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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05412225
• Other study ID #: 22-136
• Status: Recruiting
• Phase: Phase 1
• Start date: June 6, 2022
• Est. completion date: June 6, 2025

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Audree Tadros, MD
• Phone: 646-888-4456
• Email: tadrosa[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 6, 2025
• Est. primary completion date: June 6, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Invasive Breast Cancer

Intervention

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

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Limited Protocol Activities)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Limited Protocol Activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau (Limited Protocol Activities)	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the rate of wound complications for partners who receive neoadjuvant radiotherapy (NART) and modified radical mastectomy with immediate autologous reconstruction (IR) following neoadjuvant chemotherapy (NAC) compared w/current standard of care	Prospectively assess the feasibility of neoadjuvant radiotherapy (NART) and modified radical mastectomy with immediate autologous reconstruction (IR) following neoadjuvant chemotherapy (NAC) in patients with clinical T4 breast cancer, compared with the current standard of care ( [NAC, modified radical mastectomy [MRM] with delayed reconstruction, and postmastectomy radiotherapy [PMRT]), by assessing the rate of wound complications (surgical site infection [SSI], reoperative intervention, and flap failure)	5 years

External Links

•   Memorial Sloan Kettering Cancer Center