Preoperative Radiotherapy + Mastectomy for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for people with advanced breast cancer. It uses radiation to shrink the tumor before surgery and then rebuilds the breast using tissue from another part of the body. The goal is to see if this approach is safe and practical compared to standard treatments.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is preoperative radiotherapy for breast cancer generally safe for humans?
Preoperative radiotherapy for breast cancer has been shown to be generally safe, with mild side effects that do not require stopping the treatment. However, some patients may experience wound problems, such as infections or fistulas (abnormal connections between organs), which may need antibiotics or additional surgery.12345
How does the treatment of preoperative radiotherapy and mastectomy for breast cancer differ from other treatments?
What data supports the effectiveness of the treatment Preoperative Radiotherapy + Mastectomy for Breast Cancer?
Research suggests that preoperative radiotherapy, when combined with surgery, can help improve control and survival rates in breast cancer patients. Advances in radiotherapy techniques have made it more precise and effective, potentially increasing disease-free and overall survival rates when used before surgery.711121314
Who Is on the Research Team?
Audree Tadros, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
This trial is for women over 18 with invasive breast cancer at a specific stage (cT3-4 cN0-3). They should have responded to initial chemotherapy, want reconstruction surgery using their own tissue, and be able to read English. It's not for those with unresectable disease, bilateral or previous same-side breast cancer, pregnancy, no change or worsening after chemo, prior chest radiotherapy, or BMI over 40.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Chemotherapy
Participants receive standard neoadjuvant chemotherapy to assess response before proceeding to radiotherapy
Preoperative Radiotherapy
Participants receive radiotherapy before their mastectomy
Surgery and Immediate Reconstruction
Participants undergo mastectomy followed by immediate autologous reconstruction
Follow-up
Participants are monitored for safety and effectiveness after treatment, focusing on wound complications and surgical outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Neoadjuvant radiotherapy
- Pre-neoadjuvant radiotherapy (NART) biopsy
- Unilateral total mastectomy with axillary lymph node dissection
Neoadjuvant radiotherapy is already approved in United States, European Union, China for the following indications:
- Locally advanced breast cancer (LABC)
- T4 breast cancer
- Locally advanced breast cancer (LABC)
- T4 breast cancer
- Locally advanced breast cancer (LABC)
- T4 breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor