Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer

The First Affiliated Hospital with Nanjing Medical University1 site in 1 country1,163 target enrollmentNovember 17, 2023

ConditionsEarly Breast Cancer

InterventionsDalpiciclib Endocrine therapy

DrugsDalpiciclib Endocrine therapy

Overview

Phase: Phase 2
Intervention: Dalpiciclib
Conditions: Early Breast Cancer
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Enrollment: 1163
Locations: 1
Primary Endpoint: invasive Disease-free Survival (iDFS)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive, HER2-negative Early Breast Cancer.

Registry

clinicaltrials.gov

Start Date

November 17, 2023

End Date

June 2029

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Responsible Party

Principal Investigator

Liu Xiaoan

Professor

The First Affiliated Hospital with Nanjing Medical University

Eligibility Criteria

Inclusion Criteria

•Patient is ≥ 18 years-old
•Patient is female with known menopausal status (postmenopausal or premenopausal/perimenopause)
•Patient with histologically confirmed HR+/HER2- early breast cancer (immunohistochemical ER and/or PR≥10%)
•Histologically confirmed invasive breast cancer with anatomic stages of IIA-IIIC stage (T2-4N0-3M0), of which stage IIA only included T1N1M0
•Patients with or without neoadjuvant or adjuvant chemotherapy/ radiotherapy were eligible for inclusion
•From operation to enrollment should not exceed 12 months
•Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria

•metastatic disease (Stage IV) or inflammatory breast cancer
•Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
•Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
•A history of allergy to the drugs in this study；
•Unable or unwilling to swallow tablets
•History of gastrointestinal disease with diarrhea as the major symptom.

Arms & Interventions

Treatment

Dalpiciclib and endocrine therapy

Intervention: Dalpiciclib

Treatment

Dalpiciclib and endocrine therapy

Intervention: Endocrine therapy

Outcomes

Primary Outcomes

invasive Disease-free Survival (iDFS)

Time Frame: From enrollment until time of events up to 3 years

Invasive disease-free survival time is defined as the time from date of enrollment until the first disease recurrence or death from any cause

Secondary Outcomes

Disease-free Survival (DFS)(From enrollment until time of events up to 3 years)
AEs and SAEs(From the first administration to one months after the last drug administration，up to one month)