A Study of an Alternative Treatment Approach (Preoperative Radiotherapy, Then Mastectomy, Then Immediate Reconstruction Surgery) in People With T4 Breast Cancer
NCT ID: NCT05412225
Last Updated: 2026-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
60 participants
INTERVENTIONAL
2022-06-06
2026-06-06
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Participants with clinical T4 biopsy-proven breast cancer
Participants with clinical T4 biopsy-proven breast cancer with no evidence of distant metastases who demonstrate a complete or partial response to standard neoadjuvant chemotherapy/NAC and desire immediate autologous reconstruction/IR will be eligible to enroll.
Pre-neoadjuvant radiotherapy (NART) biopsy
Participants will undergo pre-NART core biopsy guided by post-NAC MRI to the area of residual enhancement or to the previously biopsied cancer if no residual enhancement remains
Neoadjuvant radiotherapy
After biopsy, participants will undergo neoadjuvant radiotherapy/NART
Unilateral total mastectomy with axillary lymph node dissection
At 2-6 weeks after completion of NART, participants will undergo unilateral MRM (total mastectomy with axillary lymph node dissection), with resection of all involved breast skin. Skin-sparing mastectomy will not be permitted. All patients will also undergo simultaneous unilateral autologous-based breast reconstruction with DIEP, ms-TRAM, or latissimus dorsi flap.
Interventions
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Pre-neoadjuvant radiotherapy (NART) biopsy
Participants will undergo pre-NART core biopsy guided by post-NAC MRI to the area of residual enhancement or to the previously biopsied cancer if no residual enhancement remains
Neoadjuvant radiotherapy
After biopsy, participants will undergo neoadjuvant radiotherapy/NART
Unilateral total mastectomy with axillary lymph node dissection
At 2-6 weeks after completion of NART, participants will undergo unilateral MRM (total mastectomy with axillary lymph node dissection), with resection of all involved breast skin. Skin-sparing mastectomy will not be permitted. All patients will also undergo simultaneous unilateral autologous-based breast reconstruction with DIEP, ms-TRAM, or latissimus dorsi flap.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Audree Tadros, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Audree Tadros, MD
Role: primary
Audree Tadros, MD
Role: primary
Audree Tadros, MD
Role: primary
Audree Tadros, MD
Role: primary
Audree Tadros, MD
Role: primary
Audree Tadros, MD
Role: primary
Audree Tadros, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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22-136
Identifier Type: -
Identifier Source: org_study_id
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