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Pragmatic Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2- Early Breast Cancer Using Oncotype DX and Abemaciclib

NCT07428018 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-03-05

No results posted yet for this study

Summary

This is a pragmatic phase 2 study to determine the proportion of patients with ER+ (≥10%)/HER2- EBC in whom neoadjuvant chemotherapy can be replaced by NET plus abemaciclib based on the results of the ODX RS obtained in the initial diagnostic biopsy and according to the MDT decision and to evaluate the proportion of patients undergoing breast conservative surgery and/or sentinel node biopsy

Conditions

  • Breast Cancer
  • HER2 + Breast Cancer
  • HR Positive
  • Neoadjuvant Therapy

Interventions

DRUG

Abemaciclib

neoadjuvant endocrine therapy (NET) plus abemaciclib

Sponsors & Collaborators

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    collaborator OTHER

  • Humanitas Research Hospital IRCCS, Rozzano-Milan

    collaborator OTHER

  • IRCCS San Raffaele

    collaborator OTHER

  • IEO Foundation

    collaborator UNKNOWN

  • Papa Giovanni XXIII Hospital

    collaborator OTHER

  • Mario Negri Institute for Pharmacological Research

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2029-04-30
Completion
2029-04-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
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 NCT07428018 on ClinicalTrials.gov