Alternative treatment for T4 breast cancer involving preoperative radiotherapy and immediate reconstruction
Feasibility of Preoperative Radiotherapy in T3 and T4 Breast Cancer Patients Who Are Responders to Neoadjuvant Chemotherapy to Allow for Immediate Reconstruction: a Prospective Study
This study is testing a new treatment for T4 breast cancer that combines radiation before surgery with immediate reconstruction to see if it can improve patient outcomes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT05412225 on ClinicalTrials.gov |
What this trial studies
This study tests a new treatment approach for T4 breast cancer that includes preoperative radiotherapy followed by mastectomy and immediate autologous reconstruction surgery. The goal is to evaluate the feasibility and safety of this alternative method compared to standard treatment practices. Participants will undergo neoadjuvant radiotherapy before their surgery, and the reconstruction will use tissue from another part of their body immediately after the mastectomy. The study aims to determine if this approach can improve outcomes for patients with invasive breast cancer.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 and older with biopsy-proven invasive breast cancer and specific tumor characteristics.
Not a fit: Patients with prior breast cancer, stage IV disease, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and immediate reconstruction option for patients with T4 breast cancer.
How similar studies have performed: Other studies have explored similar approaches, but this specific combination of preoperative radiotherapy and immediate reconstruction is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Audree Tadros, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Audree Tadros, MD
- Email: tadrosa@mskcc.org
- Phone: 646-888-4456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.