An observational study in Breast Cancer, sponsored by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan. Completed at 2 sites in Japan. Open to female participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-06-11.
Sponsored by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan · Observational
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 201 is close to the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan is the lead sponsor of 55 studies on the registry; 2 are open to participants now.
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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.
Exclusion Criteria:
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.
Drug: Eribulin
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.
Overall survival (OS) of the first line chemotherapy
Time frame: From starting date of the first line chemotherapy until date of death from any cause (up to 5 years)
Overall survival (OS) of the second and third line chemotherapy
Time frame: 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
Time frame: 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)
Post progression survival (PPS) of the first, second and third line chemotherapy
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 5 years
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan