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NCT05412225PHASE1Recruiting

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

Memorial Sloan Kettering Cancer Center

Start Date

6/6/2022

Completion Date

6/6/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Female sex, aged ≥18 years, with biopsy-proven invasive breast cancer * cT3-4 cN0-3 tumor * Partial or complete response to NAC on imaging and clinical examination using the Response Evaluation Criteria in Solid Tumors (RECISTv1.1) definition. * Desire to undergo autologous reconstruction and assessed to be an appropriate candidate by a plastic and reconstructive surgeon * Able to read and understand English Exclusion Criteria: * Prior ipsilateral breast cancer * Bilateral breast cancer * Pregnant * Stage IV disease at presentation * Stable disease or progressive disease after NAC * Surgically unresectable breast disease * BMI \>40 * Prior history of thoracic radiotherapy

Interventions

DIAGNOSTIC_TEST

Pre-neoadjuvant radiotherapy (NART) biopsy

RADIATION

Neoadjuvant radiotherapy

PROCEDURE

Unilateral total mastectomy with axillary lymph node dissection

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Conditions

Breast CancerInvasive Breast Cancer

Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey 07920

United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey 07748

United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey 07645

United States

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

Commack, New York 11725

United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York 10604

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York 11553

United States