NeoTAILOR: A Biomarker-Directed Approach to Guide Pre-Surgery Treatment for Stage II/III ER-Positive, HER2-Negative Breast Cancer

Sponsor: Washington University School of Medicine

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05837455

Provider View

This study is exploring a new way to choose pre-surgery treatments for postmenopausal women with stage II/III ER-positive, HER2-negative breast cancer. The focus is on improving treatment outcomes, especially for Black patients, and identifying those who may not need chemotherapy before surgery.

Patient Parameters

Program Overview

The NeoTAILOR study is testing a new method to guide treatment choices before surgery for women with stage II/III ER-positive, HER2-negative breast cancer. By using specific biomarkers, the study aims to improve how well patients respond to treatment and to find out if some patients can avoid chemotherapy before surgery. The study is particularly focused on outcomes for Black patients.

Description

In this study, patients are categorized into risk groups based on certain biomarkers:

  • Low Risk:

    • Ki67 level is 10% or lower, or
    • The cancer is classified as Luminal A subtype by a specific test (PAM50).

  • High Risk:

    • The cancer is not Luminal A subtype by PAM50, or
    • If the PAM50 test is not clear, patients will be placed in the high-risk group and have a tumor biopsy at Week 4.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed with stage II or III ER-positive, HER2-negative breast cancer.
  • Tumor size is 2 cm or larger, or has spread to nearby lymph nodes.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Eligible for pre-surgery treatment with aromatase inhibitors or standard chemotherapy.
  • Able to undergo an MRI with contrast.
  • Adequate bone marrow and organ function.
  • Treated and cured hepatitis C is allowed.
  • At least 18 years old and postmenopausal.
  • Able to understand and sign a consent form and follow the study schedule.

Exclusion Criteria

  • Inflammatory breast cancer or cancer that has spread.
  • Cancer in both breasts.
  • Previous treatment for the current breast cancer.
  • Severe nerve damage (Grade 2 or higher).
  • Uncontrolled illness that affects study participation.
  • Other cancers within 5 years, except certain skin or cervical cancers.
  • Participating in another breast cancer treatment trial.
  • Unable to have an MRI due to allergies or kidney issues.
  • HIV positive if it affects chemotherapy safety.
  • Allergies to certain cancer drugs.
  • Active infections needing treatment within 7 days before the study.
  • Any medical condition that poses a risk or affects study participation.

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