the Efficacy of Leucogen in Preventing the Risk of Ribociclib-Associated Neutropenia in Early Bre… (NCT07380646) | Clinical Trial Compass
RecruitingPhase 2
the Efficacy of Leucogen in Preventing the Risk of Ribociclib-Associated Neutropenia in Early Breast Cancer
China94 participantsStarted 2026-01-07
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. The patient has signed and dated the informed consent form.
✓. Age \> 18 years at the time of signing informed consent.
✓. The patient is a female with known menopausal status at the time of signing informed consent or initiation of adjuvant endocrine therapy (whichever is earlier). Postmenopausal status is defined as: bilateral oophorectomy, age \> 60 years, or age \< 60 years with amenorrhea ≥ 12 months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression), and follicle-stimulating hormone and plasma estradiol levels within the local postmenopausal normal range.
✓. Histologically confirmed unilateral primary invasive breast cancer, with the date of initial cytological or histological diagnosis within 18 months before enrollment. Patients with multicentric and/or multifocal tumors are eligible if all pathologically examined lesions meet criteria 5 and 6 below.
✓. Estrogen receptor (ER) and/or progesterone receptor (PgR) positivity in the breast cancer, based on the most recent analyzed tissue sample from the local laboratory.
✓. HER2-negative breast cancer, defined as negative by in situ hybridization or immunohistochemistry (IHC) status of 0 or 1+. If IHC is 2+, a negative in situ hybridization result is required to confirm HER2-negative status (based on the most recent analyzed tissue sample from the local laboratory).
✓
What they're measuring
1
incidence of severe neutropenia
Timeframe: From enrollment to the end of treatment at 16 weeks
Trial details
NCT IDNCT07380646
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
. The patient has undergone surgical resection with complete tumor removal, negative microscopic margins on the final surgical specimen, and belongs to one of the following categories:
✓. If clinically indicated, the patient has completed adjuvant and/or neoadjuvant chemotherapy according to guidelines before screening.
Exclusion criteria
✕. Previous treatment with any CDK4/6 inhibitor.
✕. Use of tamoxifen, raloxifene, or aromatase inhibitors for breast cancer risk reduction ("chemoprevention") and/or osteoporosis treatment within 2 years before signing informed consent.
✕. Prior anthracycline cumulative dose reaching or exceeding: doxorubicin 450 mg/m², or epirubicin 900 mg/m².
✕. Known hypersensitivity to any excipient of ribociclib and/or the endocrine therapy and/or leucogen (e.g., rare hereditary galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, or soy allergy).
✕. Evidence of distant metastasis of breast cancer beyond regional lymph nodes (AJCC 8th edition Stage IV) and/or recurrence after curative surgery.
✕. Concurrent use of other anticancer therapies, except adjuvant endocrine therapy.
✕. Major surgery, chemotherapy, or radiotherapy within 14 days before enrollment.
✕. Clinical and laboratory acute toxicities related to prior anticancer therapy have not recovered to Grade 1 or lower (per NCI CTCAE version 4.03) on the day of enrollment. Exceptions: alopecia and amenorrhea of any grade are allowed.