A Study of Presurgical Radiotherapy, Then Mastectomy, Then Immediate Breast Reconstruction in Women with T4 Breast Cancer

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Full Title

Feasibility of preoperative radiotherapy in T3 and T4 breast cancer patients who are responders to neoadjuvant chemotherapy to allow for immediate reconstruction: a prospective study

Purpose

The purpose of this study is to assess the feasibility of a new approach to treat people with T4 breast cancer who have already received chemotherapy. T4 breast cancer occurs when the cancer has grown beyond normal breast tissue and into the chest wall or skin or has become swollen and causes pain. Doctors normally treat T4 breast cancer with chemotherapy followed by mastectomy and removal of underarm (axillary) lymph nodes. After mastectomy, patients normally receive radiation therapy and then have breast reconstruction surgery many months to years after completing radiotherapy.

Researchers are doing this study to evaluate an alternative treatment approach that involves giving radiation therapy before mastectomy and performing immediate reconstruction surgery using a patient’s own tissue at the time of mastectomy. They think this alternative treatment approach may be more effective for shrinking tumors than the standard treatment approach, and it may cause fewer side effects.

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have T4 breast cancer, received chemotherapy, and be interested in breast reconstruction using their own tissue.
  • Prior radiation therapy to the chest is not permitted.
  • This study is for women age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Audree Tadros at 646-888-4456.

Protocol

22-136

Phase

Phase I (phase 1)

Investigator

Diseases

ClinicalTrials.gov ID

NCT05412225