Memorial Sloan Kettering Cancer Center is enrolling participants in ARCHER, a randomized Phase II trial assessing whether consolidative locoregional surgery plus stereotactic body radiotherapy improves outcomes over standard systemic therapy alone in de novo oligometastatic HER2-positive breast cancer.
The ARCHER trial (NCT07053085) is an actively recruiting, interventional Phase II randomized study investigating the addition of consolidative local therapies—including lumpectomy or mastectomy, locoregional radiotherapy, and stereotactic body radiation therapy (SBRT)—to standard-of-care systemic regimens in patients presenting with de novo oligometastatic HER2-positive breast cancer. The trial is being conducted at Memorial Sloan Kettering Cancer Center.
The experimental arm combines ablative and resective locoregional interventions with curative intent alongside HER2-directed systemic therapy. Standard backbone regimens include trastuzumab, pertuzumab, and paclitaxel, either individually or in combination. The trial is designed to determine whether aggressive local consolidation of all known disease sites confers a meaningful efficacy advantage over systemic therapy alone in this molecularly defined metastatic subgroup.
The oligometastatic disease state—characterized by a limited number of distant metastatic lesions—has generated increasing interest as a potentially curable or durably controllable entity, particularly in HER2-amplified breast cancer where systemic disease control rates are high. ARCHER aims to prospectively test whether eradicating residual macroscopic disease through surgery and SBRT translates into improved progression-free or overall survival endpoints. Safety and tolerability of the combined modality approach are designated as co-primary or secondary objectives.
The trial is currently in the recruiting phase, and full eligibility criteria, primary endpoints, and planned enrollment numbers beyond the reported range of 25–145 participants have not been detailed in the available registration data. Clinicians managing HER2-positive metastatic breast cancer with oligometastatic presentations may wish to evaluate patient eligibility for referral.
Key points
- ARCHER is a randomized Phase II trial at Memorial Sloan Kettering evaluating consolidative surgery plus SBRT versus standard systemic therapy in de novo oligometastatic HER2+ breast cancer.
- Locoregional interventions include lumpectomy or mastectomy combined with radiotherapy and stereotactic body radiation therapy, all delivered with curative intent.
- Systemic therapy backbone consists of trastuzumab, pertuzumab, and/or paclitaxel per standard HER2-directed regimens.
- The trial is actively recruiting, with a planned enrollment range of 25–145 participants.
- Treatment-related adverse effects of the combined modality approach are being prospectively assessed alongside efficacy endpoints.
Why it matters
Oligometastatic HER2+ breast cancer represents a clinically distinct subset where aggressive local consolidation may offer durable disease control or potential cure; ARCHER is among the first prospective randomized trials to rigorously test this hypothesis in this molecularly defined population.