Actively Recruiting
A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC
Led by National Taiwan University Hospital · Updated on 2023-03-16
60
Participants Needed
2
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 60 years or older at the time of consent
- Diagnosed with estrogen receptor-positive and/or progesterone receptor-positive breast cancer confirmed by local lab
- HER2 negative status confirmed by immunohistochemistry or FISH
- Breast cancer stage II to III
- Adequate organ function
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
You will not qualify if you...
- Pregnant or nursing women
- Women of child-bearing potential not using effective contraception during treatment and for 12 months after
- Active systemic infections or HIV positive
- Any other medical condition that may interfere with study participation or protocol compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Department of Oncology, National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
2
Department of Oncology,National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
Research Team
Y
Yen-Shen Lu, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here