Active not recruitingPHASE3INTERVENTIONAL

Comparison of Axillary Lymph Node Dissection with Axillary Radiation for Patients with Node-Positive Breast Cancer Treated with Chemotherapy

This research is looking into the best way to treat breast cancer that has spread to the lymph nodes under the arm, specifically after someone has already had chemotherapy and surgery. Doctors want to see if removing these lymph nodes with surgery (called axillary lymph node dissection) followed by radiation therapy works better than just having radiation therapy alone. Radiation therapy uses high-energy rays to kill cancer cells. The main goal is to find out which approach is better at preventing the cancer from returning in the breast or surrounding areas. The study wants to make sure patients get the most effective treatment with the fewest side effects.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Alliance for Clinical Trials in Oncology

Enrolment target

2,012

Start

24 Feb 2014

Estimated completion

01 Jan 2026

Stage II Breast Cancer Stage IIIA Breast Cancer

What is this study about?

This important study is designed for people who have been diagnosed with breast cancer that has spread to the lymph nodes under the arm. These are called 'node-positive' breast cancers. Before joining this study, participants would have already completed a course of chemotherapy and had surgery.

The main question the researchers are trying to answer is whether it's better to: 1) have surgery to remove the affected lymph nodes (called axillary lymph node dissection) followed by radiation therapy; or 2) just have radiation therapy to the lymph nodes. Radiation therapy uses powerful energy, like X-rays, to destroy cancer cells that might remain. Both approaches aim to reduce the chance of the cancer coming back in the treated area.

By comparing these two treatments, doctors hope to understand which method is more effective at stopping the cancer from returning, and how each treatment affects patients' overall recovery and quality of life. The study will also look at how long people live after treatment and whether there are any differences between the two groups. Finding the best treatment can help improve how breast cancer is managed in the future.

Key takeaways

Compares two treatments for breast cancer that spread to lymph nodes.
Both groups receive radiation therapy, but one also has lymph node surgery.
Aims to find the best way to prevent cancer from coming back.
You would have already completed chemotherapy and surgery.
Participation involves 5-6 weeks of treatment, plus 5 years of follow-up.
Helps doctors improve future breast cancer care.

Who may be eligible?

This study is for adults aged 18 or older.

To be considered, you must have been diagnosed with a specific type of breast cancer (Stage II or IIIA) that had spread to your lymph nodes. You must have already completed chemotherapy and had surgery for the breast cancer. Importantly, your cancer must not be an inflammatory type, and you shouldn't have had other serious cancers in the last five years (minor skin cancers are okay).

Doctors would have checked your lymph nodes with a scan and biopsy at diagnosis, and they must know the specific characteristics (like ER, PR, HER2 status) of your cancer. You must have finished a certain amount of chemotherapy before surgery without your cancer getting worse.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Do you have Stage II or IIIA breast cancer that spread to lymph nodes?
Have you already finished your full course of chemotherapy and surgery?
Is your cancer NOT inflammatory breast cancer?
Have you had no other serious cancers recently (mild skin cancer is okay)?
Was your lymph node status and cancer type (ER, PR, HER2) known at diagnosis?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to one of two groups, like flipping a coin, so it's not your choice which treatment you get.

One group will have surgery to remove lymph nodes under the arm, then start radiation therapy 3-12 weeks later. This radiation will be given 5 days a week for 5-6 weeks. The other group will go straight to radiation therapy to the armpit and surrounding lymph node areas, also for 5 days a week for 5-6 weeks.

After your treatment finishes, doctors will follow up with you regularly. You'll have check-ups every six months for the first two years, and then once a year for another three years. The total follow-up period after treatment would be about five years.

Potential risks and benefits

The potential benefits of taking part include receiving one of two standard treatments for breast cancer, with careful monitoring by a medical team. You might also contribute to important medical knowledge that could help future patients. Potential risks are those usually associated with surgery (if in that group) and radiation therapy, such as pain, swelling, fatigue, skin changes, or nerve problems. You are free to withdraw from the study at any time for any reason, without affecting your standard care.

Locations (1246)

Southern Cancer Center PC-Daphne
Verified postcode
Daphne, United States
Mobile Infirmary Medical Center
Verified postcode
Mobile, United States
Southern Cancer Center PC-Mobile
Verified postcode
Mobile, United States
Southern Cancer Center PC-Providence
Verified postcode
Mobile, United States
Southern Cancer Center PC-Springhill
Verified postcode
Mobile, United States
University of South Alabama Mitchell Cancer Institute
Verified postcode
Mobile, United States
Anchorage Associates in Radiation Medicine
Verified postcode
Anchorage, United States
Anchorage Radiation Therapy Center
Verified postcode
Anchorage, United States
Alaska Breast Care and Surgery LLC
Verified postcode
Anchorage, United States
Alaska Oncology and Hematology LLC
Verified postcode
Anchorage, United States
Alaska Regional Hospital
Verified postcode
Anchorage, United States
Alaska Women's Cancer Care
Verified postcode
Anchorage, United States

Common questions

What is 'node-positive breast cancer'?

It means breast cancer that has spread to the nearby lymph nodes, usually under the arm.

What is chemotherapy and why do I need it before the study?

Chemotherapy uses drugs to kill cancer cells throughout your body. In this study, it's given before surgery to shrink the tumour and is a necessary part of your treatment before you can join.

What does 'randomized' mean in a study?

It means you are assigned to a treatment group by chance, similar to drawing straws or flipping a coin. This helps make the study fair.

What is radiation therapy?

Radiation therapy uses high-energy rays, like X-rays, to target and destroy cancer cells in a specific area of your body.

Will I know which treatment group I'm in?

Yes, you will know whether you are having lymph node surgery followed by radiation, or just radiation therapy.