Surgery or High-Dose Radiation for Metastatic Breast Cancer

Recruiting at 169 trial locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: NRG Oncology

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This randomized phase II/III trial studies how well standard of care therapy with stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy alone in treating patients with breast cancer that has spread to one or two locations in the body (limited metastatic) that are previously untreated. Standard of care therapy comprising chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of tumor cells. Radiation therapy and/or surgery is usually only given with standard of care therapy to relieve pain; however, in patients with limited metastatic breast cancer, stereotactic radiosurgery, also known as stereotactic body radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue and surgery may be able to effectively remove the metastatic tumor cells. It is not yet known whether standard of care therapy is more effective with stereotactic radiosurgery and/or surgery in treating limited metastatic breast cancer.

Research Team

Steven J Chmura

Principal Investigator

NRG Oncology

Eligibility Criteria

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.

Inclusion Criteria

I know my cancer's estrogen, progesterone, and HER2 status.

Your hemoglobin level is at least 8.0 grams per deciliter.

You had a blood test in the last 60 days before joining the study.

Exclusion Criteria

I have been cancer-free for at least 3 years, except for non-melanoma skin cancer.

You have a serious ongoing health problem.

My breast cancer is currently active or has come back in the same area.

Treatment Details

Interventions

• Laboratory Biomarker Analysis (Other)
• Stereotactic Body Radiotherapy (Radiation)
• Stereotactic Radiosurgery (Radiation)
• Surgery (Other)

Trial Overview 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.

Participant Groups

Group I: Standard of Care + Ablation Experimental Treatment 2 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 Control 1 Intervention

Standard of care systemic therapy at the discretion of the treating physician.

Stereotactic Body Radiotherapy is already approved in Canada, Japan for the following indications:

Approved in Canada as Stereotactic Body Radiation Therapy for:

• Lung cancer
• Liver cancer
• Spine tumors
• Pancreatic cancer
• Prostate cancer

Approved in Japan as Stereotactic Body Radiation Therapy for:

• Lung cancer
• Liver cancer
• Spine tumors
• Pancreatic cancer
• Prostate cancer

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials

242

Recruited

105,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+