The Resistance and Immune Response to Palbociclib in Breast Cancer
Prospective Longitudinal Biomarker Study of Acquired Resistance and Immune Response to Palbociclib in Breast Cancer
1 other identifier
interventional
100
1 country
1
Brief Summary
The investigators propose to conduct a biomarker and molecular profiling study in longitudinally paired tumor biopsies and serum from patients with Hormone Receptor positive (HR+) metastatic Breast Cancer (BC) treated with Palbociclib in combination with endocrine therapies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 24, 2017
CompletedFirst Submitted
Initial submission to the registry
December 11, 2017
CompletedFirst Posted
Study publicly available on registry
January 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2022
CompletedJanuary 17, 2018
January 1, 2018
3 years
December 11, 2017
January 15, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Biomarker of palbociclib in metastatic breast cancer
Biomarker of acquired resistance and immune response to palbociclib in metastatic breast cancer from whole exome sequencing, RNASeq, circulating tumor DNA and flow cytometry.
24.8 months (median progression free survival in palbociclib plus letrozole treatment (according to PALOMA-2 trial)
Interventions
At baseline, 100 tumor/blood samples will be banked. Only \~60 will be profiled if the paired samples are acquired post-progression or on-treatment. On-treatment blood samples will be serially collected and banked from all consenting patients.
Eligibility Criteria
You may qualify if:
- Hormone receptor positive, metastatic breast cancer
- Treated by palbociclib with endocrine therapy
You may not qualify if:
- Hormone receptor negative breast cancer
- Treated without palbociclib
- Refuse and withdrawal to this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, 06351, South Korea
Related Publications (1)
Park YH, Im SA, Park K, Wen J, Lee KH, Choi YL, Lee WC, Min A, Bonato V, Park S, Ram S, Lee DW, Kim JY, Lee SK, Lee WW, Lee J, Kim M, Kim HS, Weinrich SL, Ryu HS, Kim TY, Dann S, Kim YJ, Fernandez DR, Koh J, Wang S, Park SY, Deng S, Powell E, Ravi RK, Bienkowska J, Rejto PA, Park WY, Kan Z. Longitudinal multi-omics study of palbociclib resistance in HR-positive/HER2-negative metastatic breast cancer. Genome Med. 2023 Jul 20;15(1):55. doi: 10.1186/s13073-023-01201-7.
PMID: 37475004DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 11, 2017
First Posted
January 17, 2018
Study Start
October 24, 2017
Primary Completion
October 31, 2020
Study Completion
October 31, 2022
Last Updated
January 17, 2018
Record last verified: 2018-01