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A Study of Surgery and Radiotherapy for HER2-positive Metastatic Breast Cancer

This study is looking at whether adding surgery (lumpectomy or mastectomy) and radiation therapy to your usual treatment for HER2-positive metastatic breast cancer is more effective than your usual treatment alone. Your usual treatment includes drugs like trastuzumab, pertuzumab, and paclitaxel. Researchers will also study any side effects. You may be able to join if you are 18 or older, have HER2-positive metastatic breast cancer that has spread to five or fewer spots (oligometastatic), and have not had your cancer spread to your brain. The study will measure how long people live without their cancer getting worse (progression-free survival) over three years. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 178 participants. After initial standard treatment, participants will be randomly assigned to one of two groups.
What's involved
You will receive standard of care first-line systemic therapy for 3-12 months. After this, you will be randomly assigned to a study arm, which may include surgery and/or radiation therapy.
Compensation
Not stated in the trial record.
Follow-up
All participants will be followed until their disease progresses or for three years after randomization, whichever comes first.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07053085

A Study of Surgery and Radiotherapy in People With Breast Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~178 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:Lumpectomy or mastectomyRadiotherapyTrastuzumab, Pertuzumab, Paclitaxel, or a combination of these drugs

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (PFS)
Measured over 3 years

Conditions

Metastatic Breast Cancer
HER2-positive Breast Cancer

Explore related trials

Breast CarcinomaERBB2 Gene

Where it's being run

7 sites across 2 states
New York4
New Jersey3

Study leadership

  • Lior Braunstein, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Lior Braunstein, MD
[email protected]
201-775-7446
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).
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.

What this trial measures

  • Progression-free survival (PFS)3 years

    with PFS defined as the time of randomization to the date of clinical or radiographic disease progression or death (by any cause in the absence of progression).