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| ID | Type | Description | Link |
|---|---|---|---|
| UMIN000018178 | Registry Identifier | UMIN-CTR |
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| Name | Class |
|---|---|
| Kyoto Breast Cancer Research Network | OTHER |
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This is a observational study in a real-world setting, not requiring determining a dosage regimen, dose reduction criteria, rest period criteria and withdrawal criteria. The purpose of the study is to investigate the efficacy of eribulin as the first or second line chemotherapy to prolong overall survival and to explore factors affecting the survival in patients with HER2-negative hormone-resistant inoperable or recurrent metastatic breast cancer who scheduled to receive the first or second line chemotherapy in clinical practice in Japan. The total duration of the study will be a maximum of 5 years, consisting of 2-year enrollment period and 3-year observational period; the duration of patient participation will be 3 years. All patients will receive adequate treatment for breast cancer which selected by the primary physician after enrollment using the Japanese Breast Cancer Society Clinical Practice Guideline of Breast Cancer and the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Investigators at the investigational sites will enter patient data into an electronic data capture (EDC) system up to the third chemotherapy in the study. The end of the study is defined as the time the last patient completes observational period. Patients will primarily be assessed by overall survival (OS) of the first line chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational group | All patients will receive adequate treatment for breast cancer which selected by the primary physician after enrollment using the Japanese Breast Cancer Society Clinical Practice Guideline of Breast Cancer and the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Investigators at the investigational sites will enter patient data into an electronic data capture (EDC) system up to the third chemotherapy in the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eribulin | Drug | Eribulin 1.4 mg/m2 will be administered intravenously over 2 to 5 minutes on day 1 and 8 of every 21-day cycle, in a real-world setting. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) of the first line chemotherapy | From starting date of the first line chemotherapy until date of death from any cause (up to 5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) of the second and third line chemotherapy | From starting date of each line of chemotherapy until date of death from any cause (up to 5 years) | |
| Progression-free survival (PFS) of the first, second and third line chemotherapy | From starting date of each line of chemotherapy until the date of first documented disease progression or date of death from any cause, whichever comes first (up to 5 years) |
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Inclusion Criteria:
Exclusion Criteria:
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Female patients with HER2-negative hormone-resistant inoperable or recurrent metastatic breast cancer, who are scheduled to receive the first or second line chemotherapy in clinical practice in Japan.
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| Name | Affiliation | Role |
|---|---|---|
| Yuichiro Kikawa, MD | Kobe City Medical Center General Hospital | Principal Investigator |
| Takeshi Kotake, MD | Kyoto University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kobe City Medical Center General Hospital | Kobe | Hyōgo | 650-0047 | Japan | ||
| Kyoto University Hospital |
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| Post progression survival (PPS) of the first, second and third line chemotherapy | From the date of first documented disease progression in each line of chemotherapy until date of death from any cause (up to 5 years) |
| Time to treatment failure (TTF) of the first, second and third line chemotherapy | From starting date of each line of chemotherapy until date of discontinuation of study treatment for any reason including disease progression, treatment toxicity or death (up to 5 years) |
| New metastasis-free survival (nMFS) of the first, second and third line chemotherapy | From starting date of each line of chemotherapy until the date of first documented disease progression due to appearance of a new metastasis or date of death from any cause, whichever comes first (up to 5 years) |
| Assessment and comparison of Quality Adjusted Life Years (QALYs) in the first, second and third line chemotherapy, using Japanese version of the EQ-5D-5L value set | From date of the baseline QALYs assessment in each line of chemotherapy until the last date of each line of chemotherapy (up to 5 years) |
| Serious adverse events | Up to 5 years |
| Kyoto |
| Kyoto |
| 606-8507 |
| Japan |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C490954 | eribulin |
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