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OncoMatch/Clinical Trials/NCT05412225

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

Is NCT05412225 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies non-drug interventions for breast cancer.

Phase 1RecruitingMemorial Sloan Kettering Cancer CenterNCT05412225Data as of May 2026

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.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Disease stage

Required: Stage CN0, CN1, CN2, CN3

Excluded: Stage IV

cT3-4 cN0-3 tumor; Stage IV disease at presentation [excluded]

Prior therapy

Must have received: neoadjuvant chemotherapy — neoadjuvant

Partial or complete response to NAC on imaging and clinical examination using the Response Evaluation Criteria in Solid Tumors (RECISTv1.1) definition.

Cannot have received:

Prior ipsilateral breast cancer

Cannot have received:

Bilateral breast cancer

Cannot have received: thoracic radiotherapy

Prior history of thoracic radiotherapy

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) · Basking Ridge, New Jersey
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities) · Middletown, New Jersey
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, New Jersey
  • Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity) · Commack, New York
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities) · Harrison, New York

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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