Actively Recruiting
the Efficacy of Leucogen in Preventing the Risk of Ribociclib-Associated Neutropenia in Early Breast Cancer
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-04-30
94
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, single-arm, open-label Phase II exploratory clinical trial designed to evaluate whether prophylactic use of leucogen can reduce the incidence of Grade 3 or higher neutropenia in early-stage HR+/HER2- breast cancer patients receiving ribociclib combined with endocrine therapy. The study plans to enroll 97 patients using a Simon two-stage design, with the primary endpoint being the incidence of severe neutropenia within 4 treatment cycles (4 months) after initiation. Secondary endpoints include the incidence of all-grade neutropenia, febrile neutropenia, ribociclib treatment intensity, and safety. The study will systematically assess the preventive efficacy and safety of leucogen to provide a basis for subsequent Phase III randomized controlled trials.
CONDITIONS
Official Title
the Efficacy of Leucogen in Preventing the Risk of Ribociclib-Associated Neutropenia in Early Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Age over 18 years at consent
- Female with known menopausal status before starting endocrine therapy
- Histologically confirmed unilateral primary invasive breast cancer diagnosed within 18 months
- Estrogen and/or progesterone receptor positive breast cancer
- HER2-negative breast cancer confirmed by local lab tests
- Completed surgical tumor removal with negative margins and meets specified cancer stages and risk criteria
- Completed chemotherapy and/or radiotherapy if clinically indicated before screening
- No contraindications to planned endocrine therapy for at least 5 years
- Enrollment within 12 months of starting neoadjuvant endocrine therapy if received
- ECOG Performance Status of 0 or 1
- Adequate bone marrow and organ function per local lab values
- Normal or corrected levels of sodium, potassium, magnesium, and calcium
- Electrocardiogram with QTcF interval less than 450 ms and heart rate 50-90 bpm
- Willing and able to follow visits, treatments, lab tests, and trial procedures
- Negative pregnancy test for females of childbearing potential within 14 days before enrollment
- Use of highly effective contraception during the trial and for 21 days after treatment
You will not qualify if you...
- Prior treatment with any CDK4/6 inhibitor
- Use of tamoxifen, raloxifene, or aromatase inhibitors for breast cancer risk reduction or osteoporosis treatment within 2 years
- Prior anthracycline dose exceeding specified limits
- Known allergy to ribociclib, endocrine therapy, or leucogen components
- Evidence of breast cancer metastasis beyond regional lymph nodes or recurrence after surgery
- Concurrent anticancer therapies other than endocrine therapy
- Major surgery, chemotherapy, or radiotherapy within 14 days before enrollment
- Unresolved acute toxicities from prior cancer treatments above Grade 1 except alopecia and amenorrhea
- Current invasive cancer or recent invasive cancer treatment within 2 years
- Known HIV infection
- Active hepatitis B or C infection
- Significant uncontrolled heart disease or abnormalities including recent heart attack, cardiomyopathy, or arrhythmias
- Use of medications or supplements affecting CYP3A4/5 within 7 days before enrollment
- Recent systemic corticosteroid or immunomodulator use within specified timelines
- Gastrointestinal conditions affecting drug absorption
- Other severe uncontrolled medical conditions posing safety risks
- Participation in other interventional studies within 30 days or longer as specified
- Low white blood cell or neutrophil count within 1 week before starting ribociclib
- Pregnancy, lactation, or plans to breastfeed during the study period
AI-Screening
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Trial Site Locations
Total: 1 location
1
Breast surgery department
Hangzhou, Zhejiang, China, 310058
Actively Recruiting
Research Team
J
Jing xin Jiang, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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