Radiation vs. Radiation + Lymph Node Dissection for Breast Cancer

Not currently recruiting at 1294 trial locations

Overseen By Steven E. Sckolnik

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Alliance for Clinical Trials in Oncology

Must be taking: Anti-HER2 therapy

Disqualifiers: Inflammatory breast cancer, Other malignancy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

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. ^{1 2 3 4 5}

Why 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. ^{2 3 6 7 8}

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

I had a biopsy confirming cancer in my underarm lymph nodes before or shortly after starting chemotherapy.

My cancer's hormone and HER2 status were tested before starting chemotherapy.

I have finished all my chemotherapy before surgery, without breaks.

Exclusion Criteria

Patients must not be pregnant or nursing

I haven't had surgery to check lymph nodes in my armpit before or during my chemotherapy.

I have never had invasive breast cancer in my other breast.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Chemotherapy

Participants receive chemotherapy prior to surgery to shrink tumors

Varies

Surgery

Participants undergo axillary lymph node dissection or prepare for radiation therapy

1 day

Radiation Therapy

Participants receive radiation therapy 5 days a week for 5-6 weeks

5-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years every 6 months, then annually for 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Axillary Lymph Node Dissection (ALND)
• Axillary Radiation Therapy
• Nodal Radiation Therapy

Trial Overview

The study compares two approaches after chemotherapy and surgery: one group undergoes axillary lymph node dissection (ALND) where lymph nodes are surgically removed; another receives only axillary radiation therapy to destroy any remaining cancer cells. The goal is to determine which method is more effective for treating breast cancer that has spread to nearby lymph nodes.

How Is the Trial Designed?

Group I: Arm 2: Axillary radiation and nodal radiation therapy Experimental Treatment 2 Interventions

Radiation Therapy: Radiation is delivered to the breast/chest wall, full axilla including Levels I, II, III, supraclavicular nodes and internal mammary nodes in the first 3 intercostal spaces. Treatment will be given 5 days a week over 5-6 weeks.

Group II: Arm 1: ALND + nodal radiation therapy Experimental Treatment 2 Interventions

Surgery: For patients randomized to axillary lymph node dissection (ALND), it is recommended that a complete level I and II dissection with resection of minimum of a total of 8 lymph nodes (SLN and ALND together) be done. Level III dissection is not required, but may be performed at the discretion of the surgeon. If fewer than 8 lymph nodes (SLN and ALND together) are resected, then the patient will discontinue protocol treatment. Radiation Therapy: Radiation is delivered to the breast/chest wall, undissected axilla, supraclavicular nodes and internal mammary nodes in the first 3 intercostal spaces. Treatment will be given 5 days a week over 5-6 weeks.

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Canadian Cancer Trials Group

Collaborator

Trials

135

Recruited

70,300+

Published Research Related to This Trial

In a study of 292 breast cancer patients with clinically node-positive disease treated with neoadjuvant therapy, axillary lymph node dissection (ALND) did not significantly improve axillary recurrence rates or overall survival compared to targeted axillary surgery (TAS).

Five-year axillary recurrence-free survival was 100% for TAS and 90% for ALND, indicating that TAS may be a safer option without compromising outcomes, as ALND did not show a clear benefit in preventing recurrence or enhancing survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of axillary surgery on outcome of clinically node positive breast cancer treated with neoadjuvant chemotherapy. Dux, J., Habibi, M., Malik, H., et al.[2023]

The MSKCC Additional Nodal Metastasis Nomogram effectively identifies patients with invasive breast cancer who have a low risk of additional axillary metastases, potentially allowing them to avoid unnecessary Axillary Lymph Node Dissection (ALND).

In a study of 175 patients, the nomogram demonstrated high sensitivity (92.3%) and specificity (81.4%), indicating it is a reliable tool for predicting axillary lymph node status in patients with sentinel node macrometastasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of a predictive model of axillary lymph node status in patients with sentinel node metastasis from breast cancer. A retrospective cohort study. Vieni, S., Graceffa, G., La Mendola, R., et al.[2018]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11083357/

Axillary Surgery for Breast Cancer in 2024 - PMC

For patients with clinically node-negative BC and up to two positive lymph nodes found on sentinel lymph node biopsy, ALND can be safely avoided ...

2.

nature.com

nature.com/articles/s41598-025-91405-1

The impact of axillary lymph node dissection on ...

This study supports the omission of ALND in T1-2N1mi breast cancer patients undergoing mastectomy, demonstrating comparable survival outcomes to those ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0960977625004709

Comparing axillary dissection or not in breast cancer surgery

The Risk of lymphedema is reduced by 65 % with sentinel node biopsy compared to axillary lymph node dissection, benefiting patients. •. No significant outcome ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6223503/

Axillary Lymph Node Dissection for Breast Cancer

The aim of this study was to assess the efficacy and complications of ALND in patients with breast cancer treated with mastectomy and breast-conserving surgery.

5.

frontiersin.org

frontiersin.org/journals/oncology/articles/10.3389/fonc.2025.1563586/full

Evaluating the survival outcomes in clinical node stage 2 ...

This study aims to compare the oncologic outcomes of SNB alone versus SNB combined with axillary lymph node dissection (ALND) in this patient ...

6.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e12608

Outcomes from targeted axillary lymph node dissection ...

ALND was avoided in approximately half of patients who presented with axillary node metastases and became ycN0 post-NAC.

7.

jamanetwork.com

jamanetwork.com/journals/jamasurgery/fullarticle/2805951

Safety of Targeted Axillary Dissection After Neoadjuvant ...

This cohort study assesses 3-year clinical outcomes in patients with node-positive breast cancer who underwent targeted axillary dissection ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38368292/

Oncological Safety of Skipping Axillary Lymph Node ...

Our findings suggest that SLNB could afford comparable outcomes to ALND in patients with early breast cancer and one to two metastatic SLNs who underwent TM.