A Study of Surgery and Radiotherapy in People With Breast Cancer

Recruiting now · Phase 2

Conditions studied: Metastatic Breast Cancer, HER2-positive Breast Cancer

In brief

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.

Key facts

Study ID

NCT07053085

Run by

Memorial Sloan Kettering Cancer Center

People needed

178

Starts

2025-09-17

Expected to finish

2029-09-17

Last updated by the study team

2026-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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