Surgery and focused radiation plus HER2-targeted therapy for oligometastatic HER2-positive breast cancer
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)]
Run by Memorial Sloan Kettering Cancer Center · NCT07053085 · Data updated 2026-11-12
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
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 178 (estimated) |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation, trastuzumab, pertuzumab |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Status | Recruiting |
| Started | September 17, 2025 |
| Main results expected | September 17, 2029 |
| Study ends | September 17, 2029 |
| Registry record updated | May 14, 2026 |
| Trial ID | NCT07053085 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States Recruiting -
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States Recruiting -
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States Recruiting -
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )
Commack, New York, United States Recruiting -
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States Recruiting -
Memorial Sloan Kettering Cancer Center (All protocol activites)
New York, New York, United States Recruiting
Show 1 more location
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Memorial Sloan Kettering Nassau (Limited protocol activities)
Rockville Centre, New York, United States Recruiting
Study contacts
- Principal investigator: Lior Braunstein, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Lior Braunstein, MD
- Email: braunstl@mskcc.org
- Phone: 201-775-7446
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.