Plain-English translation of NCT07380646 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.
This trial is testing whether Leucogen, a medication taken by mouth, can prevent a common and serious side effect called severe low white blood cell count in women receiving ribociclib (a cancer-fighting drug) combined with hormone therapy for early-stage breast cancer. Ribociclib is effective at treating this type of breast cancer, but it can lower white blood cell counts, which weakens the immune system. This study wants to see if taking the preventive medication alongside ribociclib can keep white blood cells at safer levels.
Ribociclib is an effective treatment for early-stage hormone-responsive breast cancer, but many patients experience dangerously low white blood cell counts while taking it. This trial exists to find out whether this preventive medication can reduce that serious side effect, which would allow more patients to stay on their cancer treatment without interruption or dose reduction.
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You will take ribociclib by mouth once daily on days 1–21 of each 28-day treatment cycle, along with your regular hormone therapy medication (such as letrozole or anastrozole). You will also take the preventive medication Leucogen by mouth three times daily on days 8–28 of each cycle. Over the first 4 months (4 treatment cycles), you will have regular blood tests to monitor your white blood cell counts and check for side effects. The study involves multiple hospital visits across different medical centers to track your response to the combination treatment.
AI-generated summary from trial data · Jun 24, 2026 · Not medical advice
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