Trial Title:
A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC
NCT ID:
NCT05766410
Condition:
Breast Cancer
Hormone Receptor-positive Breast Cancer
Hormone Therapy
Conditions: Official terms:
Breast Neoplasms
Letrozole
Palbociclib
Conditions: Keywords:
CDK4, 6 inhibitor
Neoadjuvant therapy
Hormone therapy
Hormone Receptor-positive Breast Cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Palbociclib
Description:
CDK4, 6 inhibitor
Arm group label:
Palbociclib/Letrozole
Other name:
Ibrance
Intervention type:
Drug
Intervention name:
Ribociclib
Description:
CDK4, 6 inhibitor
Arm group label:
Ribociclib/Letrozole
Other name:
Kisqali
Intervention type:
Drug
Intervention name:
Abemaciclib
Description:
CDK4, 6 inhibitor
Arm group label:
Abemaciclib/Letrozole
Other name:
Venizio
Intervention type:
Drug
Intervention name:
Letrozole
Description:
Endocrine therapy
Arm group label:
Abemaciclib/Letrozole
Arm group label:
Palbociclib/Letrozole
Arm group label:
Ribociclib/Letrozole
Other name:
Femara
Summary:
The 3 FDA-approved CDK4, 6 inhibitors, palbociclib, ribociclib, and abemciclib, all
provided progression-free survival benefits when combined with endocrine therapy in
advanced ER+/HER2- breast cancer. But, not all of them provided overall survival benefit
in the same setting. One of the proposed mechanisms that influence the overall survival
difference is from the different influence of the 3 CDK4, 6 inhibitors on tumor
microenvironment and/ or immune system. However, there was no head-to-head comparison of
the 3 CDK4, 6 inhibitors in the same study. Neoadjuvant therapy provides a window to
obtain tissue samples before treatment, during treatment, and after treatment. We aim to
compare the immune modulation effects of palbociclib, ribociclib, and abemaciclib with
letrozole in neoadjuvant treatment for ER+/HER2- early breast cancer.
Detailed description:
The 3 FDA-approved CDK4, 6 inhibitors, palbociclib, ribociclib, and abemciclib, all
provided progression-free survival benefits when combined with endocrine therapy in
advanced ER+/HER2- breast cancer. But, not all of them provided overall survival benefit
in the same setting. One of the proposed mechanisms that influence the overall survival
difference is from the different influence of the 3 CDK4, 6 inhibitors on tumor
microenvironment and/ or immune system. However, there was no head-to-head comparison of
the 3 CDK4, 6 inhibitors in the same study. Neoadjuvant therapy provides a window to
obtain tissue samples before treatment, during treatment, and after treatment. We aim to
compare the immune modulation effects of palbociclib, ribociclib, and abemaciclib with
letrozole in neoadjuvant treatment for ER+/HER2- early breast cancer. We will collect
tumor tissue, blood, and stool samples prospectively before treatment, at 2 weeks after
treatment, and after 12 weeks of treatment at the time of surgery. Immune modulation
effects will be compared between 3 treatment groups from breast tumor RNAseq analysis.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Female patients aged ≥ 20 years old at the time of informed consent.
- Patient has a histologically and/or cytologically confirmed diagnosis of
estrogen-receptor positive and/or progesterone receptor positive breast cancer based
on the most recently analyzed tissue sample and all tested by local laboratory. with
estrogen receptor positive (>10%) on IHC staining and HER2 negative (IHC 0+/1+, or
IHC 2+ plus FISH negative)
- Stage II to III
- With adequate organ function
- ECOG 0-1
Exclusion Criteria:
- Pregnant or nursing (lactating) women
- Women of child-bearing potential unless using highly effective methods of
contraception during study drug dosing and for 12 months post-dosing
- Patients with active systemic infections or known to have AIDS or to test positive
for HIV antibody at Screening
- Any other disease or condition that could interfere with participation in the study
according to the study protocol, or with the ability of the patients to cooperate
and comply with the study procedures.
Gender:
Female
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Oncology, National Taiwan University Hospital
Address:
City:
Taipei City
Zip:
100
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Yen-Shen Lu, MD, PhD
Phone:
886-2-23123456
Phone ext:
67009
Email:
yslu@ntu.edu.tw
Investigator:
Last name:
Yen-Shen Lu, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Ching-Hung Lin, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Dwan-Ying Chang, MD
Email:
Sub-Investigator
Investigator:
Last name:
Tom Wei-Wu Chen, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
I-Chun Chen, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Wei-Li Ma, MD
Email:
Sub-Investigator
Investigator:
Last name:
Ming-Yang Wang, MD, PhD
Email:
Sub-Investigator
Facility:
Name:
Department of Oncology,National Taiwan University Hospital
Address:
City:
Taipei
Zip:
100
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Yen-Shen Lu, M.D.,Ph.D
Phone:
886-2-23123456
Phone ext:
62859
Email:
yslu@ntu.edu.tw
Contact backup:
Last name:
I-Chun Chen, M.D.,Ph.D
Phone:
886-2-23123456
Phone ext:
62859
Email:
A00523@ntucc.gov.tw
Investigator:
Last name:
Ching-Hung Lin, M.D.,Ph.D
Email:
Sub-Investigator
Investigator:
Last name:
Dwan-Ying Chang, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Tom Wei-Wu Chen, M.D.,Ph.D
Email:
Sub-Investigator
Investigator:
Last name:
I-Chun Chen, M.D.,Ph.D
Email:
Sub-Investigator
Investigator:
Last name:
Ming-Yang Wang, M.D.,Ph.D
Email:
Sub-Investigator
Investigator:
Last name:
Wei-Li Ma, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Yen-Shen Lu, M.D.,Ph.D
Email:
Principal Investigator
Start date:
September 16, 2022
Completion date:
September 30, 2026
Lead sponsor:
Agency:
National Taiwan University Hospital
Agency class:
Other
Source:
National Taiwan University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05766410
