Actively Recruiting
A Study of an Alternative Treatment Approach (Preoperative Radiotherapy, Then Mastectomy, Then Immediate Reconstruction Surgery) in People With T4 Breast Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-11
60
Participants Needed
7
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of an Alternative Treatment Approach (Preoperative Radiotherapy, Then Mastectomy, Then Immediate Reconstruction Surgery) in People With T4 Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female sex, aged 18 years or older, with biopsy-proven invasive breast cancer
- Tumor stage cT3 or cT4 with lymph node status cN0 to cN3
- Partial or complete response to neoadjuvant chemotherapy based on imaging and clinical examination using RECIST v1.1 criteria
- Desire to have autologous reconstruction and assessed as appropriate candidate by a plastic and reconstructive surgeon
- Able to read and understand English
You will not qualify if you...
- Prior cancer in the same breast (ipsilateral breast cancer)
- Cancer in both breasts (bilateral breast cancer)
- Pregnant at the time of study
- Stage IV breast cancer at diagnosis
- Stable or progressive disease after neoadjuvant chemotherapy
- Breast disease that cannot be surgically removed
- Body mass index (BMI) greater than 40
- Previous thoracic radiotherapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
A
Audree Tadros, MD
CONTACT
A
Atif Khan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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