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

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.

Trial Details

NCT ID
NCT05837455
Phase
PHASE2
Sponsor
Washington University School of Medicine
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • VENTANA MIB-1 Ki67 assay
  • Oncotype DX® Recurrence Score
  • PAM50-based Prosigna breast cancer gene signature assay
  • Anastrozole
  • Combination anthracycline and/or taxane based treatment
Locations (sample)
  • St Louis, Missouri, United States|38.62727,-90.19789

Key Eligibility Criteria

  • Histologically or cytologically confirmed newly diagnosed clinical stage II or III (by AJCC 8th edition - at least T2, any N, M0 or if N1+ then any…
  • HER2 negative must be assessed by FISH or IHC staining 0 or 1+ according to ASCO/CAP guidelines.
  • A palpable mass is not required; however, tumor size must be either:
  • ≥2 cm in one dimension by clinical or radiographic examination (WHO criteria), if clinically axillary lymph node negative OR

For full eligibility, visit ClinicalTrials.gov.

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