RecruitingPhase 2NCT05837455

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

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

Sponsor

Washington University School of Medicine

Enrollment

81 participants

Start Date

May 30, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Cancer of the Breast

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (NeoTAILOR) is testing a personalized approach to pre-surgery treatment for postmenopausal women with hormone receptor-positive, HER2-negative breast cancer (stages II–III). Using tumor biomarkers from a breast MRI, the study aims to guide which combination of hormone therapy and/or chemotherapy is most likely to shrink the cancer before surgery. **You may be eligible if...** - You are postmenopausal (age 60 or older, or younger with absent periods and confirmed hormonal status) - You have been newly diagnosed with hormone receptor-positive, HER2-negative breast cancer at stage II or III - Your tumor is at least 2 cm, or you have involved lymph nodes - You are able to receive both aromatase inhibitor therapy and chemotherapy - You can tolerate an MRI with contrast dye **You may NOT be eligible if...** - You have inflammatory breast cancer - Your cancer has already spread to other organs (metastatic) - You have had prior treatment for this diagnosis - You have active hepatitis C (unless treated and cured) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVENTANA MIB-1 Ki67 assay

Ki67 scoring determination (standard of care) utilizing the Ki67 MIB-1 assay (clone 30-9) (VENTANA) will be performed at baseline, Week 4 (+/- 14 days - high-risk group only), and at time of surgery in accordance with the International Ki67 in Breast Cancer Working Group guidelines.

DEVICEOncotype DX® Recurrence Score

Oncotype DX® Recurrence Score (RS) testing - assessing expression of 21 genes including 16 cancer-related genes and 5 reference genes - will be performed as standard of care in a central laboratory (Exact Sciences) on RNA extracted from formalin-fixed paraffin-embedded core-biopsy samples.

DEVICEPAM50-based Prosigna breast cancer gene signature assay

This PAM50-based Prosigna breast cancer gene signature assay for intrinsic molecular subtype determination will be performed on formalin-fixed, paraffin-embedded (FFPE) core-biopsy samples.

DRUGAnastrozole

Standard of care. All patients must start on anastrozole at time of enrollment but may switch to another aromatase inhibitor (letrozole or exemestane) due to toxicity or financial/other concerns at discretion of investigator after a discussion with the PI. Every effort to minimize interruption of aromatase inhibitor (AI) therapy is recommended.

DRUGCombination anthracycline and/or taxane based treatment

Standard of care

Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT05837455

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