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Radiation Therapy
SBRT for Metastatic Breast and Lung Cancer
Phase 2
Waitlist Available
Led By C. Jillian Tsai, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- Triple negative breast cancer TNBC (ER <1%, PR <1%, her-2-neu 0- 1+ by IHC or FISH-negative or as determined by MD discretion)
- NSCLC (without known EGFR mutation or ALK/ROS1 rearrangement)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Awards & highlights
Study Summary
This trial is testing a new cancer treatment to see if it can help people live longer by stopping their disease from getting worse.
Who is the study for?
This trial is for adults with certain types of metastatic breast or lung cancer that's started to progress. Participants must have had at least one prior systemic therapy and can safely receive radiation. They shouldn't be pregnant, have serious conditions like scleroderma, or uncontrolled medical issues.Check my eligibility
What is being tested?
The study tests if stereotactic body radiation therapy (SBRT) can extend the time before disease worsens in patients whose metastatic cancer has begun growing again. It compares SBRT with standard care treatments in a randomized setting.See study design
What are the potential side effects?
Potential side effects of SBRT may include skin reactions, fatigue, short-term pain at the treatment site, nausea, and rarely more severe complications such as damage to nearby organs depending on the area treated.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is triple negative.
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My lung cancer does not have EGFR, ALK, or ROS1 mutations.
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I have a history of autoimmune disease.
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My cancer has spread to more than 5 places, but only up to 5 are getting worse.
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I am 18 years old or older.
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My NSCLC has worsened despite first-line treatment targeting EGFR, ALK, or ROS1.
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My cancer has spread to other parts of my body and this has been confirmed by tests.
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I have moderate to severe numbness, tingling, or pain in my hands or feet.
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I do not have active liver disease, hepatitis, or cirrhosis.
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I am not on long-term steroids or any drugs that weaken my immune system.
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I am currently on antibiotics for an infection.
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I have no more than 5 worsening cancer spots in one organ outside my brain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival
Secondary outcome measures
Overall survival
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1: Early Stereotactic Body Radiotherapy/SBRTExperimental Treatment1 Intervention
SBRT to all oligoprogressive sites
Group II: Arm 2:Standard of CareActive Control1 Intervention
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,513 Total Patients Enrolled
203 Trials studying Breast Cancer
81,137 Patients Enrolled for Breast Cancer
C. Jillian Tsai, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Nadeem Riaz, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer is triple negative.My lung cancer does not have EGFR, ALK, or ROS1 mutations.I can receive emergency radiation for symptoms like cord compression before joining the study.I have had radiation therapy near my current cancer sites and can join.I have a history of autoimmune disease.My cancer has spread to more than 5 places, but only up to 5 are getting worse.I am 18 years old or older.My NSCLC has worsened despite first-line treatment targeting EGFR, ALK, or ROS1.You have HIV, hepatitis B or C, or active hepatitis A.I cannot receive radiotherapy due to serious health conditions like ataxia-telangiectasia or scleroderma.My cancer has spread to other parts of my body and this has been confirmed by tests.I have moderate to severe numbness, tingling, or pain in my hands or feet.My doctor may decide if I need a biopsy of the cancer spread before joining.I do not have active liver disease, hepatitis, or cirrhosis.My cancer has spread to no more than 5 areas, as confirmed by scans.I am not on long-term steroids or any drugs that weaken my immune system.I am currently on antibiotics for an infection.You have a permanent pacemaker.You have had a previous organ transplant or a weak immune system from birth.All my cancer growth areas can be safely treated.I have previously received immunotherapy.My cancer has spread to the lining of my brain and spinal cord.My high-risk breast cancer has worsened despite hormone or systemic therapy.I do not have any uncontrolled medical conditions or recent heart issues.My cancer has spread to other parts of my body with no limit on the number.I have undergone at least one round of systemic therapy for my condition.I have no more than 5 worsening cancer spots in one organ outside my brain.Your heart's electrical activity is too slow or irregular.I have brain metastases treated with targeted radiation before joining the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1: Early Stereotactic Body Radiotherapy/SBRT
- Group 2: Arm 2:Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential dangers are associated with Sterotactic Body Radiotherapy/SBRT treatments?
"Previous data suggests Sterotactic Body Radiotherapy/SBRT is relatively safe, so it has been rated a 2 on our scale. This Phase 2 trial indicates that while safety has been established, efficacy remains unverified."
Answered by AI
Are there significant numbers of medical facilities in the US administering this research?
"Presently, 9 sites are actively enrolling patients for this therapeutic trial. The locations spread across Montvale, Rockville Centre and Basking Ridge with 6 additional centres. It is recommended that participants select the nearest site to minimize travelling needs."
Answered by AI
Are there any openings in this experiment to enroll participants?
"According to clinicaltrials.gov, this study is no longer open for recruitment. It was first advertised on January 16th 2019 and last updated on July 26th 2022, but there are a plethora of other trials actively seeking patients at the moment (4312)."
Answered by AI
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