NCT07053085RecruitingPhase 2
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)]
Source: ClinicalTrials.gov · Last updated 14 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 178 (estimated)
- First submitted
- 30 Jun 2025
- Start date
- 17 Sept 2025
- Primary completion date
- 17 Sept 2029
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07053085
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 178
- From 17 Sept 2025 to the primary completion date, 17 Sept 2029
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Any foci of disease progression during initial 3-12 months of first-line systemic therapy (as determined by treating clinician)
- 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
Age
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) Coordinator of this site? Confirm its status | Basking Ridge | United States | Recruiting |
| Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) Coordinator of this site? Confirm its status | Commack | United States | Recruiting |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) Coordinator of this site? Confirm its status | Harrison | United States | Recruiting |
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) Coordinator of this site? Confirm its status | Middletown | United States | Recruiting |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) Coordinator of this site? Confirm its status | Montvale | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center (All Protocol Activites) Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Memorial Sloan Kettering Nassau (Limited Protocol Activities) Coordinator of this site? Confirm its status | Rockville Centre | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.