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

Study Overview
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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)

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

Conditions
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Breast Cancer, Head and Neck Cancer

Intervention / Treatment
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* Drug: Palbociclib
* Drug: Cetuximab
* Drug: Fulvestrant
* Drug: Letrozole


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br>Cetuximab | Drug: Cetuximab<br>* Intravenous (IV) infusion<br>|
| Experimental: Arm 2<br>Palbociclib plus Cetuximab | Drug: Palbociclib<br>* oral<br>* Other names: IBRANCE;Drug: Cetuximab<br>* Intravenous (IV) infusion<br>|
| Other: Arm 3<br>Palbociclib plus Fulvestrant | Drug: Palbociclib<br>* oral<br>* Other names: IBRANCE;Drug: Fulvestrant<br>* Intramuscular (IM)<br>|
| Other: Arm 4<br>Palbociclib plus Letrozole | Drug: Palbociclib<br>* oral<br>* Other names: IBRANCE;Drug: Letrozole<br>* oral<br>|

What is the study measuring?
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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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hormone Receptor Positive Advanced Breast Cancer, Squamous Cell Carcinoma of the Head and Neck