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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Prior ipsilateral breast cancer

Bilateral breast cancer

Pregnant

Stage IV disease at presentation

Trial design

Treatments tested in this trial

  • Pre-neoadjuvant radiotherapy (NART) biopsy
  • Neoadjuvant radiotherapy
  • Unilateral total mastectomy with axillary lymph node dissection

Treatment groups

60 Participants
are divided into 1 treatment group