Palbociclib Pharmacokinetics Study In Postmenopausal Chinese Women With ER (+), HER2 (-) Advanced Breast Cancer
NCT ID: NCT02499146
Last Updated: 2025-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
26 participants
INTERVENTIONAL
2015-09-11
2024-12-24
Brief Summary
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The single and multiple 125 mg oral dose pharmacokinetics of Palbociclib will be characterized.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Cohort 1
Combination therapy of palbociclib and letrozole
Palbociclib
125 mg orally once daily with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle
Letrozole
2.5 mg , orally once daily (continuously)
Interventions
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Palbociclib
125 mg orally once daily with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle
Letrozole
2.5 mg , orally once daily (continuously)
Eligibility Criteria
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Inclusion Criteria
a. Postmenopausal women: i. Prior bilateral surgical oophorectomy; or ii. Medically confirmed post-menopausal status defined as spontaneous cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause b. Documentation of histologically or cytologically confirmed diagnosis of: i. ER(+) breast cancer. c. Documentation of HER2(-) breast cancer. d. Previously untreated with any systemic anti cancer therapy for their locoregionally recurrent or metastatic ER+ disease.
* Measurable disease as defined per RECIST v.1.1 or bone-only disease. - Tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measurable if disease progression at the treated site after completion of therapy is clearly documented.
Exclusion Criteria
* Patients with advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions \[pleural, pericardial, peritoneal\], pulmonary lymphangitis, and over 50% liver involvement).
18 Years
65 Years
FEMALE
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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Beijing Cancer Hospital/Oncology department
Beijing, Beijing Municipality, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Guangdong General Hospital/Department of Breast Surgery
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The first hospital of jilin university
Changchun, Jilin, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, , China
Countries
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References
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Yu Y, Sun W, Liu Y, Wang D. Pharmacodynamic Modeling of CDK4/6 Inhibition-Related Biomarkers and the Characterization of the Relationship Between Biomarker Response and Progression-Free Survival in Patients With Advanced Breast Cancer. J Clin Pharmacol. 2022 Mar;62(3):376-384. doi: 10.1002/jcph.1971. Epub 2021 Nov 16.
Xu B, Li H, Zhang Q, Sun W, Yu Y, Li W, Wang S, Liao N, Shen P, Liu Y, Huang Y, Linn C, Zhao H, Jiang J, Wang D. Pharmacokinetics, safety, activity, and biomarker analysis of palbociclib plus letrozole as first-line treatment for ER+/HER2- advanced breast cancer in Chinese women. Cancer Chemother Pharmacol. 2021 Jul;88(1):131-141. doi: 10.1007/s00280-021-04263-9. Epub 2021 Apr 9.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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NCT02499146
Identifier Type: REGISTRY
Identifier Source: secondary_id
A5481019
Identifier Type: -
Identifier Source: org_study_id