HER2 negative, Advanced and recurrent breast cancer
Conditions
Interventions
Eribulin will be reintroduced after short term S-1 treatment against the patients who have ceased prior Eribulin as 1st line chemotherapy before disease progression.
Sponsors
Osaka Breast Cancer Chemo-Endocrine Therapy Study Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Pathologically confirmed primary breast cancer 2.Woman equal or more than 20years old 3.Inoperable or recurrent breast cancer (expect for Stage3disease) 4.HER2-negative by IHC or FISH 5.ECOG performance status 0-2 at the registration 6.Without prior cytotoxic chemotherapy for inoperable or recurrent breast cancer 7.Patients with measurable lesion 8.Organ functions satisfies all the conditions below (within a month before registration) neutrophil >=1,500/mm3 Plt >=75,000/mm3 Hb >=8.0g/dL AST and ALT <=100IU/L, (AST and ALT>=300IU/L, if patients have liver metastasis) total bilirubin >=2.0mg/dL creatinine clearance >=60 ml/min 9.Informed consent is obtainable from the patient herself in documented form.
Exclusion criteria
Exclusion criteria: 1.Patient with active infection 2.brain metastasis with clinical symptoms 3.Pregnant, lactating, or intends to become pregnant 4.History of hypersensitivity to a protocol treatment drug or a vehicle in the drug preparation. 5.Active multiple primary cancer (heterochronous multiple cancers that are concurrent, where the cancer-free period is also less than 5 years. Carcinoma in situ deemed to be cured by local treatment (lesions that are intraepithelial carcinoma or mucosal cancer) is not included as an active multiple cancer. 6.Extensive liver metastases, or lymphangitic lung metastasis with accompanying dyspnea. 7.Only 1 lesion that is a target of evaluation, with a history of radiotherapy having been performed on the same site. 8.Pleural effusion, ascites, or pericardial effusion that required emergency treatment. 9.Interstitial pneumonia or pulmonary fibrosis 10.Positive for HBs antigen 11.Uncontrolled diabetes mellitus 12.Study participation is difficult due to mental illness or psychiatric symptoms. 13.Patient is deemed unsuitable for study participation by an investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival in Eribrin rechallenging phase | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, Disease control rate of Eribrin rechallenging phase, Time to Failure of Strategy, Overall response rate after 1 cycle of S-1 therapy, Overall survival | — |
Countries
Japan
Contacts
Public ContactTsutomu Takashima
Osaka City University Graduate school of Medicine Department of Surgical oncology
Outcome results
None listed