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Trial Title:
Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer
NCT ID:
NCT06341894
Condition:
Early Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Dalpiciclib
Description:
CDK4/6 inhibitor dalpiciclib, 100mg orally qd
Arm group label:
Treatment
Other name:
CDK4/6 inhibitor
Intervention type:
Drug
Intervention name:
Endocrine therapy
Description:
Fulvestrant/AI
Arm group label:
Treatment
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Nanjing Medical University
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoan Liu, Professor
Phone:
025-68308162
Email:
liuxiaoan@126.com
Start date:
November 17, 2023
Completion date:
June 2029
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06341894
