Condition: Breast Cancer · Sponsor: Fondazione Oncotech
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
This description comes directly from the study's public registry record.
Michelino De Laurentiis, MD · 08117770442 · m.delaurentiis@istitutotumori.na.it
Claudia Von Arx, MD · 0815903565 · Claudia.vonarx@istitutotumori.na.it
Always discuss trial participation with your own doctor first.
| Humanitas Istituto Clinico Catanese | Catania, Catania, Italy | Not Yet Recruiting |
| IRCCS Ospedale Policlinico San Martino | Genova, Genova, Italy | Not Yet Recruiting |
| AOU Federico II | Naples, Napoli, Italy | Not Yet Recruiting |
| Istituto Nazionale Tumori "G. Pascale" | Naples, Napoli, Italy | Recruiting |
| Istituto Oncologico Veneto IRCCS | Padova, Padova, Italy | Not Yet Recruiting |
| IRCCS Centro di Riferimento Oncologico (CRO) | Aviano, PN, Italy | Not Yet Recruiting |
| Fondazione Universitaria Policlinico Gemelli IRCCS | Roma, Roma, Italy | Not Yet Recruiting |
| Ospedale Fatebenefratelli - Isola Tiberina | Roma, Roma, Italy | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT06259929