SBRT and Imaging for Metastatic Breast Cancer

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

Must be taking: Anti-endocrine therapy

Must not be taking: Chemotherapy, Immunotherapy

Disqualifiers: Uncontrolled illness, Liver metastases, 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: 8

Duration: 3 weeks

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a specific type of radiation therapy called stereotactic body radiation therapy (SBRT) to determine its effectiveness in treating breast cancer that has spread but is not rapidly worsening. The researchers aim to see if SBRT can help patients continue their current cancer treatments without needing to switch. The trial also evaluates a special imaging technique using PET/CT scans with F-18 16 Alpha-Fluoroestradiol (a radiotracer) to identify cancer spread more accurately. Suitable candidates for this trial have estrogen receptor-positive breast cancer that has spread to no more than four new areas outside the brain. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer therapy.

Will I have to stop taking my current medications?

You may need to stop certain medications like chemotherapy during the study, but you can continue taking anti-endocrine/hormone therapy before, during, and after the study, as decided by your doctor.

What prior data suggests that stereotactic body radiation therapy and FES PET/CT imaging are safe for treating metastatic breast cancer?

Research has shown that Stereotactic Body Radiation Therapy (SBRT) is generally safe for treating cancers that have spread. In one study, all 35 patients received standard doses without experiencing any serious side effects. SBRT effectively controlled cancer at the treated sites in 70-90% of cases.

For the imaging part of the trial, F-18 16 alpha-fluoroestradiol (FES) PET/CT scans are also considered safe. Research indicates that FES PET/CT provides a non-invasive way to scan the whole body for cancer cells that respond to estrogen, a hormone. This imaging method is already approved in the U.S. for certain breast cancer cases, supporting its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Stereotactic Body Radiation Therapy (SBRT) for metastatic breast cancer because it offers a highly precise, targeted approach that could spare healthy tissues while effectively attacking cancer cells. Unlike traditional radiation therapies that might involve larger areas and longer treatment periods, SBRT delivers high doses of radiation directly to cancer sites in just a few sessions. This technique not only aims to reduce treatment time but also minimizes potential side effects by reducing exposure to non-cancerous tissues. Furthermore, combining SBRT with advanced imaging techniques like FES PET/CT scans allows doctors to better monitor and adapt treatments, potentially improving patient outcomes.

What evidence suggests that SBRT and FES PET/CT imaging could be effective for metastatic breast cancer?

This trial will evaluate the effectiveness of stereotactic body radiation therapy (SBRT) and F-18 16 Alpha-Fluoroestradiol (FES) PET/CT imaging for metastatic breast cancer. Research has shown that SBRT can effectively treat breast cancer that has spread to a few other areas, with studies finding that patients receiving SBRT for this type of cancer can live longer. SBRT can also delay the need to change systemic treatments by over a year.

In this trial, FES PET/CT scans will identify cancer cells that respond to estrogen. These scans allow doctors to see where the cancer has spread and how it is responding to treatment, making them a valuable tool in managing breast cancer. Using FES PET/CT can improve the accuracy of detecting cancer progression, potentially leading to better treatment decisions. ^{1 2 3 6 7}

Who Is on the Research Team?

Jose G. Bazan

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with estrogen receptor positive (ER+) breast cancer that has spread but shows limited progression. Participants should be currently on systemic treatment and able to undergo high-precision radiation therapy as well as PET/CT imaging using a tracer.

Inclusion Criteria

Documented informed consent of the participant and/or legally authorized representative

Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test, If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

My cancer has worsened in 1-4 areas, as confirmed by my doctor or specific tests.

Exclusion Criteria

I've had 1 to 3 treatments for my cancer that has spread.

I haven't had cancer treatments like chemo or radiation in the last 7-14 days.

I have a serious illness that makes me unable to receive standard treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Imaging

Patients not currently taking SERMs/SERDs receive F-FES IV and undergo PET/CT scans at baseline

1 week

1 visit (in-person)

Treatment

Patients undergo 3 or 5 treatment fractions of SBRT within 3 weeks

3 weeks

3-5 visits (in-person)

Follow-up Imaging

FES PET/CT scans at 12 and 24 weeks to assess disease progression

24 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• F-18 16 Alpha-Fluoroestradiol
• Stereotactic Body Radiation Therapy

Trial Overview The study tests Stereotactic Body Radiation Therapy (SBRT) to see if it can target tumor cells effectively, allowing patients to continue their current systemic treatments. It also evaluates the use of FES PET/CT imaging in detecting where the cancer has progressed.

How Is the Trial Designed?

Group I: Treatment (SBRT, FES PET/CT) Experimental Treatment 7 Interventions

Patients currently taking SERMs/ SERDs immediately undergo 3 or 5 treatment fractions of SBRT within 3 weeks in the absence of unacceptable toxicity or evidence of \> 4 sites of disease progression. Patients not currently taking SERMs/SERDs first receive F-FES IV and undergo PET/CT scans at baseline. After baseline FES PET/CT, patients with ≤ 4 sites of progressive disease then undergo 3 or 5 treatment fractions of SBRT within 3 weeks in the absence of unacceptable toxicity or evidence of \> 4 sites of disease progression. All patients undergo FES PET/CT at 12 and 24 weeks. Patients with SD after 12 or 24 week FES PET/CT may continue standard systemic therapy. Patients with ≤ 4 sites of progressive disease after 12 or 24 week FES PET/CT may receive SBRT to additional sites in the absence of unacceptable toxicity or evidence of \> 4 sites of disease progression. All patients also undergo CT, PET/CT, or bone scans, and blood samples collection during screening and on study.

