Breast Cancer, Head and Neck Cancer
Conditions
Keywords
Hormone Receptor Positive Advanced Breast Cancer, Squamous Cell Carcinoma of the Head and Neck
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).
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)
Interventions
DRUGPalbociclib
oral
DRUGCetuximab
Intravenous (IV) infusion
DRUGFulvestrant
Intramuscular (IM)
DRUGLetrozole
oral
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number/Percentage of Participants with Treatment-Emergent Adverse Events (AEs) Leading to Permanent Discontinuation of Study Treatment and Serious Adverse Events (SAEs) | 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. |
Countries
China, Mexico, South Korea, Taiwan, Thailand, Ukraine, United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed