Breast Cancer Clinical Trial
Official title:
Lynparza Tablets 100mg, 150mg CEI, Investigation on Development of Bone Marrow Depression in Patients With Unresectable or Recurrent BRCA Mutated HER2 Negative Breast Cancer Who Have Previously Received Anticancer Chemotherapy
| NCT number | NCT03590938 |
| Other study ID # | D0819C00005 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | August 14, 2018 |
| Est. completion date | March 24, 2022 |
| Verified date | March 2023 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
To characterise the development of ADRs of bone marrow depression in patients under actual post-marketing use
| Status | Completed |
| Enrollment | 111 |
| Est. completion date | March 24, 2022 |
| Est. primary completion date | March 24, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - Unresectable or recurrent BRCA mutated HER2 negative breast cancer with prior anticancer chemotherapy Exclusion Criteria: - The patients who are not started on Lymparza for the first time |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Research Site | Aichi | |
| Japan | Research Site | Aomori | |
| Japan | Research Site | Chiba | |
| Japan | Research Site | Ehime | |
| Japan | Research Site | Fukui | |
| Japan | Research Site | Fukuoka | |
| Japan | Research Site | Gunma | |
| Japan | Research Site | Hiroshima | |
| Japan | Research Site | Hokkaido | |
| Japan | Research Site | Hyogo | |
| Japan | Research Site | Ibaraki | |
| Japan | Research Site | Ishikawa | |
| Japan | Research Site | Kagawa | |
| Japan | Research Site | Kagoshima | |
| Japan | Research Site | Kanagawa | |
| Japan | Research Site | Kochi | |
| Japan | Research Site | Kyoto | |
| Japan | Research Site | Miyagi | |
| Japan | Research Site | Nagano | |
| Japan | Research Site | Nara | |
| Japan | Research Site | Okayama | |
| Japan | Research Site | Okinawa | |
| Japan | Research Site | Osaka | |
| Japan | Research Site | Saitama | |
| Japan | Research Site | Shiga | |
| Japan | Research Site | Shimane | |
| Japan | Research Site | Shizuoka | |
| Japan | Research Site | Tokyo | |
| Japan | Research Site | Toyama | |
| Japan | Research Site | Yamagata | |
| Japan | Research Site | Yamaguchi |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Adverse drug reactions of bone marrow depression | Bone marrow depression will be investigated as safety specification topics | One year period |
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