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

Disqualifiers: Brain metastases, Severe co-morbidity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: Varies based on treatment plan

129 Participants Needed

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.

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. ^{1 2 3 4 5}

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. ^{2 3 6 7 8}

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. ^{2 3 6 7 8}

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.

Timeline

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

Treatment Details

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.

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 European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Stereotactic Body Radiation Therapy for:

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

Approved in United States as Stereotactic Body Radiation Therapy for:

• Early-stage lung cancer
• Liver cancer
• Spine tumors
• Pancreatic cancer
• Prostate cancer

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer. Iyengar, P., Westover, K., Timmerman, RD.[2013]

Stereotactic ablative body radiosurgery (SABR) and stereotactic body radiation therapy (SBRT) deliver high doses of radiation precisely to tumors, which may improve treatment outcomes compared to conventional low-dose radiation therapy (1.8-2Gy).

These advanced techniques not only enhance tumor ablation but also interact beneficially with biological and immunologic therapies, while incorporating methods to protect normal tissues, making them suitable for various types of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiosurgery (SABR) or Stereotactic body radiation therapy (SBRT). Folkert, MR., Timmerman, RD.[2022]

In a study of 100 patients with early-stage non-small cell lung cancer (NSCLC) treated with stereotactic ablative body radiotherapy (SABR), the 1-, 2-, and 3-year local control rates were 100%, 93.55%, and 84.33%, respectively, indicating high efficacy in tumor control.

The treatment was associated with low toxicity, with only 2% of patients experiencing Grade-3 side effects, suggesting that SABR is a safe option for patients who are inoperable or refuse surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definitive Treatment of Early-Stage Non-Small Cell Lung Cancer with Stereotactic Ablative Body Radiotherapy in a Community Cancer Center Setting. Heal, C., Ding, W., Lamond, J., et al.[2020]

Stereotactic ablative radiotherapy (SABR) has rapidly expanded in clinical use for treating various primary and metastatic tumors, demonstrating promising results in tumor control.

Despite its effectiveness, SABR can lead to serious complications, highlighting the need for strategies to reduce these risks and improve the safety of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious complications associated with stereotactic ablative radiotherapy and strategies to mitigate the risk. Lo, SS., Sahgal, A., Chang, EL., et al.[2018]

In a study of 102 patients receiving stereotactic ablative radiotherapy (SABR) for lung cancer and lung oligometastases, the three-year local control rates were 85% for primary lung cancer and 82% for metastatic lesions, which are comparable to global outcomes.

No severe toxicities (grade three) were reported, indicating that SABR is a safe treatment option, although Māori patients with primary lung cancer experienced significantly worse progression-free survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy for early stage lung cancer and lung metastases in a New Zealand population. Geary, RL., Yasin, NABH., Lin, F., et al.[2021]

Stereotactic ablative radiotherapy (SABR) is a promising treatment option for extracranial tumors, demonstrating both safety and effectiveness when applied with strict adherence to technical guidelines.

The treatment has a very narrow therapeutic window, meaning precise delivery is crucial for maximizing its benefits while minimizing risks to surrounding healthy tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical know-how in stereotactic ablative radiotherapy (SABR). Lo, SS., Foote, M., Siva, S., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy (SABR) for bone only oligometastatic breast cancer: A prospective clinical trial. [2020]

2. Ireland pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiation therapy for pulmonary metastases: Improving overall survival and identifying subgroups at high risk of local failure. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer. [2013]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiosurgery (SABR) or Stereotactic body radiation therapy (SBRT). [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Definitive Treatment of Early-Stage Non-Small Cell Lung Cancer with Stereotactic Ablative Body Radiotherapy in a Community Cancer Center Setting. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Serious complications associated with stereotactic ablative radiotherapy and strategies to mitigate the risk. [2018]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy for early stage lung cancer and lung metastases in a New Zealand population. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Technical know-how in stereotactic ablative radiotherapy (SABR). [2022]