Surgery or High-Dose Radiation for Metastatic Breast Cancer

No longer recruiting at 175 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding high-dose radiation or surgery to standard treatments can better manage breast cancer that has spread to one or two other parts of the body. Researchers aim to determine if these additional treatments can more effectively target and remove cancer cells compared to standard treatments alone. The trial seeks participants diagnosed with metastatic breast cancer that has spread to specific areas like the lungs, bones, or liver, with up to four treatable metastatic sites. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group, offering participants a chance to contribute to potentially groundbreaking advancements in cancer care.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that stereotactic body radiotherapy (SABR) is safe for patients with metastatic breast cancer. Studies have found that SABR is non-invasive and does not cause severe side effects. It accurately targets the tumor while protecting healthy tissues. For example, in one study, patients treated with standard doses did not experience serious side effects.

Stereotactic radiosurgery (SRS) is also considered safe. It has been effective in treating breast cancer that has spread to the brain, with a low risk of side effects. This method focuses radiation precisely on the tumor, reducing harm to healthy brain tissue.

The evidence on surgery is mixed. Some studies suggest surgery can help certain patients live longer without significantly increasing the risk of serious side effects. However, the benefits can vary for each person, and not all research agrees on its impact on overall survival.

In this trial, all treatments being tested are in advanced stages, indicating some confidence in their safety. Prospective participants should discuss the possible risks and benefits with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using stereotactic body radiotherapy (SBRT) and surgery for metastatic breast cancer because these treatments specifically target cancerous areas with high precision. Unlike traditional chemotherapy or hormone therapies that affect the whole body, SBRT delivers high doses of radiation directly to the tumors with minimal impact on surrounding healthy tissue. Additionally, surgery remains a powerful option for directly removing visible tumors, which can be highly effective when paired with systemic therapy. This targeted approach is promising because it could potentially improve outcomes and quality of life for patients by focusing on eradicating cancer cells more accurately and efficiently.

What evidence suggests that this trial's treatments could be effective for metastatic breast cancer?

Research has shown that stereotactic body radiotherapy (SABR) effectively treats breast cancer that has spread to other parts of the body. It controls cancer in the treated area and can improve survival rates. Stereotactic radiosurgery (SRS) shows promise for cancer that has spread to the brain, demonstrating good results and safety. Some participants in this trial will receive standard care plus ablation of all metastases through either SABR or surgery. Studies suggest that surgery for metastatic breast cancer can increase survival by 30% to 50%. Overall, combining these treatments with standard care may lead to better outcomes for patients with limited spread of breast cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

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.

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 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?

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+

Published Research Related to This Trial

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]

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 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 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]

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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38575431/

Treatment Outcomes of Stereotactic Ablative Body ... This study confirmed that SABR was a safe, non-invasive treatment option for patients with extracranial OM and OP diseases originated from primary breast ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0936655524001092

Treatment Outcomes of Stereotactic Ablative Body ... This study reported SABR treatment outcomes for multisite OM and OP diseases originating from metastatic breast cancer · It showed modest local control and post- ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11609137/

Treatment of metastatic breast cancer by stereotactic body ... Patients administered local ablative radiotherapy (SBRT/SRS) for oligometastases have better overall survival than those treated for oligoprogression.

4. thegreenjournal.com thegreenjournal.com/article/S0167-8140(21)08752-1/abstract

Stereotactic body radiotherapy to treat breast cancer ... Stereotactic ablative radiotherapy (SABR) has been reported to be an effective treatment for oligometastatic disease from different primary cancer sites.

5. ascopubs.org ascopubs.org/doi/10.1200/OA-25-00031

A Phase II Prospective Multicenter Trial Median PFS was 5.2 months (95% CI, 3.1 to 6.8), with 11 (34%) and two (6%) of patients receiving second and third courses of SABR, respectively.

6. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2778658

Evaluation of Safety of Stereotactic Body Radiotherapy for ... Standard doses were safe in all 35 evaluable patients, with a median of 3 metastases; there were no protocol-defined dose-limiting toxicities, ...