NEOadjuvant Abemaciclib and GIredestrant TriaL in Patients with ER-positive, HER2-negative 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
The objective of the study is to evaluate the efficacy and the safety of abemaciclib and giredestrant before surgery in participants with early stage, oestrogen receptor-positive (ER+), human epidermal receptor 2 negative (HER2-) breast cancer (BC). Primary objective: ● To evaluate the efficacy of abemaciclib and giredestrant in complete cell cycle arrest (CCCA) rate at Week 2. Secondary objectives: * To evaluate the efficacy of abemaciclib and giredestrant in reducing the relative Ki67 expression from baseline to Week 2 * To evaluate the efficacy of abemaciclib and giredestrant in risk of recurrence (ROR) score reduction, clinical and radiological tumor response; * To evaluate the safety of abemaciclib and giredestrant. Exploratory objectives: * To evaluate the mechanisms of response and resistance to therapy; * To evaluate the correlation between Ki-67% reduction and 18- Fluorothymidine (FLT) uptake reduction; * To evaluate the pathological complete response (pCR) rate (ypT0/is, ypN0) of giredestrant plus abemaciclib
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Kobieta powyżej 18 lat, która może wyrazić pisemną zgodę na udział w badaniu
- •Kobieta po menopauzie (potwierdzzona brakiem miesiączki przez co najmniej 12 miesięcy lub poprzez usunięcie obu jajników)
- •Nowotwór piersi o wymiarach co najmniej 1 cm, który można zmierzyć ultrasonografią
- •Potwierdzony ER-dodatni nowotwór (receptor estrogenowy dodatni) w co najmniej 10% komórek
- •Potwierdzony HER2-ujemny nowotwór (brak białka HER2)
- •Wysoki wskaźnik Ki67 (co najmniej 10%)
- •Brak wcześniejszego leczenia tego nowotworu chemioterapią, hormonami, operacją lub promieniowaniem
- •Wystarczająca funkcja nerek, wątroby i szpiku kostnego do bezpiecznego stosowania badanego leku
✗ Disqualifies
- •Nowotwór w obu piersiach
- •Przerzuty nowotworu na inne części ciała
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- February 18, 2025
- Sex
- Female only
Therapies / drugs in trial
Locations (8)
Humanitas Istituto Clinico Catanese
Catania, Italy
IRCCS Ospedale Policlinico San Martino
Genova, Italy
AOU Federico II
Naples, Italy
Istituto Nazionale Tumori "G. Pascale"
Naples, Italy
Istituto Oncologico Veneto IRCCS
Padova, Italy
IRCCS Centro di Riferimento Oncologico (CRO)
Aviano, Italy
Fondazione Universitaria Policlinico Gemelli IRCCS
Roma, Italy
Ospedale Fatebenefratelli - Isola Tiberina
Roma, Italy
Trial contact
Michelino De Laurentiis, MD
Claudia Von Arx, MD
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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