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

RecruitingPhase 1Ages 18 Years - anyFemaleMemorial Sloan Kettering Cancer Center
NCT05412225 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Pre-neoadjuvant radiotherapy (NART) biopsy
  • Neoadjuvant radiotherapy
  • Unilateral total mastectomy with axillary lymph node dissection
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Where

7 sites
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, United States
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity)
Commack, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, United States
Memorial Sloan Kettering Cancer Center
New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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