Prospective observational study of atezolizumab plus nab-paclitaxel in patients with metastatic triple-negative breast cancer: JBCRG-C08/ATTRIBUTE
The JBCRG-C08/ATTRIBUTE (UMIN000041747) study assessed atezolizumab plus nab-paclitaxel's safety and effectiveness in a metastatic triple-negative breast cancer population, including IMpassion130-ineligible patients. The primary outcome was incidence of investigator-assessed adverse events (AEs). Safety and full analysis populations included 149 and 148 patients, respectively; 4.0% of the full analysis population had Eastern Cooperative Oncology Group performance status ≥2 and 7.4% had a history/comorbidity of autoimmune disease (AID) at baseline. AEs occurred in 96.6% of the safety analysis population; serious AEs (SAEs), in 16.8%; and immune-related AEs (irAEs), in 30.9%. irAE incidence was 45.5% in patients with a history/comorbidity of AID. Notable SAEs included pneumonitis (3.4%), diarrhoea, pyrexia, adrenal insufficiency and cardiac failure (1.3% each). Two cases of Grade 5 pneumonitis occurred. Regarding effectiveness, median progression-free survival was 5.6 months (95% confidence interval, 4.2-6.7). This first analysis found no new safety concerns with atezolizumab combination therapy, although patients with AID require careful monitoring.
Authors
- Takashi Yamanaka (ORCID: https://orcid.org/0000-0003-0117-5710)
- Naoki Niikura (ORCID: https://orcid.org/0000-0001-6732-8527)
- Tatsunori Shimoi (ORCID: https://orcid.org/0000-0002-3603-8575)
- Nobuhiro Shibata (ORCID: https://orcid.org/0000-0001-8647-5098)
- Sayuri Akiyoshi (ORCID: https://orcid.org/0000-0002-1237-5366)
- Michiko Tsuneizumi
- Shizuka Nakagawa
- M. Yamamoto
- Norikazu Masuda (ORCID: https://orcid.org/0000-0002-7302-0278)
- Masahiro Kitada (ORCID: https://orcid.org/0000-0002-9741-0510)
- Miki Yamaguchi (ORCID: https://orcid.org/0000-0002-6897-697X)
- Yumi Fujimoto
- Y. Kikawa
- Mari S. Oba
- Taizo Takahashi
- Yukinori Ozaki
- Tetsuhiko Taira
- Yutaka Yamamoto
- Naoki Hashimoto
- Hiroshi Tada
Institutions
- Kansai Medical University (JP)
- Tokai University (JP)
- Asahikawa Medical University (JP)
- Kyoto University (JP)
- Kanagawa Prefectural Hospital Organization (JP)
- National Cancer Centre Japan (JP)
- Aomori Prefectural Central Hospital (JP)
- National Hospital Organization Kyushu Cancer Center (JP)
- Tohoku University Hospital (JP)
- National Hospital Organization Hokkaido Medical Center (JP)
- National Center of Neurology and Psychiatry (JP)
- Chugai Pharma (United States) (US)
- Kumamoto University Hospital (JP)
- Saitama Cancer Center (JP)
- Shizuoka General Hospital (JP)
- The Cancer Institute Hospital (JP)
- Kagoshima Medical Center (JP)
Publication Details
- Journal
- npj Breast Cancer
- Published
- 2026-06-26
- DOI
- https://doi.org/10.1038/s41523-026-00997-y
- Primary Topic
- Cancer Immunotherapy and Biomarkers
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Chugai Pharmaceutical