A Phase II Study of Three-Day Partial Breast Radiation Therapy in Women with Breast Cancer

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Full Title

Ultra-Short External Beam-Based Accelerated Partial Breast Irradiation (APBI): A Phase II Toxicity Study Nested with a Non-inferiority Assessment of APBI in New Patient Cohorts

Purpose

The purpose of this study is to assess the safety and effectiveness of partial breast radiation therapy given over a three-day period (three weekdays in a row) in women with ductal carcinoma in situ (DCIS) or early-stage invasive breast cancer after lumpectomy. Women who are not in a research study usually receive radiation therapy to the whole breast over three weeks or receive partial breast irradiation over a five- to ten-day period.

The total dose of radiation in this study is calculated to be the same as that used in standard treatment; however, the dose patients receive during each radiation therapy session will be higher because the treatment will be delivered over three days rather than five to ten days. The goal is to see if this “ultra-short” treatment is well-tolerated and effective for preventing the cancer from returning.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be women with DCIS or early-stage invasive breast cancer that is less than 3 cm at its largest diameter and can be removed with lumpectomy. Clips need to be placed in the lumpectomy cavity to highlight the area to be treated with radiation therapy.
  • Patients must have negative surgical margins after lumpectomy.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for women age 45 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Atif Khan at 848-225-6334.

Protocol

19-300

Phase

II

Disease Status

Newly Diagnosed

Investigator

Diseases