A Study of Surgery and Radiotherapy in People With Breast Cancer
Start Date
9/17/2025
Completion Date
9/17/2029
Summary
The researchers are doing this study to see if the combination of surgery, locoregional radiation therapy, SBRT (stereotactic body radiation therapy), and the usual approach is more effective in treating oligometastatic HER2-positive breast cancer than the usual approach alone. The researchers will also study the side effects of the study treatment.
Detailed Description
Prior to randomization, patients will receive standard of care first-line systemic therapy as defined by NCCN guidelines (paclitaxel, trastuzumab and pertuzumab at the time of study activation). Following a 3-12 month period without evidence of progression as determined by the treating clinician, patients may be registered and then randomly assigned in 1:1 fashion to one of two study arms. All patients will be followed until progression of disease or 3 years after randomization, whichever comes first. All HER2-directed agents are FDA-approved and administered per standard of care practice.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Lumpectomy or mastectomy
Radiotherapy
Trastuzumab, Pertuzumab, Paclitaxel, or a combination of these drugs
Conditions
Locations
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey 07920
United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey 07748
United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey 07645
United States
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )
Commack, New York 11725
United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York 10604
United States
Memorial Sloan Kettering Cancer Center (All protocol activites)
New York, New York 10065
United States
Memorial Sloan Kettering Nassau (Limited protocol activities)
Rockville Centre, New York 11553
United States