Adding Surgery and Radiation to the Usual Treatment for HER2-Positive Breast Cancer That Had Already Spread at Diagnosis
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This phase III trial evaluates the effect of adding locoregional therapy (surgery and radiation) and metastasis-directed stereotactic body radiation therapy (SBRT) to standard systemic therapy following standard HER2-targeted systemic therapy, compared to standard systemic therapy alone, in treating patients with HER2-positive stage IV breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or to a limited number of sites (oligometastatic). The usual approach for patients with (oligo)metastatic HER2-positive breast cancer is systemic drug treatment, which means medicines that travel through the whole body to treat both the breast and any areas where the cancer has spread. There are a number of approved HER2-targeted systemic therapy regimens available to patients. These typically include immunotherapy and/or chemotherapy. Immunotherapy drugs may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Unlike systemic therapy, locoregional therapies like surgery and radiation are focused treatments at the site of disease, delivered with the intent of sparing healthy tissues. Breast surgeries such as breast conserving therapy or total mastectomy are procedures in which the cancerous breast tissue (and healthy breast tissue in the case of total mastectomy) are surgically removed from the body. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Adding locoregional therapy, as well as metastasis-directed SBRT, to standard systemic therapy may help patients with (oligo)metastatic, HER2-positive stage IV breast cancer live longer overall or before their cancer progresses, and may help more patients achieve no evidence of disease, when compared to standard systemic therapy alone.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony histologicznie rak piersi HER2-dodatni, który rozprzestrzenił się już w momencie rozpoznania (stadium IV) bez wcześniejszej historii raka piersi
- •Od 1 do 5 przerzutów w innych częściach ciała (rozprzestrzenianie się na niezbyt wiele miejsc)
- •Potwierdzona pozytywność HER2 w guzie piersi i w przerzutach zgodnie z wytycznymi medycznymi
- •Jeśli są przerzuty do mózgu, maksymalnie 5 guzów, każdy poniżej 2 cm średnicy
- •Brak potwierdzenia choroby opon mózgowych
- •Pacjent jeszcze nie rozpoczął leczenia lub już zaczął leczenie i ukończył 1-3 cykli terapii
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- October 13, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (59)
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, United States
Smilow Cancer Hospital-Derby Care Center
Derby, United States
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, United States
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, United States
Smilow Cancer Hospital Care Center - Guilford
Guilford, United States
Smilow Cancer Hospital-Hamden Care Center
Hamden, United States
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, United States
Yale University
New Haven, United States
Yale-New Haven Hospital North Haven Medical Center
North Haven, United States
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, United States
Smilow Cancer Hospital-Torrington Care Center
Torrington, United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, United States
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, United States
Smilow Cancer Hospital Care Center - Waterford
Waterford, United States
Orlando Health Cancer Institute
Orlando, United States
OSF Saint Joseph Medical Center
Bloomington, United States
Illinois CancerCare-Bloomington
Bloomington, United States
Illinois CancerCare-Canton
Canton, United States
Illinois CancerCare-Carthage
Carthage, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, United States
Decatur Memorial Hospital
Decatur, United States
Illinois CancerCare-Eureka
Eureka, United States
Illinois CancerCare-Galesburg
Galesburg, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, United States
Illinois CancerCare-Macomb
Macomb, United States
Cancer Care Center of O'Fallon
O'Fallon, United States
HSHS Saint Elizabeth's Hospital
O'Fallon, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, United States
Illinois CancerCare-Pekin
Pekin, United States
Illinois CancerCare-Peoria
Peoria, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, United States
OSF Saint Francis Medical Center
Peoria, United States
Illinois CancerCare-Peru
Peru, United States
Illinois CancerCare-Princeton
Princeton, United States
Southern Illinois University School of Medicine
Springfield, United States
Springfield Clinic
Springfield, United States
Springfield Memorial Hospital
Springfield, United States
Illinois CancerCare - Washington
Washington, United States
Mercy Cancer Center-West Lakes
Clive, United States
Iowa Methodist Medical Center
Des Moines, United States
Broadlawns Medical Center
Des Moines, United States
Mercy Medical Center - Des Moines
Des Moines, United States
Mercy Medical Center-West Lakes
West Des Moines, United States
Ascension Via Christi Hospitals Wichita
Wichita, United States
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, United States
Baptist Cancer Center-Grenada
Grenada, United States
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, United States
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, United States
Saint Francis Medical Center
Cape Girardeau, United States
Thomas Jefferson University Hospital
Philadelphia, United States
Asplundh Cancer Pavilion
Willow Grove, United States
Smilow Cancer Hospital Care Center - Westerly
Westerly, United States
Lexington Health
West Columbia, United States
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, United States
Bon Secours Memorial Regional Medical Center
Mechanicsville, United States
Bon Secours Saint Francis Medical Center
Midlothian, United States
Bon Secours Saint Mary's Hospital
Richmond, United States
Bon Secours Cancer Institute at Reynolds Crossing
Richmond, United States
Trial contact
Site Public Contact
Philip E. Lammers
PRINCIPAL_INVESTIGATOR
Site Public Contact
Mariya Rozenblit
PRINCIPAL_INVESTIGATOR
Site Public Contact
Shane R. Stecklein
PRINCIPAL_INVESTIGATOR
Site Public Contact
Bryan A. Faller
PRINCIPAL_INVESTIGATOR
Site Public Contact
Site Public Contact
Site Public Contact
Site Public Contact
Site Public Contact
Richard L. Deming
PRINCIPAL_INVESTIGATOR
Site Public Contact
Seema Harichand-Herdt
PRINCIPAL_INVESTIGATOR
Site Public Contact
Site Public Contact
Dennis F. Moore
PRINCIPAL_INVESTIGATOR
Site Public Contact
Site Public Contact
Site Public Contact
Elena Shagisultanova
PRINCIPAL_INVESTIGATOR
Site Public Contact
Steven A. Madden
PRINCIPAL_INVESTIGATOR
Site Public Contact
William J. Irvin
PRINCIPAL_INVESTIGATOR
Site Public Contact
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/14/2026.
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