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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05412225
Other study ID # 22-136
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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