Prospective observational Study to explore the efficacy of Eribulin as 1st-line or 2nd-line chemotherapy in patients with HER2-negative hormone-resistant inoperable or recurrent metastatic breast cancer
Not Applicable
- Conditions
- HER2-negative hormone-resistant inoperable or recurrent metastatic breast cancer
- Registration Number
- JPRN-UMIN000018178
- Lead Sponsor
- Kyoto Breast Cancer Research Network (KBCRN)
- Brief Summary
Among 201 patients enrolled, 180 were included in the final analysis. Eribulin was administered as first- and second-line chemotherapy to 46 (26.6%) and 70 (47.9%) patients, respectively. Median OS1 and OS2 were 2.25 (95% CI 1.07-2.68) and 1.75 (95% CI, 1.28-2.45) years for first- and second-line eribulin, respectively. Oral 5-FU followed by eribulin had a numerically longer OS1 (2.84 years) than the other sequences.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 180
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients with symptomatic metastasis in the central nervous system. 2) Patients with a previous history of hypersensitivity to any component of drugs administered in the treatment. 3) Patients considered inappropriate for the study participation judged by the primary physician.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival (OS) of the first line chemotherapy from starting date of the first line chemotherapy until death from any cause
- Secondary Outcome Measures
Name Time Method 1) Overall survival (OS) of the second and third line chemotherapy from starting date of each chemotherapy until death from any cause 2) Progression-free survival (PFS) of the first, second and third line chemotherapy 3) Post progression survival (PPS) of the first, second and third line chemotherapy 4) Time to treatment failure (TTF) of the first, second and third line chemotherapy 5) New metastasis-free survival (nMFS) of the first, second and third line chemotherapy 6) QALY (Japanese version of the EQ-5D-5L) 7) Serious adverse events