NCT05412225 A Study of an Alternative Treatment Approach (Preoperative Radiotherapy, Then Mastectomy, Then Immediate Reconstruction Surgery) in People With T4 Breast Cancer
| NCT ID | NCT05412225 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-06-06 |
| Primary Completion | 2026-06-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2022-06-06 with a primary completion date of 2026-06-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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 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
Contact & Investigator
Audree Tadros, MD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT05412225 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05412225 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05412225 currently recruiting?
Yes, NCT05412225 is actively recruiting participants. Contact the research team at tadrosa@mskcc.org for enrollment information.
Where is the NCT05412225 trial being conducted?
This trial is being conducted at Basking Ridge, United States, Middletown, United States, Montvale, United States, Commack, United States and 3 additional locations.
Who is sponsoring the NCT05412225 clinical trial?
NCT05412225 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Audree Tadros, MD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 60 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.