Study Comparing Two Types of Radiation Therapy for Breast Cancer with Lymph Node Involvement

Sponsor: Washington University School of Medicine

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06559540

Provider View

This clinical trial is comparing two different radiation therapy schedules to see which is more effective and tolerable for patients with breast cancer that has spread to the lymph nodes. The study will look at side effects, cancer control, and quality of life.

Patient Parameters

Program Overview

This study is exploring two different radiation therapy schedules for patients with breast cancer that has spread to the lymph nodes. The standard treatment involves radiation over three weeks, while the new approach uses a higher dose over one week. Researchers want to see if the shorter treatment is as effective and safe, especially when it involves more exposure to areas like the arm, shoulder, heart, and lungs. Participants will be randomly assigned to one of the two treatment schedules, and the study will track side effects, cancer recurrence, and overall survival, as well as patient-reported quality of life. Blood samples will also be collected to study potential side effects on the heart and tissue.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with invasive breast cancer, including metaplastic breast cancer.
  • Cancer stage: cT1-3 primary tumor, cN1-2 or pN1-2.
  • Biopsy-confirmed cancer in axillary lymph nodes.
  • Underwent partial or full mastectomy with no cancer at the edges of the removed tissue.
  • Had lymph node surgery, either sentinel lymph node biopsy or axillary lymph node dissection.
  • Received or will receive standard chemotherapy and/or hormone therapy.
  • Radiation therapy planned at BJH or a Siteman satellite location.
  • Female, aged 18 or older.
  • Good overall health (ECOG performance status 0 or 1).
  • English speaker.
  • Able to understand and willing to sign a consent form.

Exclusion Criteria

  • Cancer has spread to distant parts of the body.
  • Diagnosed with non-breast cancers like sarcoma or lymphoma.
  • Diagnosed with cancer in both breasts.
  • Advanced cancer stage (cT4 or pT4) or skin involvement.
  • Suspicious lymph nodes in certain areas like above the collarbone.
  • Previous radiation that overlaps with current treatment plan.
  • Previous breast cancer or current diagnosis more than a year ago.
  • Certain autoimmune diseases like lupus or scleroderma.
  • Other medical conditions limiting life expectancy to less than 2 years.
  • Other cancers that could interfere with the study.
  • More than 8 weeks since last breast cancer treatment before starting radiation.
  • Planning to have chemotherapy at the same time.
  • Pregnant women are excluded.

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