🔎 Trials Near Me

Home › Breast Cancer › NCT07053085

A Study of Surgery and Radiotherapy in People With Breast Cancer

RecruitingPhase 2

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)]

Who can join

Ages 18 and older · All sexes

Full eligibility 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.

About the study

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.

What is being tested

Sponsor: Memorial Sloan Kettering Cancer Center · Participants: 178 · Started: Sep 17, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07053085

Locations in the U.S.

New JerseyMemorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale
New YorkMemorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities ), Commack
Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison
Memorial Sloan Kettering Cancer Center (All protocol activites), New York
Memorial Sloan Kettering Nassau (Limited protocol activities), Rockville Centre

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.