Testing Radiation and HER2-targeted Therapy Versus HER2-targeted Therapy Alone for Low-risk HER2-positive Breast Cancer

Sponsor: NRG Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05705401

Provider View

This study is exploring whether adding radiation therapy to HER2-targeted treatment after breast-conserving surgery can improve outcomes for patients with low-risk HER2-positive breast cancer, compared to using HER2-targeted treatment alone.

Patient Parameters

Program Overview

This Phase III trial is comparing two treatment approaches for patients with early-stage, low-risk HER2-positive breast cancer who have had breast-conserving surgery. One group will receive HER2-targeted therapy without additional radiation, while the other group will receive both HER2-targeted therapy and radiation. The study aims to see if adding radiation helps prevent cancer from returning.

Description

In the past, breast-conserving surgery followed by radiation was the standard treatment for breast cancer. However, with the development of HER2-targeted therapies, outcomes for patients with HER2-positive breast cancer have improved significantly. This study is investigating whether patients with low-risk HER2-positive breast cancer can safely skip radiation therapy after surgery without increasing the risk of cancer returning.

The study will focus on patients who have small tumors and no cancer in the lymph nodes. These patients will receive HER2-targeted therapy, which may include drugs like trastuzumab and paclitaxel. The goal is to determine if radiation therapy is necessary for these patients or if they can avoid it, reducing the side effects and costs associated with radiation.

The study will also look at the long-term outcomes, such as the rate of cancer returning and overall survival, to see if skipping radiation affects these factors. By identifying patients who can safely avoid radiation, the study aims to improve the quality of life for those with low-risk HER2-positive breast cancer.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent to participate in the study.
  • Male and female patients who have had breast-conserving surgery and completed at least 12 weeks of chemotherapy with HER2-targeted therapy.
  • Must be 40 years or older.
  • Must have a good performance status, meaning they are able to carry out daily activities with little or no assistance.
  • Must have confirmed HER2-positive breast cancer.
  • Must have had axillary staging to check for cancer in the lymph nodes.
  • For patients receiving adjuvant therapy, the primary tumor must be 2 cm or smaller, and lymph nodes must be cancer-free.
  • For patients receiving neoadjuvant therapy, the primary tumor must be less than 3 cm before treatment, with no cancer in the lymph nodes.
  • Must have had a mammogram or MRI within the past year.
  • HIV-positive patients on effective treatment with undetectable viral load are eligible.

Exclusion Criteria

  • Evidence of cancer spread beyond the breast.
  • Tumors larger than 2 cm for adjuvant therapy patients or larger than 3 cm for neoadjuvant therapy patients.
  • Cancer found in the lymph nodes at any time.
  • Planning to have or have had a mastectomy.
  • Suspicious findings in the breast or lymph nodes that have not been confirmed as non-cancerous.
  • Non-breast cancers like sarcoma or lymphoma.
  • Multiple cancerous areas in the breast.
  • Paget's disease of the nipple.
  • Other invasive breast cancers or ductal carcinoma in situ (DCIS) at the same time.
  • Positive surgical margins that cannot be cleared.
  • Plans to include radiation to the lymph nodes.
  • Previous invasive breast cancer treatment.
  • Use of estrogen replacement therapy unless stopped before the study.
  • Previous radiation to the breast or chest.
  • Certain autoimmune diseases like lupus or scleroderma.
  • Pregnancy or breastfeeding, or planning to become pregnant during the study.
  • Use of investigational drugs within 30 days before the study.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.