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

NCT06259929 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-02-18

No results posted yet for this study

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

Conditions

Interventions

DRUG

Abemaciclib 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

Sponsors & Collaborators

  • Fondazione Oncotech

    lead OTHER

Principal Investigators

  • Michelino De Laurentiis, MD · National Cancer Institute, Naples

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-27
Primary Completion
2026-04-01
Completion
2027-04-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06259929 on ClinicalTrials.gov