-
JBCRG-C08 (ATTRIBUTE)
ATezolizumab in patients with TRIple-negative Breast cancer, mUlticenter observational study for Treatment safety and Efficacy
- Status
-
No Longer Recruiting
- Objectives
-
To evaluate the safety and efficacy of treatment including atezolizumab in Japanese breast cancer patients.
- Subjects
-
Triple-negative Breast cancer
- Endpoints
-
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
-
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
-
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
-
150 cases
- Regimen
-
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
-
CHUGAI PHARMACEUTICAL CO., LTD.
- Conference Presentation
-
- Articles and Publications
-
- UMIN-ID
-
UMIN000041747
- jRCT
-
- Memo
-
- COI Disclosure
-
