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RECRUITING
NCT05412225
PHASE1

A Study of an Alternative Treatment Approach (Preoperative Radiotherapy, Then Mastectomy, Then Immediate Reconstruction Surgery) in People With T4 Breast Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

The purpose of this study to test an alternative treatment approach that involves giving participants radiotherapy before their mastectomy (preoperative radiotherapy) and performing immediate reconstruction surgery at the time of mastectomy. The immediate reconstruction surgery is called an immediate autologous reconstruction (IR) and is different than the standard reconstruction surgery people with T4 breast cancer have. IR is a surgical procedure where immediately following your mastectomy, the surgeon takes tissue from another part of your body and uses it to re-create your breast. The standard reconstruction surgery occurs later and can be done with an implant or tissue from your body. The main purpose of this study to find out if the alternative treatment approach shown above is feasible. The study will see how safe this alternative treatment approach is compared with the standard treatment approach.

Official 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2022-06-06

Completion Date

2026-06-06

Last Updated

2026-02-11

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Pre-neoadjuvant radiotherapy (NART) biopsy

Participants will undergo pre-NART core biopsy guided by post-NAC MRI to the area of residual enhancement or to the previously biopsied cancer if no residual enhancement remains

RADIATION

Neoadjuvant radiotherapy

After biopsy, participants will undergo neoadjuvant radiotherapy/NART

PROCEDURE

Unilateral total mastectomy with axillary lymph node dissection

At 2-6 weeks after completion of NART, participants will undergo unilateral MRM (total mastectomy with axillary lymph node dissection), with resection of all involved breast skin. Skin-sparing mastectomy will not be permitted. All patients will also undergo simultaneous unilateral autologous-based breast reconstruction with DIEP, ms-TRAM, or latissimus dorsi flap.

Locations (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States