Study on Surgery and Radiation Therapy for People with Breast Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT07053085
This clinical trial is exploring whether combining surgery and different types of radiation therapy with the usual treatment is more effective for treating a specific type of breast cancer that has spread to a few areas, known as oligometastatic HER2-positive breast cancer.
Patient Parameters
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Program Overview
The study aims to find out if adding surgery and two types of radiation therapy—locoregional radiation and SBRT (stereotactic body radiation therapy)—to the usual treatment can better manage oligometastatic HER2-positive breast cancer compared to the usual treatment alone. Researchers will also monitor any side effects from the treatment.
Description
Before joining the study, patients will receive the standard first-line treatment for their type of breast cancer, which includes medications like paclitaxel, trastuzumab, and pertuzumab. If the cancer does not progress for 3 to 12 months, patients can be enrolled in the study. Participants will be randomly assigned to one of two groups: one group will receive the usual treatment, and the other group will receive the usual treatment plus surgery and radiation therapy. All participants will be monitored until their cancer progresses or for up to three years, whichever comes first. The medications used in the study are approved by the FDA and are part of standard care.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of metastatic breast cancer.
- Have oligometastatic breast cancer, meaning the cancer has spread to 5 or fewer areas, and it has not spread to the brain or spinal cord.
- Have HER2-positive breast cancer, as determined by specific medical guidelines.
- All cancer sites must be treatable with either SBRT or surgery.
- Must have started first-line treatment 3 to 12 months ago and have no signs of cancer progression during this time.
- Be in good overall health, with a performance status score between 0 and 2.
Exclusion Criteria
- Any signs of cancer progression during the initial 3 to 12 months of first-line treatment.
- Need for a change in treatment due to cancer progression before joining the study.
- Health conditions that prevent receiving radiation, surgery, or standard treatment.
- Cancer that has spread to the brain or spinal cord.
- History of cancer that required chemotherapy in the past 10 years.
Inclusion of Underrepresented Populations:
- People of all races and ethnicities can join this trial. There is no bias based on age or race, and both men and women are welcome to participate.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities ) | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center (All protocol activites) | 10065 | New York | New York |
| Memorial Sloan Kettering Nassau (Limited protocol activities) | 11553 | Rockville Centre | New York |
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