NeoTAILOR: ABiomarker-directed Approach to Guide Neoadjuvant Therapy for Patients With Stage II/III ER-positive, HER2-negative Breast Cancer

Breast Cancer Clinical Trial

Official title: NeoTAILOR: A Phase II Biomarker-directed Approach to Guide Neoadjuvant Therapy for Patients With Stage II/III ER-positive, HER2-negative Breast Cancer

Status Recruiting

Clinical Trial Summary

This study aims to utilize a novel biomarker-driven approach to guide neoadjuvant treatment selection. It is the hypothesis that this will improve clinical response for postmenopausal women with clinical stage II/III ER-positive, HER2-negative breast cancer and identify those who may not require neoadjuvant chemotherapy, with a primary focus on outcomes in Black patients.

Clinical Trial Description

Risk category is defined as follows:

• Low risk:

• Baseline Ki67 ≤ 10% (OR)

• Luminal A molecular intrinsic subtype by PAM50

• High risk:

• Non-Luminal A molecular intrinsic subtype by PAM50 (OR)

• In cases of non-diagnostic PAM50 molecular intrinsic subtype, patients will enroll in the high-risk group and undergo Week 4 tumor biopsy. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer of the Breast

• NCT number: NCT05837455
• Study type: Interventional
• Source: Washington University School of Medicine
• Contact: Nusayba A Bagegni, M.D.
• Phone: 314-273-3022
• Email: nbagegni@wustl.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: May 30, 2024
• Completion date: November 30, 2027