Radiation vs. Radiation + Lymph Node Dissection for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if adding lymph node dissection to radiation therapy is more effective than radiation alone for treating breast cancer previously treated with chemotherapy and surgery. Radiation uses high-energy rays to kill cancer cells, while lymph node dissection removes lymph nodes where cancer may have spread. The trial targets individuals with specific types of breast cancer who underwent chemotherapy and surgery but might still have cancer in their lymph nodes. Participants must have breast cancer diagnosed as stage T1-3 N1 M0 and show no bulky lymph nodes after chemotherapy. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
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 is best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Past studies have linked the removal of axillary lymph nodes to a higher risk of lymphedema, which is swelling caused by lymph fluid, compared to less invasive methods like sentinel node biopsy. Despite this, the procedure is often used and generally considered safe for patients with certain types of breast cancer.
In contrast, radiation therapy on the lymph nodes has proven safe and effective in preventing cancer recurrence there. One study found that only 1.5% of patients experienced cancer returning in the lymph nodes over five years after receiving this treatment.
Overall, both treatments have been well-researched and are considered safe options in breast cancer care. They are usually well-tolerated, but like any treatment, they may have some risks and side effects. Discussing the benefits and risks with a healthcare provider is important to determine the best approach for each situation.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this trial because it compares two different approaches to managing lymph nodes in breast cancer treatment. The first approach combines axillary lymph node dissection (ALND) with nodal radiation therapy, which is unique because it involves surgical removal of lymph nodes alongside targeted radiation to remaining areas. The second approach uses only radiation but targets a broader area, including the full axilla and surrounding lymph nodes, without surgery. This trial could reveal whether one method offers better outcomes or fewer side effects, potentially changing how clinicians approach breast cancer treatment and improving patient quality of life.
What evidence suggests that this trial's treatments could be effective for breast cancer?
This trial will compare two treatment approaches for breast cancer: one involving Axillary Lymph Node Dissection (ALND) combined with nodal radiation therapy, and the other using axillary and nodal radiation therapy alone. Studies have shown that some breast cancer patients can skip ALND without affecting their survival, which can also lower the risk of lymphedema, a swelling caused by lymph fluid. Research indicates that radiation therapy greatly reduces the chances of breast cancer recurrence and lowers the risk of death from the disease. Specifically, targeting radiation at nearby lymph nodes has led to fewer cases of cancer returning and fewer deaths. Both treatments offer benefits, but radiation therapy has demonstrated strong results in preventing cancer recurrence.23678
Who Is on the Research Team?
Judy Boughey, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for breast cancer patients who've finished chemotherapy and surgery, with certain hormone receptor statuses checked. They should have a performance status of 0-1, indicating they're fully active or restricted in physically strenuous activity but ambulatory. Participants must not be pregnant, have no history of invasive cancer in the opposite breast within 5 years (except certain skin cancers or cervical carcinoma in situ), and no prior radiation therapy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Chemotherapy
Participants receive chemotherapy prior to surgery to shrink tumors
Surgery
Participants undergo axillary lymph node dissection or prepare for radiation therapy
Radiation Therapy
Participants receive radiation therapy 5 days a week for 5-6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Axillary Lymph Node Dissection (ALND)
- Axillary Radiation Therapy
- Nodal Radiation Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alliance for Clinical Trials in Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Canadian Cancer Trials Group
Collaborator