Study Comparing Two Radiation Schedules Before Breast Cancer Surgery with Reconstruction
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT05774678
This clinical trial is comparing two different radiation therapy schedules given before breast cancer surgery and reconstruction to see which is more effective and has better outcomes for patients.
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Program Overview
The study aims to compare the effects of two different radiation therapy schedules given before breast cancer surgery and reconstruction. One schedule uses the standard amount and number of radiation doses, while the other uses less radiation and fewer doses. Researchers want to see which schedule leads to better satisfaction with breast reconstruction, fewer complications, and improved cancer control.
Description
The main goals of this study are to compare how satisfied patients are with their breast reconstruction 18 months after surgery, how well the cancer is controlled, and the surgical outcomes between the two radiation schedules. Researchers will also look at the side effects of radiation, the cost of care, and the quality of life reported by patients. Additionally, the study will explore how the radiation affects the cancer and normal breast tissue at a molecular level, and how these changes relate to treatment outcomes. The study will also compare these results to a similar group of patients who received standard radiation after surgery. Some patients with a specific type of breast cancer will be included in a pilot study to see how they respond to the treatment. Blood samples will be analyzed to find markers that indicate how the body reacts to the treatment, and imaging data will be used to understand the impact on heart health.
Eligibility Criteria
Inclusion Criteria
- Age 18 years or older
- Diagnosed with invasive breast cancer, confirmed by tests
- Cancer stage T3-T4c or N1-N3; for a specific group, stage T4d, any N, M1
- Planning to have a mastectomy but not yet performed
- Planning to have breast reconstruction using tissue from the body
- For certain breast cancer types, must have residual disease after chemotherapy or have discussed treatment risks with a doctor
- For a specific group, must show partial response to treatment in tests
- Able to provide written consent
Exclusion Criteria
- Currently treating recurrent breast cancer in the same breast or lymph nodes
- Previous radiation treatment to the breast or nearby areas
- Have active scleroderma
- Pregnant women
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