Efficacy and safety of Olaparib treatment for advanced or recurrent breast cancer (OPTIMAL study)

Olaparib treatment in metastatic/advanced breast cancer patients using real world data in Japan (OPTIMAL study) - JBCRG-C09 (OPTIMAL study)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000050600

Enrollment

155

Registered

2023-03-15

Start date

2023-04-01

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

HER2 negative advanced or recurrence (metastatic) breast cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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)

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Investigator-assessed Progression Free Survival (investigator-assessed PFS) for all Olaparib treatment lines (up to 1st+2nd+3rd lines) and by treatment line.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactJun Fukase

Japan Breast Cancer Research Group (JBCRG) Head office

JBCRG-QAG@jbcrg.jp03-6264-8873

Outcome results