Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Female sex, aged ≥18 years, with biopsy-proven invasive breast cancer
cT4 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 is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT05412225

Recruitment Status:

Recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There is 1 Location for this study

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Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Audree Tadros, MD
Contact
646-888-4456

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Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT05412225

Recruitment Status:

Recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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