RecruitingPhase 1NCT05412225

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

60 participants

Start Date

Jun 6, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Invasive Breast Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

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 Criteria8

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

Interventions

DIAGNOSTIC_TESTPre-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

RADIATIONNeoadjuvant radiotherapy

After biopsy, participants will undergo neoadjuvant radiotherapy/NART

PROCEDUREUnilateral 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.