Study on Single Fraction Breast Brachytherapy for Breast Cancer

Sponsor: Virginia Commonwealth University

Sponsor score: 0

ClinicalTrials ID:NCT07654257

This clinical trial is testing a new method of delivering radiation therapy directly to breast tumors in a single session over one day. The study aims to determine if this approach is safe for patients with certain types of breast cancer.

Patient Parameters

Program Overview

This study is exploring a new way to deliver radiation therapy directly to breast tumors using a technique called accelerated partial breast irradiation (APBI). The treatment involves placing a small device near the tumor to deliver radiation in just one session over a single day. The goal is to see if this method is safe for patients with specific types of breast cancer, such as Ductal Carcinoma in Situ (DCIS) or small invasive breast cancers.

Eligibility Criteria

Inclusion Criteria

  • Female patients diagnosed with Ductal Carcinoma in Situ (DCIS) or invasive breast cancer.
  • Aged between 40 and 85 at the time of diagnosis.
  • Have had a lumpectomy with no remaining cancer cells at the edges of the removed tissue.
  • Tumor size must be Tis, T1, or T2, with T2 tumors being 3 cm or smaller.
  • If the tumor is HER2-positive, the patient should be planning to receive or have already received HER2-targeted therapy.
  • For invasive breast cancer, a procedure to check lymph nodes under the arm must be done, unless certain criteria are met.
  • Patients aged 70 or older with specific tumor characteristics may not need lymph node checks.
  • Patients aged 50-69 with certain tumor characteristics may avoid lymph node checks at the surgeon's discretion.
  • Must be able to start brachytherapy within 12 weeks after surgery or chemotherapy.
  • Must understand and agree to sign a consent form.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Have active connective tissue diseases.
  • Have Paget's disease of the breast.
  • Have had breast cancer or DCIS before the current diagnosis.
  • Have had previous radiation therapy to the breast or chest.
  • Have multiple tumors in different areas of the breast.
  • Have cancer in both breasts at the same time.
  • Have surgical margins that cannot be assessed or are positive for cancer.
  • Have received chemotherapy before surgery.
  • Have a surgical cavity that cannot be clearly defined or is not suitable for the implant.
  • Have medical, psychological, or social conditions that may increase risk or affect adherence to the study.

Locations

FACILITYZIPCITYSTATE
Virginia Commonwealth University23298RichmondVirginia

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