129 Participants Needed

Surgery or High-Dose Radiation for Metastatic Breast Cancer

Recruiting at 169 trial locations
Age: 18+
Sex: Female
Trial Phase: Phase 2 & 3
Sponsor: NRG Oncology
Must be taking: Chemotherapy, Hormonal therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that standard systemic therapy for metastatic breast cancer must be given or planned, so you may need to continue certain treatments. It's best to discuss your specific medications with the trial team.

Is stereotactic ablative radiotherapy (SABR) generally safe for humans?

Stereotactic ablative radiotherapy (SABR) has been used safely in treating various cancers, but some serious complications have been reported. Strategies to reduce these risks are important to ensure safety.12345

How is the treatment Stereotactic Body Radiotherapy different from other treatments for metastatic breast cancer?

Stereotactic Body Radiotherapy (SBRT) is unique because it delivers high doses of radiation with precision to target tumors directly, often in fewer sessions compared to traditional radiation therapy. This noninvasive approach can spare normal tissue and is used for various cancers, including breast cancer with limited metastases, offering a potential alternative to surgery.23678

What data supports the effectiveness of this treatment for metastatic breast cancer?

Stereotactic ablative body radiotherapy (SABR) has shown effectiveness in treating non-small cell lung cancer and pulmonary metastases by delivering high doses of radiation precisely to tumors, which may suggest potential benefits for metastatic breast cancer as well.23678

Who Is on the Research Team?

SJ

Steven J Chmura

Principal Investigator

NRG Oncology

Are You a Good Fit for This Trial?

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.
See 13 more

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.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard of care therapy with or without stereotactic body radiotherapy and/or surgical ablation

Varies based on treatment plan
Weekly visits during SBRT, otherwise as per standard care

Follow-up

Participants are monitored for progression-free survival and overall survival

63 months
Every 3 months up to 24 months, then every 6 months up to 5 years, then annually

What Are the Treatments Tested in This Trial?

Interventions

  • Laboratory Biomarker Analysis
  • Stereotactic Body Radiotherapy
  • Stereotactic Radiosurgery
  • Surgery
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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of Care + AblationExperimental Treatment2 Interventions
Group II: Standard of Care (SOC)Active Control1 Intervention

Stereotactic Body Radiotherapy is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Stereotactic Body Radiation Therapy for:
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Approved in United States as Stereotactic Body Radiation Therapy for:
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Approved in Canada as Stereotactic Body Radiation Therapy for:
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Approved in Japan as Stereotactic Body Radiation Therapy for:

Find a Clinic Near You

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+

Published Research Related to This Trial

Stereotactic ablative body radiotherapy (SABR) is a feasible and well-tolerated treatment for patients with bone-only oligometastatic breast cancer, with 80% of patients successfully receiving treatment and no severe (grade 3 or 4) toxicities reported.
The treatment showed promising efficacy, with a 100% local progression-free survival (LPFS) and 67% distant progression-free survival (DPFS) at two years, suggesting that SABR could be a viable option for this patient group.
Stereotactic ablative body radiotherapy (SABR) for bone only oligometastatic breast cancer: A prospective clinical trial.David, S., Tan, J., Savas, P., et al.[2020]
Stereotactic ablative radiation therapy (SABR) was found to be effective for treating pulmonary metastases, with a median follow-up of 23 months showing improved overall survival (OS) for patients with 3 or fewer metastases compared to those with more (74.2% vs. 59.3% at 24 months).
Patients with less responsive primary tumors (like adrenal or pancreatic cancers) had higher local failure rates, suggesting that higher doses of SABR or surgical options may be necessary for these cases to improve treatment outcomes.
Stereotactic ablative radiation therapy for pulmonary metastases: Improving overall survival and identifying subgroups at high risk of local failure.Pasalic, D., Lu, Y., Betancourt-Cuellar, SL., et al.[2021]
Stereotactic ablative radiotherapy (SABR) is an effective treatment for early-stage non-small cell lung cancers (NSCLCs) that are medically inoperable, providing local control and toxicity levels comparable to surgical resection.
SABR is gaining interest as a noninvasive treatment option for patients with borderline resectable lung cancers, although further randomized studies are needed to evaluate its survival benefits in operable patients.
Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer.Iyengar, P., Westover, K., Timmerman, RD.[2013]

Citations

Stereotactic ablative body radiotherapy (SABR) for bone only oligometastatic breast cancer: A prospective clinical trial. [2020]
Stereotactic ablative radiation therapy for pulmonary metastases: Improving overall survival and identifying subgroups at high risk of local failure. [2021]
Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer. [2013]
Stereotactic ablative body radiosurgery (SABR) or Stereotactic body radiation therapy (SBRT). [2022]
Definitive Treatment of Early-Stage Non-Small Cell Lung Cancer with Stereotactic Ablative Body Radiotherapy in a Community Cancer Center Setting. [2020]
Serious complications associated with stereotactic ablative radiotherapy and strategies to mitigate the risk. [2018]
Stereotactic ablative radiotherapy for early stage lung cancer and lung metastases in a New Zealand population. [2021]
Technical know-how in stereotactic ablative radiotherapy (SABR). [2022]
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