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Study of Preoperative Radiotherapy and Immediate Reconstruction for T4 Breast Cancer

This study is testing a different way to treat T4 breast cancer. It involves giving you radiation therapy (neoadjuvant radiotherapy, or NART) before your mastectomy (surgery to remove the breast). After the mastectomy, you would have immediate autologous reconstruction (IR) surgery. This means a surgeon uses tissue from another part of your body to rebuild your breast right away. This is different from standard reconstruction, which often happens later and can use implants or your own tissue. The study wants to see if this approach leads to fewer wound complications compared to current standard care. You might be able to join if you are a woman aged 18 or older with invasive breast cancer (cT3-4 cN0-3 tumor) that has responded to chemotherapy, and you want to have autologous reconstruction.

Study design
This is an interventional study planning to enroll 60 participants. It is testing a specific treatment approach.
What's involved
You would undergo a biopsy, then neoadjuvant radiotherapy, followed by a mastectomy with lymph node dissection and immediate reconstruction surgery 2-6 weeks later.
Compensation
Not stated in the trial record.
Follow-up
The study will compare wound complication rates at 5 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05412225

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~60 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:Pre-neoadjuvant radiotherapy (NART) biopsyNeoadjuvant radiotherapyUnilateral total mastectomy with axillary lymph node dissection

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over 5 years

Conditions

Breast Cancer
Invasive Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

7 sites across 2 states
New York4
New Jersey3

Study leadership

  • Minna Lee, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Minna Lee, MD
[email protected]
646-888-6898
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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 care5 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)