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

Approved in United States as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Approved in European Union as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Approved in Canada as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Cyberknife stereotactic body radiation therapy (SBRT) delivers high doses of radiation in fewer sessions, making it a promising alternative to surgery for early-stage primary cancers and for patients with oligometastatic disease.

Despite some uncertainties about the effects of hypofractionation, early results show good local control and patient tolerance, leading to increased use of this treatment under strict quality assurance and ongoing clinical evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cyberknife robotic stereotactic radiotherapy: technical aspects and recent developments]. Thariat, J., Marcié, S., Marcy, PY., et al.[2018]

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) using Cyberknife demonstrated high effectiveness in treating stage I non-small-cell lung cancer, with 2-year local control, progression-free, and overall survival rates of 91.9%, 61.7%, and 84.8%, respectively, based on a study of 153 patients.

The treatment was generally safe, with only 8.1% of patients experiencing severe toxicities, including one case of grade 5 radiation pneumonitis, indicating that while SABR is effective, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. Hayashi, K., Suzuki, O., Shiomi, H., et al.[2022]

Cyberknife stereotactic ablative radiotherapy (SABR) demonstrated a 71.6% objective response rate in 53 patients with unresectable hepatocellular carcinoma (HCC), indicating its efficacy as a salvage treatment when other therapies failed.

The median survival time for patients treated with SABR was 20 months, with 1- and 2-year overall survival rates of 70.1% and 45.4%, respectively, suggesting that while SABR is effective, there is a need to address issues like out-field recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy for unresectable hepatocellular carcinoma patients who failed or were unsuitable for transarterial chemoembolization. Lo, CH., Huang, WY., Lee, MS., et al.[2022]

CyberKnife stereotactic ablative radiotherapy (SABR) for treating intermediate- to very-high-risk prostate cancer showed a high 3-year biochemical relapse-free survival rate of 90.2%, indicating its efficacy in managing this condition.

The treatment was well-tolerated, with no patients experiencing severe toxicity (≥ grade 3), and only mild genitourinary and gastrointestinal side effects were reported, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. Fan, CY., Chao, HL., Huang, WY., et al.[2017]

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) 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 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 an effective treatment for early-stage non-small cell lung cancer, especially for patients who cannot undergo surgery, showing high local tumor control rates with manageable side effects.

The CyberKnife system is particularly advantageous for SABR in lung tumors due to its ability to accurately target moving tumors during breathing, enhancing treatment precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CyberKnife stereotactic ablative radiotherapy for lung tumors. Gibbs, IC., Loo, BW.[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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12110083/

The Role of [18F]FES PET/CT in Breast Cancer Management This umbrella review aims to evaluate the role of 16α-18F-fluoro-17β-estradiol ([18F]FES) PET/CT as a non-invasive imaging tool for assessing ER ...

2. tech.snmjournals.org tech.snmjournals.org/content/51/3/188

18F-FES Whole-Body Imaging Protocol for Evaluating Tumor ... 18 F-FES WB imaging noninvasively evaluates the ER status of patients with recurrent or metastatic breast cancer.

3. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/rg.220143

18F-Fluoroestradiol: Current Applications and Future ... Fluorine 18 fluoroestradiol (FES) PET/CT is approved in the United States as an adjunct to biopsy in patients with recurrent or metastatic ER-positive breast ...

4. gehealthcare.com gehealthcare.com/about/newsroom/press-releases/ge-healthcare-pharmaco-economic-study-demonstrates-adding-breast-oncology-pet-tracer-to-standard-workup-of-patients-with-metastatic-or-recurrent-breast-cancer-may-yield-beneficial-clinical-and-economic-outcomes-potentially-saving-142m-over-five-years-in-the-us?srsltid=AfmBOoozOhYgRSEHyp8J2-WQcXL4SSpmtejzMsk1W3F9xUzUznkElaEf

GE HealthCare Pharmaco-Economic Study Demonstrates ... Adding a PET/CT scan with [ 18 F]FES, a breast oncology PET tracer, may increase the accuracy of knowing the estrogen receptor (ER) status.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00602043?term=FLUOROESTRADIOL%20F-18&viewType=Table&rank=9

F-18 16 Alpha-Fluoroestradiol-Labeled Positron Emission ... This phase II trial is studying how well F-18 16 alpha- fluoroestradiol (FES) imaging works in predicting response to first-line hormone therapy in women ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2020/212155s000lbl.pdf

CERIANNA™ (fluoroestradiol F 18) - accessdata.fda.gov The uptake of fluoroestradiol F 18 is not specific for breast cancer and may occur in a variety of ER-positive tumors that arise outside of the breast, ...

7. gehealthcare.com gehealthcare.com/products/molecular-imaging-agents/cerianna?srsltid=AfmBOor48P2VNEW0YAeOMmp0vbhvRF0F871C7QlQ2mj-G_9BKBFqWRSw

Cerianna™ (fluoroestradiol F18) injection Data from a meta-analysis assessed published results comparing F18 fluoroestradiol PET and tissue assays of ER status in patients with BC.1For the primary ...