Study on Biomarker Optimization of Pre-Surgery Therapy in Breast Cancer

Sponsor: University of Illinois at Chicago

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06441890

Provider View

This clinical trial is exploring how a specific test, called MammaPrint®/BluePrint®, can help tailor pre-surgery treatment for men and women with early-stage HER2-positive breast cancer. The test is performed on a biopsy sample to determine the best treatment approach.

Patient Parameters

Program Overview

The study focuses on men and women with early-stage HER2-positive breast cancer. A special test, MammaPrint®/BluePrint®, will be done on a biopsy sample to identify the cancer's subtype. If the cancer is HER2-enriched, patients may be recommended for pre-surgery chemotherapy and can join the study.

Description

This study involves adult men and women with early-stage HER2-positive breast cancer. A test called MammaPrint®/BluePrint® will be performed on a biopsy sample to determine the cancer's subtype. If the cancer is identified as HER2-enriched, and the oncologist recommends pre-surgery chemotherapy, patients can participate in the study. The goal is to optimize treatment before surgery based on the cancer's specific characteristics.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a good overall health status (ECOG score of 0, 1, or 2).
  • Have a confirmed diagnosis of invasive breast cancer from a biopsy within the last 90 days.
  • Cancer must be HER2-positive based on specific medical tests.
  • Cancer must be HER2-enriched according to the MammaPrint/BluePrint test within the last 90 days.
  • Surgery to remove the breast tumor is planned, with lymph node sampling.
  • Oncologist recommends pre-surgery chemotherapy.
  • No signs of cancer spread to distant parts of the body.
  • Cancer stage must be within specific limits (cT1c-T3, cN0-N2).
  • Heart function must be adequate, with a left ventricular ejection fraction of at least 50%.
  • Must have adequate blood cell counts and organ function based on specific lab tests.
  • Can have multiple breast tumors if the treatment is suitable for all.
  • Must be able to provide informed consent and agree to share health information.
  • Women of childbearing potential must use contraception and have a negative pregnancy test.
  • Must be able to understand and follow study procedures.
  • Patients with HIV/AIDS can participate if on stable treatment without interfering medications.
  • Patients with Hepatitis B or C can participate if on appropriate treatment and meet liver function criteria.

Exclusion Criteria

  • Have received any prior treatment for this breast cancer.
  • Have an active infection requiring treatment at the time of joining the study.
  • Are pregnant or breastfeeding.
  • Have another cancer that could affect the study's safety or effectiveness.
  • Have a mental or medical condition preventing informed consent or participation.
  • Have major health issues like severe liver, heart, or blood sugar problems.
  • Have allergies to any chemotherapy drugs used in the study.
  • Have significant nerve damage.
  • Are prisoners.

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