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
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of dalpiciclib combined with endocrine therapy for women with early hormone receptor-positive (HR+) and HER2-negative breast cancer. This phase 2, multicenter, randomized, open-label clinical study plans to enroll 2000 women, comparing two different doses and treatment durations of dalpiciclib alongside endocrine therapy. The study's goal is to understand how these treatments affect disease-free survival and overall outcomes in this patient group. Participants are randomly assigned to one of two groups: one receives 125 mg of dalpiciclib daily for 2 years, and the other receives 100 mg daily for 3 years. Both groups take the drug in 28-day cycles, with 21 days on treatment followed by 7 days off, alongside endocrine therapy drugs selected by the investigator such as aromatase inhibitors, fulvestrant, tamoxifen, or toremifene. Treatment continues until disease progression, unacceptable side effects, withdrawal, or investigator decision. During the study, participants will have regular assessments including evaluations every 3 months in the first year and every 6 months in the second and third years to monitor patient-reported outcomes. The primary outcome is 3-year invasive disease-free survival, with secondary outcomes including distant disease-free survival, overall survival, and safety monitoring up to 30 days after treatment ends. Participants will be closely followed to assess treatment effects and side effects throughout the study duration.
CONDITIONS
Brief 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, postmenopausal or premenopausal/perimenopausal
- Early-stage breast cancer with hormone receptor-positive and HER2-negative status confirmed by histology
- Clinical/pathological stages II-III invasive breast cancer
- For stage IIA, nodal involvement or high-risk tumor features required
- Patients may have received or not received neoadjuvant or adjuvant chemotherapy
- Surgery to enrollment interval no more than 12 months
- Recovery from acute effects of prior radiotherapy with at least 14 days washout
- Recovery from chemotherapy side effects except hair loss or grade 2 peripheral neuropathy, with at least 21 days washout
- ECOG performance status of 0-1
- Adequate organ function including blood counts, liver and kidney tests, and heart QT interval
- Voluntary informed consent with willingness to comply and follow up
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 simultaneously
- Recent blood transfusion or treatment with colony-stimulating factors
- Known allergy to study medication components
- History of immunodeficiency, organ transplantation, or positive HIV test
- History of significant heart disease including angina, arrhythmia, heart attack, or heart failure
- Pregnant or lactating women
- Any other condition deemed unsuitable by investigators
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years or up to 3 years depending on assigned dosage
Participants take Dalpiciclib combined with endocrine therapy. Dalpiciclib is taken daily for 21 days followed by 7 days off, in 28-day cycles. Treatment duration is up to 2 or 3 years depending on the assigned dosage.
Regular visits according to treatment cycles over the treatment period
Duration - Up to 30 days after completion of medication
Participants are followed for safety and effectiveness after treatment completion, including patient-reported outcomes and survival monitoring.
Assessments every 3 months in the first year and every half month in the second and third years
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
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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