Efficacy and Safety of Culmerciclib Plus Aromatase Inhibitors in a Response-Adapted Neoadjuvant Strategy for Highly Proliferative ER-Positive/HER2-Negative 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 prospective, response-adapted phase II study evaluates the efficacy and safety of neoadjuvant culmerciclib in combination with aromatase inhibitors in patients with highly proliferative ER-positive/HER2-negative breast cancer. All patients initially receive induction treatment with culmerciclib plus endocrine therapy, followed by on-treatment assessment of biological and clinical response. Patients demonstrating an adequate response continue the same regimen, whereas those with a suboptimal response are transitioned to alternative treatment strategies prior to surgery. This adaptive approach aims to optimize treatment selection, improve therapeutic efficacy, and avoid unnecessary exposure to ineffective therapy.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Kobiety w wieku 18-75 lat.
- •Rak piersi z obecnymi receptorami estrogenowymi (ER) i bez raka HER2.
- •Szybko rozwijający się rak (wskaźnik Ki-67 co najmniej 20%).
- •Rak piersi we wczesnym stadium (I-IIIA), niezdiagnozowany wcześniej i bez leczenia.
- •Dobry ogólny stan zdrowia (skala ECOG 0-1).
- •Odpowiednia ilość komórek krwi i płytek krwi.
- •Prawidłowe wyniki badań wątroby i nerek.
- •Chęć i możliwość wykonania biopsji guza oraz podpisania zgody.
✗ Disqualifies
- •Wcześniejsze leczenie raka (chemioterapia, radioterapia, inne leki).
- •Rak piersi w stadium IV.
- •Obustronny rak piersi, rak zapalny lub rak nieujawniony.
- •Inne poważne choroby nowotworowe w ciągu ostatnich 5 lat (poza niektórymi przypadkami raka szyjki macicy).
- •Poważne problemy z sercem, wątrobą lub nerkami.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- June 1, 2026
- Sex
- Female only
Therapies / drugs in trial
Locations (1)
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, China
Trial contact
Yunxiang Zhou
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.