A Study of an Alternative Treatment Approach (Preoperative Radiotherapy, Then Mastectomy, Then Immediate Reconstruction Surgery) in People With T4 Breast Cancer

Phase 1

Recruiting

• Conditions: Breast Cancer; Invasive Breast Cancer
• Interventions: Diagnostic Test: Pre-neoadjuvant radiotherapy (NART) biopsy; Radiation: Neoadjuvant radiotherapy; Procedure: Unilateral total mastectomy with axillary lymph node dissection

• Registration Number: NCT05412225
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-06
• Study First Submitted: 2022-06-06
• Study First Submitted QC: 2022-06-06
• Study First Posted: 2022-06-09
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-13
• Primary Completion: 2025-06-06
• Study Completion: 2025-06-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants with clinical T4 biopsy-proven breast cancer	Unilateral total mastectomy with axillary lymph node dissection	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.
Participants with clinical T4 biopsy-proven breast cancer	Neoadjuvant radiotherapy	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.
Participants with clinical T4 biopsy-proven breast cancer	Pre-neoadjuvant radiotherapy (NART) biopsy	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.

Primary Outcome Measures

Name	Time	Method
Compare the rate of wound complications for partners who receive neoadjuvant radiotherapy (NART) and modified radical mastectomy with immediate autologous reconstruction (IR) following neoadjuvant chemotherapy (NAC) compared w/current standard of care	5 years	Prospectively assess the feasibility of neoadjuvant radiotherapy (NART) and modified radical mastectomy with immediate autologous reconstruction (IR) following neoadjuvant chemotherapy (NAC) in patients with clinical T4 breast cancer, compared with the current standard of care ( \[NAC, modified radical mastectomy \[MRM\] with delayed reconstruction, and postmastectomy radiotherapy \[PMRT\]), by assessing the rate of wound complications (surgical site infection \[SSI\], reoperative intervention, and flap failure)

Trial Locations

Locations (7)

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities); 🇺🇸 Uniondale, 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 Monmouth (Limited Protocol Activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities); 🇺🇸 Montvale, New Jersey, United States