A Study of an Alternative Treatment Approach (Preoperative Radiotherapy, Then Mastectomy, Then Immediate Reconstruction Surgery) in People With T4 Breast Cancer
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
- Breast Cancer
- Invasive Breast Cancer
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrolment target
- 60
- Started
- 6 June 2022
- Main results due
- 6 June 2027
- Study sites
- 7
- Registry updated
- 24 September 2026
Can you take part?
- Aged 18 years and over.
- Women only.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(7)
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
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States
Recruiting
Showing 7 of 7 sites. 7 of the 7 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT05412225. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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