UMIN-ICDS 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 2024/03/22 11:22:43

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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) Matsuyama Red Cross 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

790-0826

Address

1 Bunkyo-cho, Matsuyama-shi, Ehime 790-8524 Japan

TEL

089-924-1111

Email

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/

Email

office@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

Email

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



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

2024 Year 03 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057633


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name