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NCT Number: NCT05412225

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

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Invasive Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pre-neoadjuvant radiotherapy (NART) biopsy

Diagnostic Test

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

Neoadjuvant radiotherapy

Radiation

After biopsy, participants will undergo neoadjuvant radiotherapy/NART

Other names: NART

Unilateral total mastectomy with axillary lymph node dissection

Procedure

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.

Other names: MRM

Primary outcomes

  1. Compare the rate of wound complications for partners who receive neoadjuvant radiotherapy (NART) and modified radical mastectomy with immediate autologous reconstruction (IR) following neoadjuvant chemotherapy (NAC) compared w/current standard of care

    Time frame: 5 years

    Prospectively assess the feasibility of neoadjuvant radiotherapy (NART) and modified radical mastectomy with immediate autologous reconstruction (IR) following neoadjuvant chemotherapy (NAC) in patients with clinical T4 breast cancer, compared with the current standard of care ( [NAC, modified radical mastectomy [MRM] with delayed reconstruction, and postmastectomy radiotherapy [PMRT]), by assessing the rate of wound complications (surgical site infection [SSI], reoperative intervention, and flap failure)

Study contacts

Contact information is provided by the study sponsor or research team.

Atif Khan, MD

CONTACT

[email protected]

848-225-6334

Minna Lee, MD

CONTACT

[email protected]

646-888-6898

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2022
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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