Study on Single-Dose Radiation Therapy Before Surgery for Early Stage Breast Cancer

Sponsor: Duke University

Sponsor score: 0

ClinicalTrials ID:NCT02482376

Provider View

This clinical trial is exploring whether a single, high-dose radiation treatment given before surgery can effectively treat early stage breast cancer while maintaining good cosmetic results. The study will monitor the appearance of the breast over time after treatment.

Patient Parameters

Program Overview

The aim of this study is to see if giving a single, high-dose radiation treatment (21Gy) before surgery can effectively treat early stage breast cancer while keeping the breast looking good. Researchers will check the appearance of the breast at different times after treatment to see how well it works. This approach may help target the cancer more accurately and reduce side effects by limiting radiation exposure to healthy breast tissue.

Description

This study is testing a new way to treat early stage breast cancer by giving a single, high-dose radiation treatment before surgery. The goal is to see if this method can effectively treat the cancer while keeping the breast looking good.

The benefits of this approach include:

  • Less healthy breast tissue is exposed to high radiation, which may reduce side effects.
  • More precise targeting of cancerous areas around the tumor.
  • Smaller treatment areas allow for higher doses, potentially speeding up treatment and making it more accessible.
  • This method is already used for other types of cancer and can be done at most radiation centers.

Researchers will also study how breast cancer responds to radiation by examining tumor samples before and after treatment.

Eligibility Criteria

Inclusion Criteria

  • Women diagnosed with ductal carcinoma in situ or invasive breast cancer.
  • Candidates for breast-conserving surgery (no previous breast or lymph node radiation, no signs of cancer in multiple areas, not pregnant, and no health issues preventing surgery).
  • Tumor size of 2 cm or smaller, classified as T1N0M0 or DCIS.
  • Age 60 or older, or 50-59 with a low Oncotype score (0-17). Oncotype testing is not needed for DCIS.
  • Estrogen receptor positive (ER+) and HER2 negative (HER2-) for invasive cancer. HER2 status is not needed for DCIS.
  • Women who can become pregnant must agree to use effective birth control during the study.
  • Blood tests showing adequate white blood cells, hemoglobin, and platelets within 30 days of joining the study.
  • Eligible for MRI with a good kidney function test (GFR ≥ 60 ml/min). A recent MRI is acceptable.
  • Breast imaging reviewed at Duke to confirm eligibility.

Exclusion Criteria

  • Previous chemotherapy before surgery.
  • Breast implant in the breast to be treated.
  • Medical conditions that may affect cosmetic results (e.g., Lupus, rheumatoid arthritis, scleroderma).
  • Unable to lie flat on the stomach for treatment planning.
  • HER2 positive cancer.
  • Positive pregnancy test.
  • Inadequate breast imaging to determine cancer stage.
  • No biopsy clip placed during diagnosis and unwilling to have one placed.
  • Unable to meet treatment planning requirements.

Locations

FACILITYZIPCITYSTATE
Duke Cancer Center27710DurhamNorth Carolina

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