A Study of an Alternative Treatment Approach (Preoperative Radiotherapy, Then Mastectomy, Then Immediate Reconstruction Surgery) in People With T4 Breast Cancer (NCT05412225)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey
Age range: 18 Years
🧪 Interventions in This Study
- Pre-neoadjuvant radiotherapy (NART) biopsy (DIAGNOSTIC_TEST)
- Neoadjuvant radiotherapy (RADIATION)
- Unilateral total mastectomy with axillary lymph node dissection (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (7 Sites)
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity) — Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York
- Memorial Sloan Kettering Cancer Center — New York, New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York
📞 Contact the Study Coordinator
Phone: (646) 888-6898
Email: leem15@mskcc.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.