NEOadjuvant Abemaciclib and GIredestrant triaL in Patients With ER-positive, HER2-negative Early Breast Cancer — Neo-AGILE  

Breast Cancer Clinical Trial

Official title: NEOadjuvant Abemaciclib and GIredestrant triaL in Patients With ER-positive, HER2-negative Early Breast Cancer

Status Not yet recruiting

Clinical Trial Summary

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

Clinical Trial Description

This is a phase II, multicentre, single-arm neoadjuvant study in post- menopausal women with ER-positive and HER2-previously untreated early BC. The trial will include approximately 10 sites in Italy.

The study plan will include a maximum 28-day screening period prior to start treatment. During the 6 cycles of the on-study intervention period, participants will return to the clinic every 2 weeks (14 ± 3 days) for the first 2 cycles, and then on Day 1 of the subsequent 4 cycles.

Surgery should be performed as soon as possible after at least 7 days, from the last dose of abemaciclib and giredestrant, and no later than 30 days.

During the short-term follow-up, participants should return for an in-clinic visit 28 days (± 5 days) after surgery. After the short-term follow-up visit, all participants will enter the long-term follow-up period, which will begin the day after the short-term follow-up visit and will continue up to Year1. Visits during the long-term follow-up visits should occur approximately every 3 months for a total of one year. For participants who are unable to attend the required clinic visits, long-term follow-up visits can take place as a phone visit.

Blood and tumor samples will be used to investigate the mechanisms of response and resistance to therapy in ER+ and HER2- early BC. For each patient enrolled in the present study, blood samples (mandatory) and tumor biopsies (mandatory) are required and collected at entry in the study, following 14 days and 12 weeks of treatment, and prior to or during surgery. Blood samples are also required to be collected at the short follow up visit, at the end of the long follow-up period after on year (± 28 days) from the last short follow-up visit and at disease progression (suggested but not mandatory). ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT06259929
• Study type: Interventional
• Source: Fondazione Oncotech
• Contact: Michelino De Laurentiis, MD
• Phone: 08117770442
• Email: m.delaurentiis@istitutotumori.na.it
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 1, 2024
• Completion date: April 1, 2027