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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05766410
Other study ID # 202207200MIPB
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 16, 2022
Est. completion date September 30, 2026

Study information

Verified date September 2022
Source National Taiwan University Hospital
Contact Yen-Shen Lu, MD, PhD
Phone +886-2-23123456
Email yslu@ntu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date September 30, 2026
Est. primary completion date September 30, 2025
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Palbociclib
CDK4, 6 inhibitor
Ribociclib
CDK4, 6 inhibitor
Abemaciclib
CDK4, 6 inhibitor
Letrozole
Endocrine therapy

Locations

Country Name City State
Taiwan Department of Oncology,National Taiwan University Hospital Taipei
Taiwan Department of Oncology, National Taiwan University Hospital Taipei City

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The expression of immune-related signature change after different CDK4/6 inhibitor treatments by RNAseq Characterization of RNAseq from serial tumor biopsy samples Through study completion, an average of 3 years
Secondary Adverse events According to CTCAE 4.03 4 months
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