Atezolizumab + Stereotactic Radiation in Triple-negative Breast Cancer and Brain Metastasis
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ClinicalTrials.gov Identifier: NCT03483012 |
Recruitment Status :
Active, not recruiting
First Posted : March 29, 2018
Results First Posted : December 22, 2023
Last Update Posted : December 22, 2023
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Tracking Information | |||||
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First Submitted Date ICMJE | February 28, 2018 | ||||
First Posted Date ICMJE | March 29, 2018 | ||||
Results First Submitted Date ICMJE | July 7, 2023 | ||||
Results First Posted Date ICMJE | December 22, 2023 | ||||
Last Update Posted Date | December 22, 2023 | ||||
Actual Study Start Date ICMJE | May 1, 2018 | ||||
Actual Primary Completion Date | November 21, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Progression-Free Survival [ Time Frame: Assessed from the first dose of atezolizumab until the date of first documented progression according to RANO-BM or date of death from any cause, whichever came first, for a maximum of 1.5 years ] Defined as time from first dose of atezolizumab (day 1 cycle 1) to progression or death due to any cause. Progression is defined according to the bi-compartmental model proposed in the RANO-BM publication, and is defined as the first detection of radiologic progression of intracranial (per RANO-BM criteria), extracranial (per RECIST 1.1 criteria), or both or unequivocal progression of non-measurable disease in the opinion of the treating physician; with each compartment (CNS and non-CNS) assessed separately
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Original Primary Outcome Measures ICMJE |
Progression Free Survival [ Time Frame: 24 weeks ] Assessed using RANO-BM criteria
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Atezolizumab + Stereotactic Radiation in Triple-negative Breast Cancer and Brain Metastasis | ||||
Official Title ICMJE | A Phase II Study of Atezolizumab in Combination With Stereotactic Radiation for Patients With Triple-negative Breast Cancer and Brain Metastasis | ||||
Brief Summary | This research study is studying the combination of a drug called atezolizumab and a radiation procedure called stereotactic radiosurgery (SRS) as a possible treatment for triple-negative breast cancer that has spread to the brain. The interventions involved in this study are:
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Detailed Description | This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The FDA (the U.S. Food and Drug Administration) has not approved atezolizumab for this specific disease but it has been approved for other uses. Atezolizumab is a protein that affects the immune system by blocking the PD-L1 pathway. The PD-L1 pathway controls the body's natural immune response, but tumors can interrupt this pathway and partially resist or escape the immune system. By blocking the PD-L1 pathway, Atezolizumab may help the immune system identify and catch tumor cells. Stereotactic radiosurgery (SRS) is a standard procedure used to treat patients with cancer in the brain. SRS uses many precisely focused radiation beams to treat tumors. It is not surgery in the traditional sense because there's no incision. Instead, SRS uses 3-D imaging to target high doses of radiation to the affected area with minimal impact on the surrounding healthy tissue. Like other forms of radiation, SRS works by damaging the DNA of the targeted (tumor) cells. The affected cells then lose the ability to reproduce, which causes tumors to shrink. When given separately, atezolizumab and SRS, work in different ways to help stop cancer cells from growing and spreading. However, it is not known if giving atezolizumab and SRS at the same time will have a better effect than giving each treatment on its own. It is hoped that SRS treatment will damage cancer cells and make them more visible to the immune system. The researchers conducting this study are testing to see whether giving SRS with atezolizumab may boost the body's immune response to cancer, and therefore improve upon the effects of either SRS or atezolizumab given alone. In this research study, the investigators will measure the length of time that the participant receive this study intervention without the disease getting worse. The investigators will also look at how well the disease responds to atezolizumab and SRS as well as the safety of the combination. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Breast Cancer | ||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Atezolizumab + Stereotactic radiosurgery (SRS)
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
6 | ||||
Original Estimated Enrollment ICMJE |
45 | ||||
Estimated Study Completion Date ICMJE | September 30, 2025 | ||||
Actual Primary Completion Date | November 21, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03483012 | ||||
Other Study ID Numbers ICMJE | 17-519 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Nancy Lin, MD, Dana-Farber Cancer Institute | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Dana-Farber Cancer Institute | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Genentech, Inc. | ||||
Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | ||||
Verification Date | December 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |