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A Study of Surgery and Radiotherapy in People With Breast Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
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.
Official title: A Randomized Phase II Study of Consolidative Surgery and Radiotherapy With Curative Intent for De Novo Oligometastatic HER2+ Breast Cancer [Ablation and Resection for the Consolidation of Oligometastatic HER2+ Breast Cancer (ARCHER)]
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
162
Start Date
2025-09-17
Completion Date
2029-09-17
Last Updated
2026-02-27
Healthy Volunteers
No
Interventions
Lumpectomy or mastectomy
Resection of the primary breast tumor (ie. lumpectomy when possible or mastectomy when breast conservation not possible). Surgical resection of the primary breast tumor is to be performed per standard guidelines as applied to localized disease. Breast conserving surgery (ie. lumpectomy) is allowable per patient preference when supported by standard surgical practice. Mastectomy is preferred when breast conservation is declined by the patient, or if breast conservation would otherwise not be feasible in the early-stage setting (e.g. large tumor:breast volume ratio, inability to achieve negative margins with breast conservation, etc)
Radiotherapy
Radiotherapy will be delivered using external beam radiation per the guidelines.Radiotherapy will be delivered using external beam radiation per the guidelines set forth below, targeting two main compartments: 1. Patients will undergo radiotherapy to the breast/chest wall, and regional nodal basins (including the axilla, supraclavicular fossa and internal mammary chain) per the standard adjuvant approach for locally advanced disease, and 2. Patient will undergo stereotactic body radiotherapy (SBRT) or similarly-ablative approaches to sites of distant disease, including all observable foci and those that may have since resolved radiographically during systemic therapy
Trastuzumab, Pertuzumab, Paclitaxel, or a combination of these drugs
Continue to receive the standard treatment you have already started, which includes trastuzumab, pertuzumab, paclitaxel, or a combination of these drugs. This treatment is not part of the study and will be decided by your regular treating physician.
Locations (7)
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )
Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All protocol activites)
New York, New York, United States
Memorial Sloan Kettering Nassau (Limited protocol activities)
Rockville Centre, New York, United States