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

Last updated: July 1, 2025
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Recruiting

Phase

1

Condition

Breast Cancer

Cancer

Treatment

Pre-neoadjuvant radiotherapy (NART) biopsy

Unilateral total mastectomy with axillary lymph node dissection

Neoadjuvant radiotherapy

Clinical Study ID

NCT05412225
22-136
  • Ages > 18
  • Female

Study 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

Inclusion

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 theResponse Evaluation Criteria in Solid Tumors (RECISTv1.1) definition.

  • Desire to undergo autologous reconstruction and assessed to be an appropriatecandidate by a plastic and reconstructive surgeon

  • Able to read and understand English

Exclusion

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

Study Design

Total Participants: 60
Treatment Group(s): 3
Primary Treatment: Pre-neoadjuvant radiotherapy (NART) biopsy
Phase: 1
Study Start date:
June 06, 2022
Estimated Completion Date:
June 06, 2026

Connect with a study center

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey 07920
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey 07645
    United States

    Active - Recruiting

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

    Commack, New York 11725
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York 10604
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York 11553
    United States

    Active - Recruiting

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