Radiation vs. Radiation + Lymph Node Dissection for Breast Cancer

Recruiting at 1265 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

2012 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Radiation vs. Radiation + Lymph Node Dissection for Breast Cancer?

Research suggests that axillary lymph node dissection (ALND) may not be necessary for some breast cancer patients, as radiation therapy alone can effectively reduce the risk of cancer recurrence. Studies show that radiation on lymph node areas can decrease recurrence risk, and in some cases, omitting ALND can lead to better overall survival and physical functioning. ^{1 2 3 4 5}

Is radiation plus lymph node dissection safe for breast cancer treatment?

Radiation and lymph node dissection for breast cancer can lead to side effects like lymphedema (swelling due to fluid build-up) and reduced shoulder movement. Some studies suggest that avoiding or replacing lymph node dissection with radiation can reduce arm problems. ^{1 2 4 6 7}

How does the treatment of radiation plus lymph node dissection differ from other breast cancer treatments?

This treatment is unique because it combines radiation therapy with axillary lymph node dissection (ALND), which may be unnecessary for some patients with limited lymph node involvement. Studies suggest that omitting ALND and using radiation alone can reduce arm problems and maintain similar survival rates, making it a less invasive option for certain breast cancer patients. ^{1 4 5 8 9}

What is the purpose of this trial?

This randomized phase III trial studies lymph node dissection and radiation therapy to see how well it works compared to radiation therapy alone in treating patients with breast cancer previously treated with chemotherapy and surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x rays or protons to kill tumor cells. It is not yet known if radiation therapy works better alone or with lymph node dissection in treating patients with breast cancer previously treated with chemotherapy and surgery.

Research Team

Judy Boughey, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Impact of modern-day axillary treatment on patient reported arm morbidity and physical functioning in breast cancer patients. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of axillary surgery on outcome of clinically node positive breast cancer treated with neoadjuvant chemotherapy. [2023]

3. India pubmed.ncbi.nlm.nih.gov

Axillary management in patients with breast cancer and positive axilla at diagnosis. Experience in a Spanish university hospital with a 5-year follow-up. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Radiation field design in the ACOSOG Z0011 (Alliance) Trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Axillary lymph node dissection vs sentinel biopsy only among women with early-stage breast cancer and sentinel node metastasis: A systematic review and meta-analysis. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Loco-regional morbidity after breast conservation and axillary lymph node dissection for early breast cancer with or without regional nodes radiotherapy, perspectives in modern breast cancer treatment: the Skagen Trial 1 is active. [2022]

7. United States 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. [2018]

8. Netherlands pubmed.ncbi.nlm.nih.gov

A 10-year follow-up of treatment outcomes in patients with early stage breast cancer and clinically negative axillary nodes treated with tangential breast irradiation following sentinel lymph node dissection or axillary clearance. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Population-based analysis of occult primary breast cancer with axillary lymph node metastasis. [2022]