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Surgery and focused radiation plus HER2-targeted therapy for oligometastatic HER2-positive 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)]

Phase 2 Interventional Memorial Sloan Kettering Cancer Center · NCT07053085

This will test whether adding surgery and precise radiation to standard HER2-targeted treatment helps people with oligometastatic HER2-positive breast cancer whose disease is controlled after initial therapy.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment162 (estimated)
Ages18 Years and up
SexAll
SponsorMemorial Sloan Kettering Cancer Center Academic / other
Drugs / interventionschemotherapy, radiation, trastuzumab, pertuzumab
Locations7 sites (Basking Ridge, New Jersey and 6 other locations)
Trial IDNCT07053085 on ClinicalTrials.gov

What this trial studies

This is a randomized Phase 2 trial that enrolls adults with HER2-positive oligometastatic breast cancer (no CNS disease, ≤5 metastatic lesions) who have had 3–12 months of first-line systemic therapy without progression. After registration, participants are randomly assigned 1:1 to continue standard systemic HER2-directed therapy alone or to receive consolidative local therapy (surgery and/or locoregional radiotherapy including SBRT) to all known sites in addition to systemic therapy. All HER2-directed agents are given per standard of care and local treatments are chosen based on lesion size and location to allow safe resection or SBRT. Patients are followed until disease progression or for up to 3 years after randomization to monitor outcomes and side effects.

Who should consider this trial

Good fit: Adults (≥18) with pathologically confirmed HER2-positive metastatic breast cancer limited to ≤5 extracranial lesions, no CNS involvement, ECOG 0–2, and with disease controlled for 3–12 months on first-line systemic therapy are ideal candidates.

Not a fit: Patients with more than five metastatic lesions, any CNS metastases, disease progression during the initial 3–12 month therapy window, poor performance status, or lesions not safely treatable by resection or SBRT are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, adding targeted surgery and radiotherapy could improve local control and delay progression, potentially prolonging the time patients remain stable on systemic HER2 therapy.

How similar studies have performed: Randomized data are limited in HER2-positive breast cancer specifically, though prior trials in oligometastatic disease across cancer types have shown that local consolidative therapy can prolong progression-free survival in some settings.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Age ≥ 18 years.
* Pathologically-confirmed metastatic breast cancer.
* Oligometastatic breast cancer (≤5 discrete metastatic lesions) without CNS involvement; as seen on standard imaging during initial workup and monitoring prior to registration.
* HER2-positive breast cancer per CAP/ASCO guidelines as determined by staff pathologist (any estrogen or progesterone receptor status).
* Based on size and location, all metastatic sites can be safely treated with either SBRT or resection.
* Enrolled at least 3 months (and up to 12 months) after initiation of first-line systemic therapy AND without evidence of progression as determined by treating clinician (whether clinically or radiographically) during this window. (ie. in the judgement of the treating clinician, based on standard evaluations, all known disease must be controlled prior to enrollment).
* ECOG performance status 0-2; KPS 60-100

Exclusion Criteria:

* Any foci of disease progression during initial 3-12 months of first-line systemic therapy (as determined by treating clinician)
* Escalation of systemic therapy line due to progressive disease (i.e. initiated second-line therapy prior to enrollment).
* Comorbidities precluding receipt of radiotherapy, surgery or standard systemic therapy.
* Intracranial or intrathecal/intramedullary spinal disease (ie. CNS involvement is excluded from the study; epidural/vertebral disease is permitted)
* Prior cancer history requiring chemotherapy within the past 10 years (ie. prior cancers are permitted provided no chemotherapy was administered).

Inclusion of Underrepresented Populations

* Individuals of all races and ethnic groups are eligible for this trial. There is no bias towards age or race in the clinical trial outlined. This trial is open to the accrual of men and women.

Where this trial is running

Basking Ridge, New Jersey and 6 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Breast CancerHER2-positive Breast CancerConsolidative surgeryRadiotherapyAblationResection25-145
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.