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NCT05412225 · ClinicalTrials.gov registry record · Phase 1
A Study of an Alternative Treatment Approach (Preoperative Radiotherapy, Then Mastectomy, Then Immediate Reconstruction Surgery) in People With T4 Breast Cancer
A Phase 1 study of Breast Cancer and Invasive Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 7
- Study locations
NCT05412225: Recruiting Phase 1 study of Breast Cancer and Invasive Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
NCT05412225 is a Phase 1 study of Breast Cancer and Invasive Breast Cancer that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 60 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05412225, a Phase 1 study of Breast Cancer and Invasive Breast Cancer, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 7
- Study locations
Study 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.
Primary Outcome
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,
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Pre-neoadjuvant radiotherapy (NART) biopsy
- RADIATION Neoadjuvant radiotherapy
- PROCEDURE Unilateral total mastectomy with axillary lymph node dissection
Study Locations (7)
New York
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity) - Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) - Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-06-06 |
| Est. Completion | 2026-06-06 |
| Phase | Phase 1 |
What NCT05412225 shows while recruiting
NCT05412225 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Pre-neoadjuvant radiotherapy (NART) biopsy is the first listed.
NCT05412225 lists 7 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT05412225 about?
NCT05412225 is a clinical study titled "A Study of an Alternative Treatment Approach (Preoperative Radiotherapy, Then Mastectomy, Then Immediate Reconstruction Surgery) in People With T4 Breast Cancer". 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 immediat...
What is the current status of trial NCT05412225?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2022-06-06. Estimated completion is 2026-06-06.
What conditions does trial NCT05412225 study?
This clinical trial studies the following conditions: Breast Cancer, Invasive Breast Cancer.
What interventions are being tested in trial NCT05412225?
The interventions under investigation include: Pre-neoadjuvant radiotherapy (NART) biopsy (DIAGNOSTIC_TEST), Neoadjuvant radiotherapy (RADIATION), Unilateral total mastectomy with axillary lymph node dissection (PROCEDURE).
Who is sponsoring clinical trial NCT05412225?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05412225 being conducted?
This trial has 7 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05412225's enrollment target sits among peer trials
60 736th of 1224 higher than 468 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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