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JBCRG-C08 (ATTRIBUTE)
NEW
ATezolizumab in patients with TRIple-negative Breast cancer, mUlticenter observational study for Treatment safety and Efficacy
- Status
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Now Recruiting
- Objectives
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To evaluate the safety and efficacy of treatment including atezolizumab in Japanese breast cancer patients.
- Subjects
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Triple-negative Breast cancer
- Endpoints
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The primary endpoint of this study is the incidence of adverse events as assessed by investigators.
In particular, immune-related adverse events in clinical practice are evaluated.
- Trial Period
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Enrollment period end date (Schedule): 3 years from the date of enrollment of the first study subjects or until the target number of cases is reached, whichever is earlier.
The end of the observation period: 4 years from the first enrolment date or up to 2 years from the last enrolment date, whichever is earlier.
Total study period: The period from the date of JBCRG council’s approval to the date of approval of the trial summary report.
- Lead Principal Investigator
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1) Tatsunori Shimoi
National Cancer Center Hospital
Department of Medical Oncology
2) Naoki Niikura
Tokai University School of Medicine
Department of Breast and Endocrine Surgery
- Target Sample Size
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150 cases
- Regimen
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Combination therapy with nab-paclitaxel and atezolizumab. However, since this study is an observational study under real-world clinical practice, no provisions for dosage, dosing schedule, or criteria for withdrawal, dose reduction, or discontinuation will be specified.
- Source of Funding
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CHUGAI PHARMACEUTICAL CO., LTD.
- Conference Presentation
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- Articles and Publications
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- UMIN-ID
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UMIN000041747
- jRCT
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- Memo
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- COI Disclosure
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