NCT07053085 A Study of Surgery and Radiotherapy in People With Breast Cancer
| NCT ID | NCT07053085 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Metastatic Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 178 participants |
| Start Date | 2025-09-17 |
| Primary Completion | 2029-09-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 178 participants in total. It began in 2025-09-17 with a primary completion date of 2029-09-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Lior Braunstein, MD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT07053085 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07053085 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07053085 currently recruiting?
Yes, NCT07053085 is actively recruiting participants. Contact the research team at braunstl@mskcc.org for enrollment information.
Where is the NCT07053085 trial being conducted?
This trial is being conducted at Basking Ridge, United States, Middletown, United States, Montvale, United States, Commack, United States and 3 additional locations.
Who is sponsoring the NCT07053085 clinical trial?
NCT07053085 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Lior Braunstein, MD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 178 participants.
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