RecruitingPhase 2NCT07053085

A Study of Surgery and Radiotherapy in People With Breast Cancer

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)]

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

162 participants

Start Date

Sep 17, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Breast Cancer HER2-positive Breast Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial studies whether giving radiation therapy after breast-conserving surgery (a lumpectomy) can be safely omitted or modified for certain patients with early-stage breast cancer. Researchers want to find out whether some patients can avoid or reduce radiation without increasing the risk of cancer returning. **You may be eligible if...** - You have early-stage breast cancer - You are scheduled for or have recently had breast-conserving surgery (lumpectomy) - Your cancer meets specific characteristics that suggest you may be a good candidate for reduced or no radiation - You are in good enough health to participate in the study **You may NOT be eligible if...** - Your cancer has spread to lymph nodes or distant organs - You need a mastectomy (full breast removal) - You have previously had radiation to the chest or breast area - Your overall health is too poor for surgery or follow-up Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELumpectomy 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)

RADIATIONRadiotherapy

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

DRUGTrastuzumab, 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.