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 (Jun 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
Treatments studied
Endocrine / hormonal
Other
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)
Demographics
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 →Frequently asked questions
Is NCT05837455 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ESR1?
Yes, ESR1 overexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
What disease stage is eligible?
Stage II or III is required.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages