UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050600 |
|---|---|
| Receipt number | R000057633 |
| Scientific Title | Olaparib treatment in metastatic/advanced breast cancer patients using real world data in Japan (OPTIMAL study) |
| Date of disclosure of the study information | 2023/03/15 |
| Last modified on | 2025/03/21 17:13:25 |
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Basic information
Public title
Efficacy and safety of Olaparib treatment for advanced or recurrent breast cancer (OPTIMAL study)
Acronym
JBCRG-C09 (OPTIMAL study)
Scientific Title
Olaparib treatment in metastatic/advanced breast cancer patients using real world data in Japan (OPTIMAL study)
Scientific Title:Acronym
JBCRG-C09 (OPTIMAL study)
Region
| Japan |
Condition
Condition
HER2 negative advanced or recurrence (metastatic) breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of Olaparib in Japanese patients using real-world data.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Investigator-assessed Progression Free Survival (investigator-assessed PFS) for all Olaparib treatment lines (up to 1st+2nd+3rd lines) and by treatment line.
Key secondary outcomes
1) Time to treatment discontinuation for all Olaparib treatment lines (up to 1st+2nd+3rd lines) and by treatment line.
2) Investigation of clinicopathological factors affecting investigator-assessed PFS of Olaparib.
3) Overall survival for the entire Olaparib treatment group (Overall Survival:OS)
4) Analysis of clinicopathological factors that affect OS.
5) Olaparib treatment line and OS from progression/relapse
6) Incidence rate of Grade 3 or higher anemia, nausea, and vomiting by line of Olaparib treatment
7) Percentage of blood transfusions by line of Olaparib treatment.
8) Percentage of Olaparib dose reduction by line of treatment.
Exploratory analysis will also be conducted.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who are 20 years of age or older at the time of starting Olaparib administration.
2) Patients diagnosed with HER2-negative advanced (inoperable) or recurrent breast cancer.
3) Patients with a BRCA1/2 mutation-positive BRCA genetic test (excluding VUS) and who have received, are receiving, or will start Olaparib under the insurance plan since the July 2018 approval of the additional indication for breast cancer
4) Patients who have received less than 2 regimens of chemotherapy for advanced (inoperable) or recurrent breast cancer (not including Olaparib treatment)
Key exclusion criteria
Patients for whom written consent could not be obtained in the prospective observational study. Patients in the retrospective observational study who offered refusal by opt-out.
Target sample size
155
Research contact person
Name of lead principal investigator
| 1st name | 1)Hidetoshi 2)Yasuaki 3) Mitsuchika 4)Shigehira |
| Middle name | |
| Last name | 1)Kawaguchi 2)Sagara 3) Hosoda 4)Saji |
Organization
1) Nagoya City University Hospital
2) Social medical corporation Hakuaikai, Sagara Hospital
3) Hokkaido University Hospital
4) Fukushima Medical University
Division name
1) Department of Breast Surgery 2) Department of Breast Surgery 3) Department of Breast Surgery 4) Department of Medical Oncology
Zip code
467-8602
Address
1, Kawasumi Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL
052-851-5511
hi.kawaguchi@outlook.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Fukase |
Organization
Japan Breast Cancer Research Group (JBCRG)
Division name
Head office
Zip code
103-0016
Address
9-4-3F, Nihonbashi koamicho, Chuo-ku, Tokyo 103-0016, Japan
TEL
03-6264-8873
Homepage URL
https://www.jbcrg.jp/
kikaku@jbcrg.jp
Sponsor or person
Institute
Japan Breast Cancer Research Group
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Cancer Center Institutional Review Board
Address
1-1,Kanokoden,Chikusa-ku,Nagoya, Aichi
Tel
052-762-6111
irb@aichi-cc.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
日本赤十字社松山赤十字病院（愛媛県）、社会医療法人博愛会 相良病院（鹿児島県）、北海道大学病院（北海道）、砂川市立病院（北海道）、広島市立広島市民病院（広島県）、国立研究開発法人国立国際医療研究センター病院（東京都）、横浜市立大学附属市民総合医療センター（神奈川県）、熊本大学病院（熊本県）、国立病院機構名古屋医療センター（愛知県）、埼玉医科大学国際医療センター（埼玉県）、静岡県立総合病院（静岡県）、名古屋市立大学病院（愛知県）、兵庫県立尼崎総合医療センター（兵庫県）、独立行政法人国立病院機構九州がんセンター（福岡県）、八尾市立病院（大阪府）、筑波大学附属病院（茨城県）、昭和大学病院（東京都）、三重大学医学部附属病院（三重県）、兵庫県立がんセンター（兵庫県）、新潟県立中央病院（新潟県）、北里大学病院（神奈川県）、医療法人英仁会大阪ブレストクリニック（大阪府）、市立貝塚病院（大阪府）、市立四日市病院（三重県）、北海道がんセンター（北海道）、東海大学医学部付属病院（神奈川県）、九州大学病院（福岡県）、青森県立中央病院（青森県）、京都大学医学部附属病院（京都府）、国立病院機構大阪医療センター（大阪府）、神戸市立西神戸医療センター（兵庫県）、独立行政法人地域医療機能推進機構久留米総合病院（福岡県）、東京共済病院（東京都）、群馬大学医学部附属病院（群馬県）、社会福祉法人 聖隷福祉事業団 総合病院 聖隷浜松病院（静岡県）、地方独立行政法人 大阪府立病院機構 大阪国際がんセンター（大阪府）、りんくう総合医療センター（大阪府）、岡山大学病院（岡山県）、長野市民病院（長野県）、社会医療法人 神鋼記念会 神鋼記念病院（兵庫県）、神奈川県立がんセンター（神奈川県）、秋田赤十字病院（秋田県）、公益財団法人がん研究会有明病院（東京都）、大阪大学医学部附属病院（大阪府）、大谷しょういちろう乳腺クリニック（広島県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
165
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Since 2014, OlympiAD, a global phase III trial, has been conducted in metastatic breast cancer patients with BRCA mutation-positive and HER2-negative tumors, and proved its efficacy and safety. Following the results of the OlympiAD study, BRCA genetic testing and Olaparib became covered by insurance in July 2018 in Japan. However, there are few reports on the outcomes of Olaparib in actual clinical practice. In addition, only 24 Japanese patients are participating in the OlympiAD study, and only 15 of them have received Olaparib. We designed this study with the primary endpoint of assessing the external validity of the OlympiAD results in Japanese patients.
Management information
Registered date
| 2023 | Year | 03 | Month | 15 | Day |
Last modified on
| 2025 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057633
