Preoperative Radiotherapy and Reconstruction for T4 Breast Cancer
A Study of an Alternative Treatment Approach (Preoperative Radiotherapy, Then Mastectomy, Then Immediate Reconstruction Surgery) in People With T4 Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Memorial Sloan Kettering Cancer Center · Other
Who this trial is looking for
This trial is looking for women aged 18 and older with a specific type of breast cancer. Participants will receive radiotherapy before having mastectomy and immediate reconstruction surgery.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old
I have been diagnosed with invasive breast cancer
I have a T3-4 tumor
I want to have autologous reconstruction surgery
I can read and understand English
You may not be able to join if
I have had breast cancer in the past
I have cancer in both breasts
I am currently pregnant
I have stage IV breast cancer
I have stable or progressively worsening disease after chemotherapy
My breast disease cannot be surgically removed
My BMI is over 40
I have had thoracic radiotherapy before
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 wi…
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.
Trial Locations
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Status
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 re…
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
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