RecruitingPhase 2NCT06259929

NEOadjuvant Abemaciclib and GIredestrant TriaL in Patients with ER-positive, HER2-negative Early Breast Cancer

Sponsor

Fondazione Oncotech

Enrollment

51 participants

Start Date

Jan 27, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — abemaciclib (a CDK4/6 inhibitor) and giredestrant (a newer estrogen blocker) — given before surgery in postmenopausal women with hormone receptor-positive, HER2-negative early breast cancer. The goal is to shrink the cancer before removal and assess response. **You may be eligible if...** - You are a postmenopausal woman 18 or older - You have hormone receptor-positive (ER ≥10%), HER2-negative breast cancer - Your tumor is at least 1 cm in size - You have not yet received any treatment for this cancer - You are considered a good candidate for hormone-based (endocrine) therapy - Your tumor has a high enough proliferation marker (Ki67 ≥10%) **You may NOT be eligible if...** - You are premenopausal - You have already started chemotherapy, hormone therapy, surgery, or radiation for this cancer - Your breast cancer is HER2-positive or hormone receptor-negative - You have another active cancer - You have significant liver, heart, or blood count problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAbemaciclib 150 MG + Giredestrant 30 MG

Enrolled patients will receive 6 cycles of treatment in the absence of disease progression or unacceptable toxicity for a total of 24 weeks (2 weeks of opportunity phase and 22 weeks of neoadjuvant phase) before surgery