the Efficacy of Leucogen in Preventing the Risk of Ribociclib-Associated Neutropenia in Early Breast Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Podpisana i datowana zgoda na uczestnictwo w badaniu
- •Wiek powyżej 18 lat w momencie podpisania zgody
- •Kobieta w okresie menopauzy (potwierdzonym przez wiek, zabiegi chirurgiczne lub testy hormonalne)
- •Potwierdzona histologicznie inwazyjna rak piersi, zdiagnozowana nie wcześniej niż 18 miesięcy przed zapisem
- •Rak czuły na hormony - dodatni receptor estrogenowy i/lub progesteronowy
- •Rak bez białka HER2 (potwierdzone badaniem laboratoryjnym)
- •Chirurgiczne usunięcie całego guza z czystymi brzegami, stadium II lub III
- •Gotowość do przyjmowania hormonalnej terapii uzupełniającej przez co najmniej 5 lat
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- April 30, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Breast surgery department
Hangzhou, China
Trial contact
Jing xin Jiang, Doctor
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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