Culmerciclib in HR+/HER2+ Advanced 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 is a phase II, multicenter, open-label, single-arm clinical study. The purpose of this study is to evaluate the efficacy and safety of culmerciclib combined with anti-HER2 targeted therapy and endocrine therapy as maintenance treatment in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer. Culmerciclib is a novel oral cyclin-dependent kinase 2/4/6 (CDK2/4/6) inhibitor. It has been approved in China for use in combination with fulvestrant in patients with HR-positive, HER2-negative advanced breast cancer who have progressed on prior endocrine therapy. Patients enrolled in this study will receive culmerciclib at a stepwise escalating dose of 120 mg, 150 mg, and 180 mg once daily, in combination with anti-HER2 therapy (trastuzumab with or without pertuzumab) and physician-selected endocrine therapy. Treatment will continue until disease progression, unacceptable toxicity, death, withdrawal of consent, or loss to follow-up. The primary endpoint is progression-free survival. Secondary endpoints include objective response rate, disease control rate, clinical benefit rate, overall survival, and safety.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Kobiety w wieku 18 lat i starsze z potwierdzonym rozsianym lub zaawansowanym, nieoperacyjnym rakiem piersi.
- •Rak piersi, który reaguje na hormony i ma cechę HER2. W tym przypadku, co najmniej 10% komórek rakowych reaguje na hormony (estrogen), a marker HER2 jest dodatni (3+ w badaniu IHC lub 2+ z potwierdzeniem przez FISH).
- •Pacjentki, u których można pobrać próbkę guza do analizy.
- •Pacjentki z przerzutami do mózgu, które nie mają objawów lub objawy są kontrolowane.
- •Można wcześniej mieć za sobą leczenie (radioterapię, chemioterapię, terapię anty-HER2) w leczeniu uzupełniającym lub przedoperacyjnym.
- •Ogólny stan zdrowia pacjentki pozwala na uczestnictwo w badaniu (w skali ECOG 0-1).
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 29, 2026
- Sex
- Female only
Therapies / drugs in trial
Locations (1)
Sun yat-Sen University Cancer Center
Guangzhou, China
Trial contact
Meiting Chen, Doctor
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/31/2026.
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