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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 1

Conditions: Breast Cancer; Invasive Breast Cancer

Treatments: Radiation: Neoadjuvant radiotherapy; Procedure: Unilateral total mastectomy with axillary lymph node dissection; Diagnostic Test: Pre-neoadjuvant radiotherapy (NART) biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT05412225

22-136

Details and patient eligibility

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Participants with clinical T4 biopsy-proven breast cancer

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Pre-neoadjuvant radiotherapy (NART) biopsy

Procedure: Unilateral total mastectomy with axillary lymph node dissection

Radiation: Neoadjuvant radiotherapy