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Clinical trial

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

ID
Name
OBU-II-BC-126
Description
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.
Trial arms
Trial start
2023-11-17
Estimated PCD
2027-06-01
Trial end
2029-06-01
Status
Recruiting
Phase
Early phase I
Treatment
Dalpiciclib
CDK4/6 inhibitor dalpiciclib, 100mg orally qd
Arms:
Treatment
Other names:
CDK4/6 inhibitor
Endocrine therapy
Fulvestrant/AI
Arms:
Treatment
Size
1163
Primary endpoint
invasive Disease-free Survival (iDFS)
From enrollment until time of events up to 3 years
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1163, 'type': 'ESTIMATED'}}
Updated at
2024-04-02

1 organization

2 products

1 indication

Organization
The First Affiliated Hospital with Nanjing Medical University
Product
Dalpiciclib
Indication
Early Breast Cancer
Product
Endocrine therapy