SBRT for Early Stage Breast Cancer

Overseen By Eileen Duffy, BNS OCN

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Duke University

Disqualifiers: Neoadjuvant chemotherapy, Breast implant, Lupus, 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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a focused radiation treatment called stereotactic body radiation therapy (SBRT) for women with early-stage breast cancer. Researchers aim to determine if a single, high-dose treatment before surgery can maintain good cosmetic outcomes over several years. Suitable candidates have breast cancer confined to a small area, have not received prior breast radiation, and are estrogen receptor positive. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What prior data suggests that this protocol is safe for early stage breast cancer?

Research has shown that stereotactic body radiation therapy (SBRT) is safe and effective for treating various cancers, including breast cancer. Studies indicate that patients generally tolerate SBRT well, with few serious side effects. For instance, one study found that using SBRT for breast cancer was safe, with manageable side effects.

Although this trial is in an early stage and primarily focuses on safety, previous studies provide some reassurance. Since SBRT has already been tested for breast cancer and demonstrated safety in other cancers, this bolsters confidence. While each patient may respond differently, overall findings suggest that SBRT is a promising and well-tolerated treatment option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about stereotactic body radiotherapy (SBRT) for early-stage breast cancer because it offers a unique approach compared to traditional treatments like whole-breast irradiation. SBRT delivers a single, high-dose radiation treatment with pinpoint precision, minimizing exposure to surrounding healthy tissue. This targeted method could reduce the overall treatment time significantly and may lead to fewer side effects, making it a potentially more convenient and patient-friendly option. Additionally, the ability to proceed to surgery shortly after could streamline the overall treatment process, offering potential improvements in patient outcomes.

What evidence suggests that SBRT is effective for early stage breast cancer?

Research has shown that preoperative radiotherapy, such as SBRT (Stereotactic Body Radiation Therapy), can significantly improve the chances of remaining disease-free in early-stage breast cancer. In this trial, participants will receive a single fraction of 21Gy of stereotactic radiotherapy before surgery. SBRT targets the tumor with precise, high doses of radiation, potentially reducing the need for more invasive treatments. Previous studies found that SBRT can delay disease progression by over a year. Although typically used for more advanced cases, its application in early-stage breast cancer appears promising. These findings suggest that SBRT could be an effective pre-surgery treatment option for early-stage breast cancer. ^{3 5 6 7 8}

Who Is on the Research Team?

Rachel Blitzblau, MD PhD

Principal Investigator

Duke Health

Are You a Good Fit for This Trial?

This trial is for women aged 60+ or those 50-59 with a low Oncotype score, diagnosed with early-stage breast cancer (ER+, HER2-) that's less than or equal to 2cm. They must have normal blood counts, be candidates for breast preservation, and agree to use contraception if of child-bearing potential. It excludes HER2 positive patients, those who've had neoadjuvant chemotherapy, pregnant women, and anyone unable to undergo the treatment due to medical conditions.

Inclusion Criteria

My cancer is estrogen receptor positive and HER2 negative.

Tissue samples from other hospitals will be checked again to confirm the diagnosis.

Your white blood cell count, hemoglobin level, and platelet count must be within certain ranges when you agree to participate in the study.

Exclusion Criteria

My cancer is HER2 positive.

I did not have a clip placed during my biopsy and I do not want one now.

Your treatment plan cannot be followed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Radiotherapy

Participants receive a single fraction of 21Gy stereotactic radiotherapy before surgery

1 day

1 visit (in-person)

Surgery

Participants undergo surgery following radiotherapy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including cosmesis and gene expression assessments

3 years

Regular visits (in-person and virtual) at designated timepoints

Long-term Follow-up

Annual clinical examination combined with breast imaging to assess local control

5-10 years

What Are the Treatments Tested in This Trial?

Interventions

• SBRT

Trial Overview The study tests preoperative single-fraction radiotherapy delivering 21Gy in one session for early-stage breast cancer patients. The goal is to assess cosmetic outcomes using the NRG cosmesis scale at various intervals post-treatment up to three years.

How Is the Trial Designed?

Group I: Single arm 21Gy stereotactic radiotherapy Experimental Treatment 1 Intervention

Subjects will receive a single fraction of 21Gy of stereotactic radiotherapy before proceeding to surgery.

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

Approved in United States as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors

Approved in European Union as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors
• Bone metastases

Approved in Canada as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors

Approved in Japan as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Gateway for Cancer Research

Collaborator

Trials

47

Recruited

2,500+

Published Research Related to This Trial

Stereotactic body radiotherapy (SBRT) is effective for treating early-stage non-small cell lung cancer (NSCLC) in patients who cannot undergo surgery, showing good outcomes and low toxicity for tumors located in the periphery.

However, the risk of severe toxicity increases for tumors near critical structures like the bronchial tree or mediastinum, highlighting the importance of careful dose-fractionation planning in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An optimal dose-fractionation for stereotactic body radiotherapy in peripherally, centrally and ultracentrally located early-stage non-small lung cancer. Zarębska, I., Harat, M.[2023]

In a study of 40 patients with central and ultracentral non-small cell lung cancer (NSCLC) treated with stereotactic ablative radiotherapy (SABR), those with ultracentral tumors experienced worse overall survival (OS) and progression-free survival (PFS) compared to those with central tumors, indicating a need for careful consideration in treatment planning.

