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

Description

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

Study Overview

Study Details

Study overview

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.

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

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

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Basking Ridge

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

Middletown

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States, 07748

Montvale

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States, 07645

Commack

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity), Commack, New York, United States, 11725

Harrison

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York, United States, 10604

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Uniondale

Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, New York, United States, 11553

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Memorial Sloan Kettering Cancer Center,

Audree Tadros, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

2025-06-06