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

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Jun 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment method for women with advanced breast cancer. Instead of the usual approach, which typically involves surgery first and then reconstruction later, this study will give participants radiation therapy before their mastectomy (surgery to remove the breast). After the mastectomy, the doctors will perform immediate reconstruction using tissue from another part of the patient’s body. The goal is to see if this method is safe and effective compared to the standard treatment.

To join the study, participants must be women aged 18 or older with a specific type of invasive breast cancer. They should have had a good response to initial treatments and be suitable candidates for the reconstruction. Participants can expect close monitoring throughout the trial to ensure their safety and to gather important information about how well this new approach works. It's important to note that certain conditions, like previous breast cancer or being pregnant, may prevent someone from participating in this study.

Gender

FEMALE

Eligibility criteria

• 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