NCT05766410 A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC
| NCT ID | NCT05766410 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | National Taiwan University Hospital |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-09-16 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2022-09-16 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Yen-Shen Lu, MD, PhD
PRINCIPAL INVESTIGATOR
National Taiwan University Hospital
Frequently Asked Questions
Who can join the NCT05766410 clinical trial?
This trial is open to female participants only, aged 20 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05766410 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05766410 currently recruiting?
Yes, NCT05766410 is actively recruiting participants. Contact the research team at yslu@ntu.edu.tw for enrollment information.
Where is the NCT05766410 trial being conducted?
This trial is being conducted at Taipei, Taiwan, Taipei, Taiwan.
Who is sponsoring the NCT05766410 clinical trial?
NCT05766410 is sponsored by National Taiwan University Hospital. The principal investigator is Yen-Shen Lu, MD, PhD at National Taiwan University Hospital. The trial plans to enroll 60 participants.
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