The incidence of severe treatment-related toxicities (grade ≥3) was higher in the ultracentral group, with 12.5% of patients experiencing significant complications, including severe bronchial obstruction and esophageal perforation, highlighting the potential risks associated with SABR in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes in patients with central and ultracentral non-small cell lung cancer treated with stereotactic body radiotherapy: single-institution experience. Song, X., Zhao, L., Jiang, N., et al.[2023]

Stereotactic ablative radiotherapy (SABR) shows high effectiveness for oligometastatic breast cancer, achieving local control rates of 97% at 1 year and 90% at 2 years, based on a meta-analysis of 10 studies involving 467 patients.

SABR is associated with a low toxicity rate, with only 4.1% of patients experiencing grade 2 or 3 side effects, indicating it is a safe treatment option for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy to treat breast cancer oligometastases: A systematic review with meta-analysis. Viani, GA., Gouveia, AG., Louie, AV., 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]

Stereotactic ablative body radiotherapy (SABR) is now the standard treatment for early-stage non-small-cell lung cancer (NSCLC) in patients who cannot undergo surgery, highlighting its efficacy in this patient population.

The review also discusses the safety profile of SABR, including reported toxicity rates, and explores its potential use in combination with other therapies for improved outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of outcomes following stereotactic ablative radiotherapy in the treatment of early-stage primary lung cancer. Murray, P., Franks, K., Hanna, GG.[2022]

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]

The introduction of stereotactic ablative body radiotherapy (SABR) for stage I non-small-cell lung cancer (NSCLC) at a Scottish cancer center has led to improved median survival rates, increasing from 32.5 months before SABR was available to 48.8 months after its establishment.

SABR has not only improved survival outcomes but also increased the proportion of patients receiving radical therapy, particularly among younger and healthier patients, indicating its effectiveness as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Impact of SABR on Stage I Non-Small-Cell Lung Cancer Outcomes at a Scottish Cancer Centre. Stares, M., Lewis, G., Vallet, M., et al.[2023]

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 body radiation therapy (SBRT) is a preferred treatment for early-stage non-small cell lung cancer (NSCLC) patients who cannot undergo surgery, but accurate lymph node staging is crucial for optimal patient selection.

Current staging methods like PET/CT and EBUS have limited sensitivity in detecting lymph node metastases, which can lead to undetected cancer spread and poorer outcomes; thus, invasive staging procedures are often necessary to improve detection and potentially enhance survival with adjuvant therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Undetected lymph node metastases in presumed early stage NSCLC SABR patients. Cerra-Franco, A., Diab, K., Lautenschlaeger, T.[2017]

Stereotactic ablative body radiotherapy (SABR) is a significant advancement in radiotherapy that has been shown to improve tumor control and overall survival in patients with lung tumors.

The review highlights the current evidence supporting the efficacy of SABR for both primary and secondary lung tumors, along with ongoing trials that may further validate its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy (SABR) for primary and secondary lung tumours. Goldsmith, C., Gaya, A.[2022]

The TROG 13.01/ALTG 13.001 clinical trial is investigating the safety and efficacy of single versus multi-fraction stereotactic ablative body radiotherapy (SABR) for lung tumors in 84 patients with up to three metastases, aiming to determine the best treatment approach for pulmonary oligometastases.

The study will compare a single high dose of 28Gy to a total of 48Gy delivered in four fractions, assessing not only safety but also quality of life, survival rates, and potential cost implications of each treatment method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised phase II trial of Stereotactic Ablative Fractionated radiotherapy versus Radiosurgery for Oligometastatic Neoplasia to the lung (TROG 13.01 SAFRON II). Siva, S., Kron, T., Bressel, M., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11295558/

Advances in breast cancer treatment: a systematic review of ... A growing number of reports indicate that preoperative radiotherapy for early-stage breast cancer significantly improves disease-free survival ( ...

2. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-024-02497-4

Advances in breast cancer treatment: a systematic review of ... A growing number of reports indicate that preoperative radiotherapy for early-stage breast cancer significantly improves disease-free survival ( ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0960977625005636

Impact of stereotactic body radiation therapy on systemic ... SBRT is widely used in oligometastatic breast cancer despite limited evidence. •. SBRT delayed systemic therapeutic line change by over 1 year in our cohort. •.

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

A Phase II Prospective Multicenter Trial This study suggests that SABR can help delay the need to change systemic therapy in patients with estrogen receptor–positive, human epidermal ...

5. clinicaltrials.gov clinicaltrials.gov/show/NCT03295916

Stereotactic Body Radiotherapy for Patients With Breast ... The purpose of this study is to evaluate feasibility to treat metachronous multi-site breast cancer oligometastasis with stereotactic body radiotherapy (SBRT) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5816843/

Establishing the Role of Stereotactic Ablative Body ... Stereotactic ablative body radiotherapy in breast cancer is appealing and has been shown to be a safe and effective definitive treatment option in many tumor ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1896112624000026

Stereotactic body radiation therapy (SBRT) for the ... Between 2015 and 2019, 13 non-surgical candidates with 14 lesions were treated with SBRT for primary breast cancer. In 4 cases, SBRT was used after whole breast ...

8. redjournal.org redjournal.org/article/S0360-3016(24)00508-X/fulltext

Safety and Efficacy of Stereotactic Body Radiation Therapy ... We sought to evaluate the toxicity and efficacy of stereotactic body radiation therapy (SBRT) for ultracentral thoracic tumors at our institution.