Clinical Trials

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

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