin, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Cancer Hospital Chinese Academy of Medical Science
Beijing, , China
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, Mexico
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], South Korea
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, Thailand
Department of Medicine, Faculty of Medicine Siriraj Hospital
Bangkok, , Thailand
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, , Ukraine
Countries
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Related Links
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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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