A Phase III, Open Label, Randomized, Controlled, Multicenter Study, comparing Eribulin with S1, to assess Health-related Quality of Life (HRQoL) in the Treatment of Her2 negative Metastatic Breast Cancer Patients
- Conditions
- metastatic breast cancer
- Registration Number
- JPRN-UMIN000021398
- Lead Sponsor
- CSPOR-BC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 330
Not provided
Key exclusion criteria 1) HER2 positive 2) more than two regimens of chemotherapy for metastatic breast cancer 3) Using Eribulin or S1 before enrollment 4) Presence of Grade 3 non hematologic or hematologic toxicities 5) Lung fibrosis, interstitial pneumonitis, 6) severe cardiac dysfunction, ischemic heart disease 7) Severe pleural effusion or ascites 8) The sustained systemic steroid treatment 9) Severe allergic history against medicines 10) Pregnant or the pregnancy is doubted 11) The presence of brain metastasis requiring treatment 12) The presence of other active cancers (synchronous double cancers or metachronous double cancers with a disease-free interval of 5 years or less). 13) Bilateral breast cancer (However, registration is permitted when contralateral breast cancer is DCIS or the status of ER and HER2 is same) 14) Physician concludes that the patient's participation in this trial is inappropriate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HRQoL : health related quality of life
- Secondary Outcome Measures
Name Time Method Overall survival, Progression free survival, time to treatment failure, new metastatic free survival, safety, economic evaluation, patient preference