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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.

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I have had radiation for cancer that has spread, to join this study.

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My cancer has spread to my brain.

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

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