Study on Reducing Radiation in Breast Cancer Treatment for Hormone Sensitive, HER-2 Negative, Low Recurrence Score Breast Cancer (DEBRA)

Sponsor: NRG Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04852887

Provider View

This Phase III trial is exploring if breast cancer surgery combined with hormone therapy is as effective as adding radiation therapy for patients with certain types of breast cancer.

Patient Parameters

Program Overview

This study is investigating whether breast cancer surgery followed by hormone therapy can prevent cancer from returning as effectively as when radiation therapy is also used. The focus is on patients with hormone-sensitive, HER-2 negative breast cancer that has a low risk of recurrence.

Description

Breast conservation therapy, which includes surgery and radiation, has been a key treatment for early-stage breast cancer. However, radiation can be burdensome and not all patients may need it. This study aims to find out if some patients can safely skip radiation after surgery. In the past, studies showed that radiation after surgery helped prevent cancer from coming back, but with advancements in cancer detection and treatment, it's possible that some patients might not need radiation. This trial focuses on patients with small, hormone-sensitive, HER-2 negative breast cancers, which generally have a lower risk of coming back. The study will help determine if these patients can avoid radiation without increasing their risk of cancer returning.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent and, if in the U.S., allow the release of personal health information.
  • Must have a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must have had a lumpectomy with clear margins, meaning no cancer cells at the edge of the removed tissue.
  • Cancer must be in one breast and be a specific type called invasive adenocarcinoma.
  • Must have had lymph node evaluation.
  • Tumor must be small (2 cm or less) and not have spread to lymph nodes.
  • Must have a low Oncotype DX Recurrence Score (18 or less).
  • Tumor must be hormone receptor-positive and HER2-negative.
  • Can be premenopausal or postmenopausal.
  • Must start the study within 70 days after the last breast cancer surgery.
  • Must have recovered from surgery with no signs of infection.
  • Must have had a mammogram or MRI within 6 months before starting the study.
  • Must plan to take hormone therapy for at least 5 years.

Exclusion Criteria

  • Evidence of cancer spread beyond the breast.
  • Larger tumors or certain types of breast cancer.
  • Cancer that has spread to lymph nodes.
  • Previous mastectomy.
  • Suspicious lymph nodes unless proven cancer-free.
  • Certain types of breast cancer like sarcoma or lymphoma.
  • Cancer in more than one area of the breast.
  • History of breast cancer in the same breast.
  • Cancer in the other breast unless it's a specific type.
  • Positive surgical margins unless cleared by further surgery.
  • Plan to include radiation to lymph nodes.
  • Previous treatment for the current breast cancer.
  • History of other cancers within 5 years, except certain skin cancers.
  • Current use of certain hormone therapies.
  • Previous breast or chest radiation.
  • Certain autoimmune diseases.
  • Pregnancy or breastfeeding.
  • Any condition that makes study participation unsafe.
  • Use of investigational drugs within 30 days before starting the study.

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