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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

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

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival (Phase III)

Progression-free Survival (Phase II)

Secondary outcome measures

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

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

Surgery

2000

Completed Phase 3

~2550

Stereotactic Body Radiotherapy

2017

Completed Phase 2

~220

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,024 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

NRG OncologyLead Sponsor

231 Previous Clinical Trials

100,723 Total Patients Enrolled

9 Trials studying Breast Cancer

11,638 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being signed up for this experiment currently?

"The most recent update on clinicaltrials.gov suggests that this study is not recruiting patients at the moment. This particular trial was first posted on December 24th, 2014 but was updated as recently as October 4th, 2020. There are 4,903 other clinical trials that are still recruiting patients."

Answered by AI