SBRT and Imaging for Metastatic Breast Cancer
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
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
Prior Safety Data
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?This phase II trial tests how well stereotactic body radiation therapy (SBRT) works in treating patients with estrogen receptor positive (ER +) breast cancer that has spread from where it first started to other places in the body (metastatic) and has limited disease progression (oligoprogression). Currently, the standard of care for breast cancer patients with oligoprogressive disease is to change systemic therapy when progression occurs. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses (fractions) given over several days. This type of radiation therapy helps spare normal tissue and has been shown to improve survival. SBRT may kill more tumor cells and allow patients with oligoprogressive ER + metastatic breast cancer to continue taking current systemic treatment.
This trial also tests how well ER targeted positron emission tomography (PET)/ computed tomography (CT) imaging, using FES, works in identifying progressive disease in patients with ER + metastatic breast cancer. FES, a radiolabeled substance, binds to estrogen receptors and gives off radiation that can be detected by a PET scan. The PET scan, an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, FES, forms an image that shows where tumor cells with estrogen receptors can be found in the body. CT images use x-rays to provide an exact outline of organs. FES PET/CT may improve identification of progressive disease in patients with ER + metastatic breast cancer.
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 data supports the effectiveness of the treatment Stereotactic Body Radiation Therapy (SBRT) and Imaging for Metastatic Breast Cancer?
Research shows that Stereotactic Ablative Radiotherapy (SABR), a form of SBRT, is effective for treating oligometastatic breast cancer, providing good tumor control with acceptable safety. Additionally, SABR has been successful in treating other cancers, like lung cancer, especially when surgery isn't an option.
12345Is stereotactic ablative radiotherapy (SABR) using CyberKnife generally safe for humans?
Stereotactic ablative radiotherapy (SABR) using CyberKnife has been studied for various cancers, including lung, liver, and prostate cancer, and is generally considered safe, though some serious complications have been reported. Strategies to reduce these risks are important to ensure a favorable balance between benefits and potential side effects.
36789How is the treatment SBRT (Stereotactic Body Radiation Therapy) different from other treatments for metastatic breast cancer?
SBRT, also known as Stereotactic Ablative Radiotherapy (SABR), is unique because it delivers a small number of large doses of radiation precisely to the tumor, using advanced technology like the CyberKnife system. This approach is particularly beneficial for patients with tumors that move with breathing, and it aims to optimize disease control while maintaining a good quality of life.
346710Eligibility Criteria
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
I am 18 years old or older.
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
+10 more
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.
+5 more
Trial Timeline
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)
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Treatment (SBRT, FES PET/CT)Experimental Treatment7 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, Australia 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
🇦🇺 Approved in Australia as Stereotactic Body Radiation Therapy for:
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
City of Hope at Irvine LennarIrvine, CA
City of Hope Medical CenterDuarte, CA
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Who Is Running the Clinical Trial?
City of Hope Medical CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Stereotactic ablative radiation therapy for pulmonary metastases: Improving overall survival and identifying subgroups at high risk of local failure. [2021]Stereotactic ablative radiation therapy (SABR) is an emerging treatment option for patients with pulmonary metastases; identifying patients who would benefit from SABR can improve outcomes.
Stereotactic body radiotherapy to treat breast cancer oligometastases: A systematic review with meta-analysis. [2021]Stereotactic ablative radiotherapy (SABR) has been reported to be an effective treatment for oligometastatic disease from different primary cancer sites. Here we assess the effectiveness and safety of SABR for oligometastatic breast cancer patients by performing a meta-analysis.
Definitive Treatment of Early-Stage Non-Small Cell Lung Cancer with Stereotactic Ablative Body Radiotherapy in a Community Cancer Center Setting. [2020]Stereotactic ablative body radiotherapy (SABR) provides a superior non-small cell lung cancer (NSCLC) treatment option when compared to conventional radiotherapy for patients deemed inoperable or refusing surgery. This study retrospectively analyzed the rates of tumor control and toxicity following SABR treatment (Cyberknife system) of primary early-stage NSCLC in a community setting.
CyberKnife stereotactic ablative radiotherapy for lung tumors. [2022]Stereotactic ablative radiotherapy (SABR) has emerged as a promising treatment for early stage non-small cell lung cancer, particularly for patients unable to tolerate surgical resection. High rates of local tumor control have been demonstrated with acceptable toxicity and the practical advantage of a short course of treatment. The CyberKnife image-guided robotic radiosurgery system has unique technical characteristics that make it well suited for SABR of tumors that move with breathing, including lung tumors. We review the qualities of the CyberKnife platform for lung tumor SABR, and provide a summary of clinical data using this system specifically.
Stereotactic ablative body radiotherapy (SABR) for bone only oligometastatic breast cancer: A prospective clinical trial. [2020]Stereotactic ablative body radiotherapy (SABR) is an emerging noninvasive approach for the treatment of oligometastases. Limited prospective evidence is available in breast cancer.
Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. [2022]We evaluated the effectiveness and safety of stereotactic ablative radiotherapy (SABR) delivered using Cyberknife in patients with stage I non-small-cell lung cancer.
Stereotactic ablative radiotherapy for unresectable hepatocellular carcinoma patients who failed or were unsuitable for transarterial chemoembolization. [2022]The role of stereotactic ablative radiotherapy (SABR) in patients with hepatocellular carcinoma (HCC) who are refractory to or unsuitable for transarterial chemoembolization remains unclear. We examined the efficacy and safety of Cyberknife SABR and its effect on survival in this group of HCC patients.
Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. [2017]Recent clinical reports of stereotactic ablative radiotherapy (SABR) in the treatment of low-risk prostate cancer have been encouraging. Our study evaluates the efficacy and safety of SABR using the CyberKnife system for treating intermediate- to very-high-risk prostate cancer.
Serious complications associated with stereotactic ablative radiotherapy and strategies to mitigate the risk. [2018]The clinical applications of stereotactic body radiotherapy or stereotactic ablative radiotherapy (SABR) for the treatment of primary and metastatic tumours of different organ sites have been expanding rapidly in the recent decade. SABR requires advanced technology in radiotherapy planning and image guidance to deliver a highly conformal ablative dose precisely to targets (or tumours) in the body. Although this treatment modality has shown promising results with regard to tumour control, some serious complications have been observed and reported. In order to achieve a favourable therapeutic ratio, strategies to mitigate the risk of complications must be in place. This overview will summarise the reported serious complications caused by SABR and strategies to mitigate the risk will be discussed.
[Cyberknife robotic stereotactic radiotherapy: technical aspects and recent developments]. [2018]Cyberknife (Accuray Inc. Sunnyvale, USA) stereotactic body radiation therapy (SBRT) involves the delivery of a small number of large doses of radiation to a target volume using continuously evolving advanced technology. It has emerged as a novel treatment modality for cancer and modified some concepts of cancer treatment. It is indicated in early-stage primary cancer, sometimes as an alternative to surgery. It is also indicated for patients with oligometastatic disease who have relatively long survival with the aim to optimize disease control with a good quality of life. Although there remain some uncertainties regarding the radiobiology of hypofractionation, local control and tolerance have been promising. Indications are increasing under strict quality assurance programs worldwide and prospective clinical evaluation.