Adding surgery and radiotherapy to drug therapy for oligometastatic HER2-positive breast cancer

• Lumpectomy or mastectomy

  Intervention · PROCEDURE

  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

  Intervention · RADIATION

  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

  Intervention · DRUG

  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.

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)]

Sponsor

Memorial Sloan Kettering Cancer Center

Conditions

Metastatic Breast Cancer · HER2-positive Breast Cancer

Enrolling

178 people

Starts

2025-09-17

Est. completion

2029-09-17

Design

Open-label, randomized, parallel groups, Phase 2

Record

View on ClinicalTrials.gov ↗

The sponsor hasn't published answers to common questions for this trial.