Actively Recruiting
Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +/HER2- Breast Cancer: a Multicenter, Prospective Clinical Study
Led by Fujian Cancer Hospital · Updated on 2026-05-12
2000
Participants Needed
2
Research Sites
336 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, prospective, randomized, open-label clinical study to assess the efficacy and safety of endocrine combined with different doses and treatment duration of darisenatide adjuvant therapy in HR +/HER2- early breast cancer. The study planned to include 2000 HR +/HER2- early breast cancer patients who met the study criteria and were randomized in a 1:1 ratio to Column 1 and Column 2 stratified by nodal status (positive/negative), prior (neo) adjuvant chemotherapy (yes/no), and clinical/pathological stage (Stage II/III). Cohort 1 received dalcili 125 mg in combination with endocrine therapy for 2 years with dalcili; Cohort 2 received dalcili 100 mg in combination with endocrine therapy for 3 years with dalcili; treatment had to be discontinued until disease progression, intolerable adverse events, withdrawal of consent, or investigator judgment.
CONDITIONS
Official Title
Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +/HER2- Breast Cancer: a Multicenter, Prospective Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older
- Diagnosed with early-stage breast cancer that is hormone receptor positive and HER2 negative confirmed by histology
- Clinical or pathological stage II or III breast cancer, with specific criteria for stage IIA
- Patients may have received neoadjuvant or adjuvant chemotherapy
- Surgery to enrollment interval not exceeding 12 months
- Recovered from acute effects of radiotherapy with at least 14 days washout before enrollment
- Recovered from acute adverse effects of chemotherapy before enrollment, with at least 21 days washout since last chemotherapy
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate organ function including blood counts, liver and kidney function, and normal QTcF interval on ECG
- Willing and able to comply with study procedures and provide informed consent
You will not qualify if you...
- Stage IV, recurrent, metastatic, or inflammatory breast cancer
- History of any other malignant tumor or prior anti-tumor therapy except certain cured skin or cervical cancers
- Participation in other clinical trials at the same time
- Recent blood transfusion within 2 weeks or use of colony-stimulating factors
- Known allergy to study medication components
- History of immunodeficiency including HIV or organ transplantation
- History of significant heart disease including angina, arrhythmias, myocardial infarction, or heart failure
- Pregnancy or breastfeeding
- Any condition deemed by investigators to make participation unsuitable
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Fujian Cancer Hosptial
Fuzhou, Fujian, China, 350001
Actively Recruiting
2
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 618099
Not Yet Recruiting
Research Team
C
Chuangui Song, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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