Patients with recurrent HER2-negative breast cancer with a history of neoadjuvant or adjuvant therapy with anthracyclines and taxanes with no or one prior metastatic breast cancer chemotherapy regimens. Prior hormonal therapy for metastatic breast cancer is permitted.
Conditions
Interventions
Eriburin
Paclitaxel, Docetaxel, nab- Paclitaxel, Vinorelbine (An inhibitor of microtubule dynamics was used in the TPC group)
Sponsors
JBCRG(Japan Breast Cancer Research Group)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Female patients with a histological diagnosis of invasive breast cancer. 2) Recurrent HER2-negative breast cancer 3) ECOG performance status(PS)0 - 1. 4) Patients with measurable lesions by RECIST. 5) Patients with a history of neoadjuvant or adjuvant therapy with anthracyclines and taxanes. Patients at least 6 months after neoadjuvant or adjuvant therapy in case of taxanes. 6) Patients in whom Eribulin has not been used in the pretreatment. 7) Patients with no or one prior metastatic breast cancer chemotherapy regimens. 8) Patients in whom the major organ functions have been maintained. The criteria listed below are all met within 14 days before enrollment. (1) Neutrophil count: At least 1,500/mm3 (2) Platelet count: At least 100,000 mm3 (3) Hemoglobin: At least 9.0 g/dL (4) Total bilirubin: Not exceeding 2.0 mg/dL (5) AST (GOT) and ALT (GPT): Under 100 IU/L(Under 150 IU/L for patients who has hepatic metastasis) (6) Serum creatinine: Not exceeding 1.5 mg/dL 9) Patients with no clinical problems on electrocardiography. 10) Patients from whom written consent for participation in the study has been obtained in person.
Exclusion criteria
Exclusion criteria: 1) Patients with infectious complications, or with a fever and suspected infection. 2) Patients with a severe drug allergy. 3) Patients with severe renal impairment or hepatic dysfunction (jaundice). 4) Patients with clear interstitial pneumonia or pulmonary fibrosis on chest X-ray. 5) Patients with a large amount of pleural effusion or ascites (patients who need drainage) 6) Patients with poorly controlled hypertension or diabetes. 7) Patients who have undergone continuous and systemic administration of steroids (oral or intravenous). 8) Pregnant patients or patients who may be pregnant. 9) Active multiple primary cancers. 10) Patients with a history of a psychiatric disorder that causes a clinical problem, or a central nervous system disorder. 11) Patients with active brain metastasis. 12) Patients who are receiving another treatment at the time. 13) Patients who are judged to be unsuitable as a subject of the treatment by the investigator (subinvestigator) (including those with significant disease progression or cases that are likely to develop a life-threatening condition if a response is not immediately obtained).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS (progression free survival) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)TTF(time to treatment failure) 2)Response rate and response duration 3)Frequency of incidence of adverse events 4)Treatment continuation at 6 months after the start of treatment 5)Time and duration of the incidence of adverse events leading to reduction in QOL (peripheral neuropathy, edema, and skin manifestations) Exploratory endpoints: 1)Type (drug name), PFS and response rate of secondary and tertiary treatment 2)OS (overall survival) | — |
Countries
Japan
Contacts
Public ContactJun Fukase
JBCRG(Japan Breast Cancer Research Group) Head Office
Outcome results
None listed