Atezolizumab in patients with triple-negative breast cancer, multicenter observational study for treatment safety and efficacy (JBCRG-C08)

Atezolizumab in patients with triple-negative breast cancer, multicenter observational study for treatment safety and efficacy (JBCRG-C08) - JBCRG-C08 (ATTRIBUTE)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000041747

Enrollment

150

Registered

2020-10-01

Start date

2020-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Triple-negative Breast cancer

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) >=20 years old 2) Inoperable or recurrent breast cancer with PD-L1-positive, hormone receptor-negative and HER2-negative 3)the patient who is planned to receive chemotherapy that includes atezolizumab as a clinical practice under national health insurance 4)Without history of hypersensitivity to the components of atezolizumab 5) Less than 2 regimens of systemic chemotherapy for inoperable or recurrent breast cancer 6) Written agreement to the enrollment for this study

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
1) Overall Survival: OS 2) Overall Survival Rate (12,18,24 months) 3) Progression Free Survival: PFS 4) Progression Free Survival Rate (6,12,18,24 months) 5) Time to Treatment Failure: TTF 6) Treatment Success Rate (6,12,18,24 months) 7) Overall Response Rate: ORR 8) Duration of Response: DOR 9) Time to Response: TTR 10) Clinical Benefit Rate: CBR 11) Tumor Shrinkage Rate	—

Countries

Japan

Contacts

Public ContactJun Fukase

Japan Breast Cancer Research Group (JBCRG) Head office

JBCRG-QAG@jbcrg.jp03-6264-8873

Outcome results