Actively Recruiting
NeoTAILOR: ABiomarker-directed Approach to Guide Neoadjuvant Therapy for Patients With Stage II/III ER-positive, HER2-negative Breast Cancer
Led by Washington University School of Medicine · Updated on 2026-04-13
81
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
S
Swim Across America
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
NeoTAILOR: ABiomarker-directed Approach to Guide Neoadjuvant Therapy for Patients With Stage II/III ER-positive, HER2-negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed newly diagnosed clinical stage II or III ER-positive (ER > 10%), any PR, and HER2-negative breast cancer
- HER2 negative confirmed by FISH or IHC 0 or 1+ per ASCO/CAP guidelines
- Tumor size at least 2 cm by clinical or radiographic exam if no lymph node involvement, or measurable (≥10 mm) by breast MRI if lymph nodes involved
- ECOG performance status 0 or 1
- Eligible to receive neoadjuvant aromatase inhibitor and standard anthracycline and/or taxane chemotherapy as per physician
- Able to tolerate breast MRI with intravenous contrast and complete MRI screening form
- Adequate bone marrow and organ function
- History of hepatitis C infection allowed if treated and cured
- At least 18 years old
- Postmenopausal status by age or surgical history
- Willing and able to sign informed consent and comply with study visits and treatment
You will not qualify if you...
- Inflammatory breast cancer (cT4d)
- Locally recurrent or metastatic breast cancer (cM1)
- Bilateral breast cancer
- Prior systemic therapy for the current breast cancer
- Pre-existing grade 2 or higher neuropathy
- Uncontrolled illness limiting study compliance
- Other malignancy within 5 years except certain skin or cervical cancers or approved by study PI
- Participation in other investigational breast cancer treatment trials
- Known HIV positivity affecting chemotherapy safety
- Allergic reactions to anastrozole, taxanes, anthracyclines, or cyclophosphamide
- Uncontrolled infection requiring recent parenteral antimicrobial therapy
- Any uncontrolled medical condition posing risk or interfering with participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
N
Nusayba A Bagegni, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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