Alternative treatment for T4 breast cancer involving preoperative radiotherapy and immediate reconstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study tests a new treatment approach for T4 breast cancer that includes preoperative radiotherapy followed by mastectomy and immediate autologous reconstruction surgery. The goal is to evaluate the feasibility and safety of this alternative method compared to standard treatment practices. Participants will undergo neoadjuvant radiotherapy before their surgery, and the reconstruction will use tissue from another part of their body immediately after the mastectomy. The study aims to determine if this approach can improve outcomes for patients with invasive breast cancer.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Minna Lee, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Minna Lee, MD
• Email: leem15@mskcc.org
• Phone: 646-888-6898

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.