NCT05766410

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
5mo left

Started Sep 2022

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Sep 2022Sep 2026

Study Start

First participant enrolled

September 16, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Expected
Last Updated

March 16, 2023

Status Verified

September 1, 2022

Enrollment Period

3 years

First QC Date

February 3, 2023

Last Update Submit

March 15, 2023

Conditions

Breast CancerHormone Receptor-positive Breast CancerHormone Therapy

Keywords

CDK4, 6 inhibitorNeoadjuvant therapyHormone therapyHormone Receptor-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Adverse events

    4 months

Study Arms (3)

Palbociclib/Letrozole

EXPERIMENTAL

CDK4, 6 inhibitor and endocrine therapy

Drug: PalbociclibDrug: Letrozole

Ribociclib/Letrozole

ACTIVE COMPARATOR

CDK4, 6 inhibitor and endocrine therapy

Drug: RibociclibDrug: Letrozole

Abemaciclib/Letrozole

ACTIVE COMPARATOR

CDK4, 6 inhibitor and endocrine therapy

Drug: AbemaciclibDrug: Letrozole

Interventions

PalbociclibDRUG

CDK4, 6 inhibitor

Also known as: Ibrance
Palbociclib/Letrozole
RibociclibDRUG

CDK4, 6 inhibitor

Also known as: Kisqali
Ribociclib/Letrozole
AbemaciclibDRUG

CDK4, 6 inhibitor

Also known as: Venizio
Abemaciclib/Letrozole
LetrozoleDRUG

Endocrine therapy

Also known as: Femara
Abemaciclib/LetrozolePalbociclib/LetrozoleRibociclib/Letrozole

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Oncology, National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Department of Oncology,National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclibribociclibabemaciclibLetrozole

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Yen-Shen Lu, MD, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yen-Shen Lu, MD, PhD

CONTACT

+886-2-23123456yslu@ntu.edu.tw

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2023

First Posted

March 13, 2023

Study Start

September 16, 2022

Primary Completion

September 30, 2025

Study Completion (Estimated)

September 30, 2026

Last Updated

March 16, 2023

Record last verified: 2022-09

Locations

TW(2)