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RECRUITINGPHASE2

Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer

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

NCT06341894•The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

FEMALE

Healthy Volunteers

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.

Locations (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Key Dates

Start Date

November 17, 2023

Primary Completion Date

June 1, 2027

Completion Date

June 1, 2029

Last Updated

April 2, 2024

Enrollment

1,163

ESTIMATED participants

Conditions

Early Breast Cancer

Interventions

Dalpiciclib

DRUG

Endocrine therapy

DRUG

Contacts

Xiaoan Liu, Professor

CONTACT

025-68308162 liuxiaoan@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 2, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer

Inclusion Criteria

Exclusion Criteria

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