-
JBCRG-C09 (OPTIMAL)
Olaparib treatment in metastatic/advanced breast cancer patients using real world data in Japan (OPTIMAL study)
- Status
-
No Longer Recruiting
- Objectives
-
To examine the efficacy and safety of olaparib in Japanese patients with real-world data.
- Subjects
-
Patients with BRCA genetic testing positive for BRCA1/2 gene mutation since July 2018, who have received olaparib (including deaths), are receiving olaparib, or will start olaparib.
- Endpoints
-
Investigator-assessed Progression Free Survival for all olaparib treatment lines (up to 1st+2nd+3rd lines) and by treatment line.
- Trial Period
-
From the date of approval by the head of the research institute up to the end of December 2029.
- Lead Principal Investigator
-
1)Hidetoshi Kawaguchi (Department of Breast Surgery, Matsuyama Red Cross Hospital)
2)Yasuaki Sagara (Department of Breast Surgery, Social medical corporation Hakuaikai, Sagara Hospital)
3) Hosoda Mitsuchika (Department of Breast Surgery, Hokkaido University Hospital)
4)Shigehira Saji (Department of Medical Oncology, Fukushima Medical University)
- Target Sample Size
-
155
- Regimen
-
Olaparib
- Source of Funding
-
AstraZeneca K.K.
- Conference Presentation
-
- Articles and Publications
-
- UMIN-ID
-
UMIN000050600
- jRCT
-
- Memo
-
- COI Disclosure
-
