Status:
RECRUITING
A Study of an Alternative Treatment Approach (Preoperative Radiotherapy, Then Mastectomy, Then Immediate Reconstruction Surgery) in People With T4 Breast Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Breast Cancer
Invasive Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief 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 reconstr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 6 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05412225
Start Date
June 6 2022
End Date
June 6 2026
Last Update
July 2 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity)
Commack, New York, United States, 11725