Progressive Recurring Breast Cancer
Conditions
Interventions
Combined therapy of Eribulin and Capecitabine
Sponsors
JBCRG (Japan Breast Cancer Research Group)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Female patients who were histologically diagnosed with infiltrating breast cancer. 2) Patients with distal metastasis, unresectable local/regional recurrence, and local advanced breast cancer. 3) Patients with ECOG performance status (PS) of 0 to 1. 4) Patients with history of prior treatment with anthracycline and taxane as pre/post-operative treatment or treatment to prevent recurrence. 5) Patients without history of prior treatment with eribulin. 6) Patients in whom hematological toxicity and non-hematological toxicity regarding DLT are all G1 or lower. 7) Patients without impaired main organ function. The values of laboratory findings within 14 days prior to registration meet all the criteria listed below. (1) neutrophil count: >=2,000/mm3 (2) platelet count: >=100,000 mm3 (3) hemoglobin: >=9.0 g/dL (4) total bilirubin: =<2.0 mg/dL (5)AST (GOT), ALT (GPT), ALP: =<3 times the upper limit of center standard (6) serum creatinine =<1.5 mg/dL 8) Patients with life expectancy of 6 months or longer from the start of the administration. 9) Patients submitted written informed consent to participate in this clinical study. 10) Patients at least 20 years of age but not older than 70 at the time of informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients who were administered with capecitabine in the treatment immediately prior to this clinical study. 2) Patients with coexisting infection or cases with pyrexia suspected of infection. 3) Patients with serious drug allergy. 4) Patients with serious renal disorder and hepatic disorder (jaundice). 5) Patients with clear indications of interstitial pneumonia or pulmonary fibrosis in chest X-ray. 6) Patients with large pleural/peritoneal effusion (patients required drainage) 7) Patients with poorly-controlled hypertension and diabetes mellitus. 8) Patients with continuous systemic administration (oral or intravenous) of steroid. 9) Pregnant patients or cases with possible pregnancy. 10) Patients with active multiple primary cancer. 11) Cases with preexisting condition of psychiatric disorder or central nervous system disorder. 12) Patients with active brain metastasis. 13) Patients participating in other clinical study. 14) Cases that the investigator (subinvestigator) judged as inappropriate as the subject of this clinical study. 15) Patients with hepatitis B antibody.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD, DLT, RD | — |
Secondary
| Measure | Time frame |
|---|---|
| AE, ORR, PK | — |
Countries
Japan
Contacts
Public ContactJun Fukase
JBCRG (Japan Breast Cancer Research Group) Head Office
Outcome results
None listed