Radiation vs. Radiation + Lymph Node Dissection for Breast Cancer

Recruiting at 1265 trial locations

Overseen By Steven E. Sckolnik

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Alliance for Clinical Trials in Oncology

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

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.

Treatment Details

Interventions

• Axillary Lymph Node Dissection (ALND) (N/A)
• Axillary Radiation Therapy (N/A)
• Nodal Radiation Therapy (N/A)

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+