An Exploratory phase II Study of Eribrin rechallenge after short term therapy of 5-FU for HER2 negative, advanced/recurrent breast cancer.
- Conditions
- HER2 negative, Advanced and recurrent breast cancer
- Registration Number
- JPRN-UMIN000019377
- Lead Sponsor
- Osaka Breast Cancer Chemo-Endocrine Therapy Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 33
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival in Eribrin rechallenging phase
- Secondary Outcome Measures
Name Time Method 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