A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC (ORACLE-RIPA)
Breast Cancer, Hormone Receptor-positive Breast Cancer, Hormone Therapy
About this trial
This is an interventional basic science trial for Breast Cancer focused on measuring CDK4, 6 inhibitor, Neoadjuvant therapy, Hormone therapy, Hormone Receptor-positive Breast Cancer
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.
Sites / Locations
- Department of Oncology, National Taiwan University HospitalRecruiting
- Department of Oncology,National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
Palbociclib/Letrozole
Ribociclib/Letrozole
Abemaciclib/Letrozole
CDK4, 6 inhibitor and endocrine therapy
CDK4, 6 inhibitor and endocrine therapy
CDK4, 6 inhibitor and endocrine therapy