NCT05512416

Brief Summary

In this single arm, open label, phase 2 trial, operable patients with stage IIB-III HR+/HER2- breast cancer will be enrolled and receive six cycles of adjuvant dalpiciclib plus letrozole. This study aims to assessed the biological effects and safety of dalpiciclib in combination with letrozole for HR+/HER2- breast cancer in the neoadjuvant setting.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Aug 2022

Shorter than P25 for phase_2 breast-cancer

Status
unknown

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 Start

First participant enrolled

August 1, 2022

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 23, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

1 year

First QC Date

August 18, 2022

Last Update Submit

August 21, 2022

Conditions

Breast Cancer

Keywords

breast cancerCDK4/6 inhibitorendocrine therapyhormone receptor-positivedalpiciclibletrozole

Outcome Measures

Primary Outcomes (1)

  • Complete cell-cycle arrest at C1D15, defined as ki67≤2.7%

    From the date into this study(signed ICF) to C1D15,defined as ki67≤2.7%

    up 2 years

Secondary Outcomes (7)

  • residual cancer burden

    up 2 years

  • objective response rate

    up 2 years

  • change in Ki67 from baseline to 2 weeks of treatment

    up 2 years

  • preoperative endocrine prognostic index

    up 2 years

  • pathologic complete response

    up 2 years

  • +2 more secondary outcomes

Study Arms (1)

cohort 1

EXPERIMENTAL

patients with stage IIB-III HR+/HER2- breast cancer

Drug: dalpiciclib plus letrozole

Interventions

dalpiciclib plus letrozoleDRUG

Six 4-week cycles of dalpiciclib orally, 150mg, day 1-21, and letrozole orally, 2.5 mg, day 1-28

Also known as: D+L
cohort 1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

dalpiciclibLetrozole

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2022

First Posted

August 23, 2022

Study Start

August 1, 2022

Primary Completion

August 1, 2023

Study Completion

May 1, 2024

Last Updated

August 23, 2022

Record last verified: 2022-08