Stereotactic Ablative Radiotherapy for Early Stage Breast Cancer

(SABER Trial)

Overseen By Zuzel Rodriguez

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Metastatic disease, ECOG 2+, Prior chest radiation, Collagenous disease, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to deliver radiation therapy to breast tumors more effectively and quickly before surgery. It focuses on early-stage breast cancer, aiming to determine the optimal radiation dose before a standard partial mastectomy (breast-conserving surgery) and axillary surgery. Known as Stereotactic Ablative Breast Radiotherapy, this method may suit women over 50 with a specific type of breast cancer that is estrogen-receptor positive, non-aggressive, and non-metastatic. Participants must be able to undergo MRI scans and agree to use birth control if they are of child-bearing potential. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future breast cancer treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this stereotactic ablative radiotherapy is safe for early stage breast cancer?

Research has shown that Stereotactic Ablative Radiotherapy (SABR) is generally safe and well-tolerated for treating various cancers, including breast cancer. Studies have found it to be an effective treatment option and have used it safely in many patients. For breast cancer, SABR can help patients remain cancer-free longer after treatment.

One study found that SABR was well-tolerated and effective, with two-thirds of patients remaining cancer-free after two years. This finding suggests that SABR is a safe and promising option for treating early-stage breast cancer. While individual experiences may differ, existing research supports the safety of SABR in a clinical setting. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Stereotactic Ablative Breast Radiotherapy (SABER) because it offers a highly targeted approach for treating early-stage breast cancer. Unlike traditional radiation therapy, which can require multiple sessions over several weeks, SABER delivers precise, high-dose radiation in just a few sessions, potentially reducing treatment time and minimizing exposure to surrounding healthy tissue. This approach not only aims to improve patient convenience but also enhances the precision of treatment, potentially leading to better outcomes with fewer side effects.

What evidence suggests that Stereotactic Ablative Breast Radiotherapy is effective for early stage breast cancer?

Research shows that Stereotactic Ablative Breast Radiotherapy (SABER), which participants in this trial may receive preoperatively, is a promising treatment for early-stage breast cancer. Studies have found it to be a safe and effective way to target tumors. One review found that using radiotherapy before surgery, such as SABER, significantly improved the time patients remained free of the disease. Additionally, SABER effectively delayed the need to change other cancer treatments, especially for certain types of breast cancer. Overall, SABER provides a strong, focused approach to treating breast cancer, with positive results reported in various studies. ^{1 2 5 6 7}

Who Is on the Research Team?

Cristiane Takita

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for women over 50 with early-stage breast cancer (T1N0M0), not spread elsewhere, confirmed by biopsy. They must have specific receptor statuses (ER/PR positive, HER2 negative) and be able to undergo MRI scans. Participants need an Oncotype or MammaPrint diagnosis before starting treatment and agree to use contraception if of childbearing potential.

Inclusion Criteria

My cancer is early stage and has not spread.

I have cancer in one area of my breast.

My breast cancer diagnosis was confirmed through a biopsy.

Exclusion Criteria

Any serious medical or psychiatric illness/condition likely in the judgment of the Investigator(s) to interfere or limit compliance with study requirements/treatment

I have had radiation treatment to my chest before.

My cancer has spread to other parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative SABER

Participants receive preoperative Stereotactic Ablative Breast Radiotherapy (SABER) to determine the most effective dose

Up to 4 weeks

Surgery

Participants undergo standard partial mastectomy and axillary surgery 4 to 6 weeks after preoperative SABER

4-6 weeks

Follow-up

Participants are monitored for treatment-related toxicity and other outcomes

13 weeks

Long-term Follow-up

Participants' health-related quality of life and cosmesis are evaluated at multiple intervals post-therapy

Up to 2.5 years

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Ablative Breast Radiotherapy

Trial Overview The study tests different doses of Stereotactic Ablative Breast Radiotherapy given in a short time before standard surgery for breast tumors. The goal is to find the most effective radiation dose that can be administered quickly.

How Is the Trial Designed?

Group I: Preoperative SABER Experimental Treatment 1 Intervention

* Experimental: Preoperative Stereotactic Ablative Breast Radiotherapy (SABER). Phase I study testing up to 4 dose levels. * Non-experimental: Participants will undergo standard partial mastectomy and axillary surgery as per discretion of treating physician 4 to 6 weeks (+ at most 1 week delay) after preoperative SABER is completed.

