A Study of Surgery and Radiotherapy in People With Breast Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT07053085
This study evaluates the efficacy of combining surgery, locoregional radiation, and SBRT with standard care in treating oligometastatic HER2-positive breast cancer. Eligible participants are adults with ≤5 metastatic lesions, no CNS involvement, and stable disease post-first-line therapy. Interventions include lumpectomy/mastectomy, radiotherapy, and continuation of standard drug treatment.
Patient Parameters
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Program Overview
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.
Description
Prior to randomization, patients will receive standard of care first-line systemic therapy as defined by NCCN guidelines (paclitaxel, trastuzumab and pertuzumab at the time of study activation). Following a 3-12 month period without evidence of progression as determined by the treating clinician, patients may be registered and then randomly assigned in 1:1 fashion to one of two study arms. All patients will be followed until progression of disease or 3 years after randomization, whichever comes first. All HER2-directed agents are FDA-approved and administered per standard of care practice.
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities ) | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center (All protocol activites) | 10065 | New York | New York |
| Memorial Sloan Kettering Nassau (Limited protocol activities) | 11553 | Rockville Centre | New York |
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