Clinical Trial Summary (S2511)
Adding Surgery and Radiation to the Usual Treatment for HER2- Positive Breast Cancer That Had Already Spread at Diagnosis
What is the purpose of this clinical trial?
This trial asks if combining different treatment types can help people with HER2-positive breast cancer that spread to as many as 5 areas outside the breast before they were diagnosed.
This is called HER2-positive de novo oligometastatic breast cancer.
The study compares 2 options for treating cancer that shrinks with initial (first) drug treatment:
| standard drug treatment + surgery and radiation therapy |
standard drug treatment alone |
This trial is set up to find out:
- For people with cancer that shrinks with initial treatment: Can adding surgery and radiation to standard drug treatment help them live longer?
Why is this trial important?
This is the first large-scale study to test standard drug treatment plus surgery and radiation after initial treatment specifically for HER2-positive de novo oligometastatic breast cancer. Researchers hope the study will lead to better treatment options for people in the future.
Who can be in this trial?
This trial is for adults age 18 or older who have HER2-positive breast cancer.
This trial may be for people who:
- Have cancer that had already spread outside the breast at diagnosis to as many as 5 other areas
- Haven’t started treatment – or have finished up to 3 cycles of standard drug treatment
This trial is not for people who:
- Have leptomeningeal disease (cancer in the protective coverings of the brain and spinal cord)
- Have more than 5 brain lesions
What treatments will I get?
How long will I be in the trial?
You’ll be in the study for up to 10 years.
After you finish treatment, you’ll have visits with your study doctor so they can see how you’re doing. You’ll have a visit every 6 months until 5 years after you started the study. Then you’ll have a visit once a year.
You’ll also have imaging scans (like MRI or CT scans) to see if the cancer has gotten worse. You’ll have these scans once every 3 or 4 months for about 5 years. After that, if the cancer has not gotten worse, you’ll have imaging scans once a year until your part in the study ends.
Are there costs? Will I get paid?
To learn what costs will and won’t be covered, talk to your health care provider and insurance provider.
You will not be paid for joining the study.
Where can I find more information about this trial?
- Talk with your health care provider
- Call the National Cancer Institute at 1-800-4-CANCER
- Go to www.ClinicalTrials.gov and search the national clinical trial number: NCT07578116
- For a list of trial locations, visit swog.org/NCI-S2511
Key Information
Information your doctor or trial navigator may need to help you.
Protocol Number
S2511
NCT Number
NCT07578116
Full Trial Title
Randomized Phase III Trial Of Multimodality Therapy Versus Standard of Care Systemic Therapy in HER2 Positive (HER2+) de novo (AJCC Stage IV) Oligometastatic Breast Cancer with Response to Initial Chemotherapy
Trial Sponsors
SWOG Cancer Research Network
Publication Date