OncoMatch/Clinical Trials/NCT05837455
NeoTAILOR: ABiomarker-directed Approach to Guide Neoadjuvant Therapy for Patients With Stage II/III ER-positive, HER2-negative Breast Cancer
Is NCT05837455 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for breast cancer.
Treatment: 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 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (ER > 10%)
ER-positive (ER > 10%)
Required: HER2 (ERBB2) negative (IHC 0 or 1+ or FISH negative)
HER2 negative must be assessed by FISH or IHC staining 0 or 1+ according to ASCO/CAP guidelines
Disease stage
Required: Stage II, III (AJCC 8th edition)
Excluded: Stage CT4D, CM1
clinical stage II or III (by AJCC 8th edition - at least T2, any N, M0 or if N1+ then any T)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Lab requirements
Blood counts
Adequate bone marrow function, as determined by the treating physician
Kidney function
Adequate organ function, as determined by the treating physician
Liver function
Adequate organ function, as determined by the treating physician
Adequate bone marrow and organ function, as determined by the treating physician
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Washington University School of Medicine · St Louis, Missouri
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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