RecruitingPhase 2NCT06341894

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

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

1,163 participants

Start Date

Nov 17, 2023

Study Type

INTERVENTIONAL

Conditions

Early Breast Cancer

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

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

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 Criteria6

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.