metastatic breast cancer
Conditions
Interventions
Eribulin 1.4 mg/m2 IV day1 and day8, q3w repeated until PD or for at least 6 cycles
S1 S-1: orally bid, days, 1-14, q3w Dose according to BSA <
1.25 m2, 80 mg/day 1.25 to 1.5 m2, 100 mg/day more than 1.5 m2, 120 mg/day repeated until PD or for at least 6 cycles
Sponsors
CSPOR-BC
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Key inclusion criteria 1) Histologically proven breast cancer 2) One of the following conditions has to be met for a diagnosis of metastatic breast cancer. a) At presentation, the patients have distant metastasis. b) The patient has breast cancer that has worsened or recurred in association with distant metastasis after treatment (after surgery and pre- and post-operative treatment); however, local recurrence is excluded. 3) Patients need to receive chemotherapy for metastatic breast cancer 4) Performance status (ECOG scale): 0-1 5) The presence of at least one measurable lesion. However, sites treated by radiotherapy are not considered assessable lesions. 6) Adequate major organ functions within 14 days before enrollment., as defined below: Neutrophil count > 1,500/mm3 Platelet count > 100,000/mm3 Hemoglobin > 9.0 g/dL AST < 100 U/L ALT < 100 U/L Total bilirubin < 2.1 mg/dL Serum creatinine < 1.6 mg/dL and Ccr > 50mL/min 7)A given time has passed from the last treatment. 14 days : irradiation, endocrine therapy and chemotherapy 28 days : surgery 8) Age of 20-75 years. 9) Patients will protect the procedure of the clinical trial. 10) Duration of survival is expected more than six months 11) Written informed consent.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HRQoL : health related quality of life | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Progression free survival, time to treatment failure, new metastatic free survival, safety, economic evaluation, patient preference | — |
Countries
Japan
Contacts
Public ContactCSPOR-BC CSPOR-BC
CSPOR-BC secretariat
Outcome results
None listed