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

Approved in European Union as Stereotactic Ablative Radiotherapy (SABR) for:

• Primary lung cancer
• Liver cancer
• Pancreatic cancer
• Prostate cancer
• Breast cancer

Approved in United States as Stereotactic Body Radiotherapy (SBRT) for:

• Primary lung cancer
• Liver cancer
• Pancreatic cancer
• Prostate cancer
• Breast cancer

Approved in Canada as Stereotactic Ablative Body Radiotherapy (SABR) for:

• Primary lung cancer
• Liver cancer
• Pancreatic cancer
• Prostate cancer
• Breast cancer

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

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.

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]

The iSABR trial demonstrated that individualized stereotactic ablative radiotherapy (SABR) for lung tumors resulted in high local control rates, with freedom from local recurrence at 1 year ranging from 94% to 97% across different patient groups.

The trial showed a low incidence of severe toxic effects (only 5%), indicating that personalized dosing strategies can minimize risks while maintaining effective treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized Stereotactic Ablative Radiotherapy for Lung Tumors: The iSABR Phase 2 Nonrandomized Controlled Trial. Gensheimer, MF., Gee, H., Shirato, H., et al.[2023]

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 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]

In a study of 102 patients treated with stereotactic ablative radiation therapy (SABR) for early-stage non-small-cell lung cancer, a significant correlation was found between higher Biological Equivalent Doses (BED) over 300 Gy and the development of radiological changes such as organizing pneumonia and lung affectation over a 2-year follow-up.

Radiological changes were more pronounced in patients receiving BEDs greater than 300 Gy to healthy lung volumes of at least 30 cc, suggesting that these findings could inform future radiotherapy dose constraints to minimize pulmonary toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biological equivalent dose is associated with radiological toxicity after lung stereotactic ablative radiation therapy. Cases, C., Benegas, M., Sánchez, M., et al.[2023]

In a study of 500 patients treated with stereotactic ablative body radiotherapy (SABR) for stage I non-small cell lung cancer, severe chest wall pain (CWP) occurred in only 2% of patients, indicating that serious toxicity is rare with this treatment.

The study found that larger treatment volumes and closer tumor-chest wall distances were associated with increased risk of CWP and rib fractures, suggesting that careful planning of radiation doses can help minimize these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and risk factors for chest wall toxicity after risk-adapted stereotactic radiotherapy for early-stage lung cancer. Bongers, EM., Haasbeek, CJ., Lagerwaard, FJ., et al.[2022]

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) 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 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]

In a multicenter phase 3 trial involving 101 patients with inoperable stage 1 non-small-cell lung cancer, stereotactic ablative body radiotherapy (SABR) demonstrated significantly better local control compared to standard radiotherapy, with a 68% reduction in the risk of local treatment failure (hazard ratio 0.32).

SABR was associated with a similar safety profile to standard radiotherapy, showing no increase in major toxicity, making it a preferred treatment option for patients with this type of lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy versus standard radiotherapy in stage 1 non-small-cell lung cancer (TROG 09.02 CHISEL): a phase 3, open-label, randomised controlled trial. Ball, D., Mai, GT., Vinod, S., et al.[2022]

Citations

1. 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 ...

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06882499

Study Details | NCT06882499 | Stereotactic Ablative Body ... The goal of this clinical trial is to assess Stereotactic Ablative Radiotherapy (SABR) as a method to delay a change in systemic therapy in patients with ...

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. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167814021087521

Stereotactic body radiotherapy to treat breast cancer ... Our meta-analysis found that Stereotactic ablative radiotherapy can be used to treat oligometastatic BC with excellent 1- and 2-year LC and OS rates.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0960977619305909

Stereotactic ablative body radiotherapy (SABR) for bone ... We observed that SABR is feasible, well tolerated and effective in this cohort with two thirds of patients disease-free at two years.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03137693?term=AREA%5BConditionSearch%5D(ACCELERATED%20TUMOR%20FORMATION)&rank=1

Preoperative Stereotactic Ablative Body Radiotherapy (SABR) ... The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted ...