Study on Non-Surgical Treatment Approach for Managing Breast Cancer

Sponsor: Ohio State University Comprehensive Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07217990

Provider View

This clinical trial is exploring a non-surgical treatment option for patients with locally advanced breast cancer to see if it is as effective as the standard surgical approach.

Patient Parameters

Program Overview

The aim of this study is to find out if a non-surgical treatment can be as effective as surgery in managing breast cancer for patients who show an exceptional response to initial chemotherapy. The study will also look into personalized markers that can predict how well a patient might respond to chemotherapy and if there is any remaining cancer.

Description

This study is testing a new approach to treating breast cancer without surgery for patients who respond exceptionally well to initial chemotherapy. The main goal is to see if this non-surgical method leads to similar cancer recurrence rates as the traditional surgical approach.

The study will also explore personalized markers that can predict how well a patient might respond to chemotherapy and if there is any remaining cancer. Additionally, it will validate a deep learning model developed to predict complete response to chemotherapy in breast cancer patients.

This is a phase II trial with up to 84 participants. All patients will receive standard chemotherapy before surgery and will be assessed for a complete response using MRI, biopsy, and blood tests. Those who show a complete response will be placed in the non-surgical group, while others will proceed with surgery.

Eligibility Criteria

Inclusion Criteria

  • Must provide signed and dated consent to participate.
  • Willing to follow all study procedures and available for the study duration.
  • Male or female, aged 18 years or older.
  • Diagnosed with early-stage breast cancer and have HER2-positive or triple negative breast cancer.
  • Planning to receive chemotherapy and radiation therapy before surgery.

Exclusion Criteria

  • Pregnant or breastfeeding.
  • Currently incarcerated.
  • Receiving any investigational drugs or treatments during their breast cancer treatment.
  • Have skin involvement or cancer that has spread to other parts of the body.

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