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

Nanjing Medical University

Status and phase

Enrolling

Phase 2

Conditions

Early Breast Cancer

Treatments

Drug: Endocrine therapy

Drug: Dalpiciclib

Study type

Interventional

Funder types

Other

Identifiers

NCT06341894

OBU-II-BC-126

Details and patient eligibility

About

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.

Enrollment

1,163 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No 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.