NEOadjuvant Abemaciclib and GIredestrant triaL in patients with ER-positive, HER2-negative Early breast cancer

Conditions

ER-positive, HER2-negative Early breast cancer

Brief summary

CCCA rate, defined as the proportion of patients with centrally assessed Ki67 scores ≤ 2.7% in stained biopsies upon treatment at Week 2

Detailed description

Percent change in Ki67 expression from baseline to Week 2, ROR score reduction (from baseline to Week 2 and surgery), Clinical and radiologic (magnetic resonance imaging [MRI]) objective responses, Safety endpoints: adverse events and toxicities, according to CTCAE v5.0, also resulting from laboratory tests, vital signs, ECG, ECOG performance status and physical examination, Mechanisms of response and resistance to therapy (translational plan), Correlation between Ki-67% reduction and 18-Fluorothymidine (FLT) uptake reduction, Pathological complete response (pCR) rate (ypT0/is, ypN0) of giredestrant plus abemaciclib

Claudia von Arx, Alessandra Calabrese, R. Caputo, Vincenzo Di Lauro, M. Pensabene et al. (14 authors)

ESMO Open2024-05-01

10.1016/j.esmoop.2024.103145

Interventions

DRUGABEMACICLIB

DRUGRO7197597

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
CCCA rate, defined as the proportion of patients with centrally assessed Ki67 scores ≤ 2.7% in stained biopsies upon treatment at Week 2	—

Secondary

Measure	Time frame
Percent change in Ki67 expression from baseline to Week 2, ROR score reduction (from baseline to Week 2 and surgery), Clinical and radiologic (magnetic resonance imaging [MRI]) objective responses, Safety endpoints: adverse events and toxicities, according to CTCAE v5.0, also resulting from laboratory tests, vital signs, ECG, ECOG performance status and physical examination, Mechanisms of response and resistance to therapy (translational plan), Correlation between Ki-67% reduction and 18-Fluorothymidine (FLT) uptake reduction, Pathological complete response (pCR) rate (ypT0/is, ypN0) of giredestrant plus abemaciclib	—

Measure

Time frame

Percent change in Ki67 expression from baseline to Week 2, ROR score reduction (from baseline to Week 2 and surgery), Clinical and radiologic (magnetic resonance imaging [MRI]) objective responses, Safety endpoints: adverse events and toxicities, according to CTCAE v5.0, also resulting from laboratory tests, vital signs, ECG, ECOG performance status and physical examination, Mechanisms of response and resistance to therapy (translational plan), Correlation between Ki-67% reduction and 18-Fluorothymidine (FLT) uptake reduction, Pathological complete response (pCR) rate (ypT0/is, ypN0) of giredestrant plus abemaciclib

—

Countries

Italy

Outcome results

None listed