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Surgery or High-Dose Radiation for Metastatic Breast Cancer

Phase 2 & 3
Waitlist Available
Led By Steven Chmura
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Known estrogen, progesterone, and HER2 status of either primary tumor or metastasis; estrogen, progesterone and HER2 status of metastasis preferred for stratification
Pathologically confirmed metastatic breast cancer
Must not have
Pathologic evidence of active primary disease or local/regional breast tumor recurrence at the time of registration
Metastases located within 3 cm of the previously irradiated structures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to last follow-up. follow-up schedule: 3 mos after randomization and every 3 months to 24 months and then annually. maximum follow-up at time of analysis was 63 months.
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether adding stereotactic radiosurgery and/or surgery to standard of care therapy is more effective in treating patients with limited metastatic breast cancer.

Who is the study for?
This trial is for breast cancer patients with limited metastasis (1-2 untreated locations) who have started or plan to start first-line systemic therapy. Eligible participants must have a confirmed diagnosis, known hormone receptor status, controlled primary tumor site, and good performance status. They should not have more than four metastases larger than 5 cm in size or any brain metastases.
What is being tested?
The study compares standard care alone versus standard care with added stereotactic body radiotherapy (SBRT) or surgery for treating limited metastatic breast cancer. The goal is to see if adding precise high-dose radiation or surgery can improve survival compared to the usual approach of relieving symptoms.
What are the potential side effects?
Potential side effects include those from SBRT like skin irritation, fatigue, and localized pain; surgical risks involve bleeding, infection, and anesthesia complications. Standard care therapies also carry their own set of possible side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I know my cancer's estrogen, progesterone, and HER2 status.
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My breast cancer has spread to other parts of my body.
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All my cancer spots can be treated with targeted therapy or surgery.
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My largest cancer spread is 5 cm or smaller.
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I am receiving or planning to receive my first treatment for advanced breast cancer.
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My primary cancer site is under control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My breast cancer is currently active or has come back in the same area.
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My cancer has spread to areas close to where I had radiation before.
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I have fluid buildup that's been confirmed to be cancerous.
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My cancer has spread, and the new tumors' edges are not clear.
Select...
I have had radiation for cancer that has spread, to join this study.
Select...
My cancer has spread to my brain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to last follow-up. follow-up schedule: 3 mos after randomization and every 3 months to 24 months and then annually. maximum follow-up at time of analysis was 63 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to last follow-up. follow-up schedule: 3 mos after randomization and every 3 months to 24 months and then annually. maximum follow-up at time of analysis was 63 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Survival (Phase III)
Progression-free Survival (Phase II)
Secondary study objectives
Number of Patients by Highest Grade Adverse Event Reported
Percentage of Participants With New Metastases
Percentage of Participants With Treated Metastasis Progression on the SOC + Ablation Arm
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of Care + AblationExperimental Treatment2 Interventions
Standard of care systemic therapy plus ablation of all metastases by stereotactic body radiotherapy or surgery at the discretion of the treating physician.
Group II: Standard of Care (SOC)Active Control1 Intervention
Standard of care systemic therapy at the discretion of the treating physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiotherapy
2017
Completed Phase 2
~220
Surgery
2000
Completed Phase 3
~2490

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,886 Previous Clinical Trials
41,020,808 Total Patients Enrolled
947 Trials studying Breast Cancer
1,545,613 Patients Enrolled for Breast Cancer
NRG OncologyLead Sponsor
237 Previous Clinical Trials
102,645 Total Patients Enrolled
9 Trials studying Breast Cancer
11,639 Patients Enrolled for Breast Cancer
Steven ChmuraPrincipal InvestigatorNRG Oncology
2 Previous Clinical Trials
46 Total Patients Enrolled

Media Library

Stereotactic Body Radiotherapy Clinical Trial Eligibility Overview. Trial Name: NCT02364557 — Phase 2 & 3
Breast Cancer Research Study Groups: Standard of Care (SOC), Standard of Care + Ablation
Breast Cancer Clinical Trial 2023: Stereotactic Body Radiotherapy Highlights & Side Effects. Trial Name: NCT02364557 — Phase 2 & 3
Stereotactic Body Radiotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT02364557 — Phase 2 & 3
~12 spots leftby Oct 2025
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