RecruitingBreast CancerCancer of the Breast
NeoTAILOR: ABiomarker-directed Approach to Guide Neoadjuvant Therapy for Patients With Stage II/III ER-positive, HER2-negative Breast Cancer
Eligible age
18+ yrs
Accepts
Women
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Washington University School of Medicine
You may qualify if…
- ✓ 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 T) ER-positive (ER \> 10%), any PR, and HER2-negative breast cancer with complete surgical excision of the breast cancer after neoadjuvant therapy as the treatment goal.
- ✓ 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
- ✓ Measureable (≥10 mm) by modified RECIST v1.1 for breast MRI (see Section 9.0), if histologically confirmed resectable locoregional nodal involvement.
- ✓ ECOG performance status 0 or 1.
- ✓ Eligible to receive neoadjuvant aromatase inhibitor, as per treating physician.
- ✓ Eligible to receive neoadjuvant standard of care anthracycline- and/or taxane-based chemotherapy regimen, as per treating physician.
You may not qualify if…
- ✕ Inflammatory breast cancer (cT4d disease as per AJCC 8th edition).
- ✕ Locally recurrent or metastatic disease (cM1 disease as per AJCC 8th edition).
- ✕ Bilateral breast cancer.
- ✕ Prior systemic therapy for the indexed breast cancer.
- ✕ Pre-existing Grade ≥2 neuropathy.
- ✕ Uncontrolled intercurrent illness that would limit compliance with study requirements.
- ✕ A history of other malignancy ≤5 years prior to the indexed breast cancer diagnosis with the following exceptions:
- ✕ Basal cell or squamous cell carcinoma of the skin which were treated with local resection only
Where it's recruiting
Missouri
St Louis
Source: ClinicalTrials.gov · NCT05837455 · last updated 2026-04-13