Clinical Trials List
Protocol NumberA5481173
NCT Number(ClinicalTrials.gov Identfier)NCT05226871
Active
2023-07-31 - 2026-04-19
Others
Not yet recruiting1
Recruiting1
ICD-10Z85.3
Personal history of malignant neoplasm of breast
ICD-9V10.3
Personal history of malignant neoplasm of breast
A TREATMENT PROTOCOL FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED PALBOCICLIB CLINICAL STUDIES
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 李芳 Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Principal Investigator
Wei-Pang Chung
Co-Principal Investigator
- 黃怡菁 Division of Hematology & Oncology
- 楊舜如 Division of Hematology & Oncology
- Chun-Hui Lee Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Breast Cancer 、Head and Neck Cancer
Objectives
The purpose of this trial is to continue providing treatment and collect limited safety data for eligible participants who have been determined by the trial administrator to have sustained clinical benefit from the trial treatment in the palbociclib clinical trial (primary trial) commissioned by Pfizer.
Test Drug
膠囊劑
錠劑
錠劑
Active Ingredient
PD-332991 (Palbociclib)
Letrozole
Letrozole
Dosage Form
130
110
110
Dosage
75 mg/ 100 mg/ 125 mg
2.5 mg
2.5 mg
Endpoints
• Adverse events (AEs) leading to permanent discontinuation of experimental treatment
• Serious adverse events (SAEs)
• Serious adverse events (SAEs)
Inclution Criteria
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
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
Exclusion Criteria:
Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study
Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study
The Estimated Number of Participants
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Taiwan
1 participants
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Global
35 participants
