Study on Accelerated Super-Hypofractionated Breast Brachytherapy for Breast Cancer

Sponsor: Virginia Commonwealth University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06185205

Provider View

This clinical trial is exploring the effects of delivering radiation treatment for breast cancer in just three sessions over two days. The study aims to understand both the benefits and potential side effects of this accelerated treatment approach.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety of a new method of delivering radiation therapy for breast cancer. This method, called accelerated partial breast irradiation (APBI), uses a special technique to target the cancer area with radiation over a short period of 1.5 days. The study will help determine if this approach is safe and effective for patients who have undergone a lumpectomy for breast cancer.

Description

This study is designed to test a new way of giving radiation therapy to breast cancer patients. Instead of the traditional longer course of treatment, this study uses a method called accelerated partial breast irradiation (APBI), which delivers radiation in a much shorter time frame. The treatment involves using a multicatheter interstitial implant to focus the radiation on the area where the cancer was removed, over just 1.5 days. The goal is to see if this faster treatment is safe and can effectively treat breast cancer after a lumpectomy.

Eligibility Criteria

Inclusion Criteria

  • Female patients.
  • Newly diagnosed with ductal carcinoma in situ (DCIS) or invasive breast cancer.
  • Aged between 45 and 79 at the time of diagnosis.
  • Have had a lumpectomy with no remaining cancer cells at the edges of the removed tissue.
  • Tumor size classified as Tis, T1, or T2, with T2 tumors being 3 cm or smaller.
  • If the tumor is HER2-positive, the patient must receive HER2-targeted therapy.
  • For invasive breast cancer, a procedure to check lymph nodes must be done, and nodes must be cancer-free.
  • Patients 70 or older with specific tumor characteristics may not need lymph node checks.
  • Must be able to understand and sign a consent form in English.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Have active collagen-vascular disease.
  • Have Paget's disease of the breast.
  • Have a history of DCIS or invasive breast cancer before the current diagnosis.
  • Have had previous radiation therapy to the breast or chest area.
  • Have multicentric carcinoma or cancer in both breasts at the same time.
  • Have surgical margins that cannot be assessed or are positive for cancer.
  • Have an excision cavity that cannot be clearly identified.
  • Do not meet specific treatment criteria as outlined in the study.
  • Have any medical, psychological, or social conditions that may increase risk or affect adherence to the study.

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