Dysautonomia International

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

Purpose

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

Breast Cancer
Invasive Breast Cancer

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: Female
Accepts Healthy Volunteers: No

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

Phase: Phase 1
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental 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.	Diagnostic Test: 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 Radiation: Neoadjuvant radiotherapy After biopsy, participants will undergo neoadjuvant radiotherapy/NART Other names: NART Procedure: 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 names: MRM

Recruiting Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey 07920