Phase I trial of eribulin/S-1 combination therapy for advanced/recurrent breast cancer pretreated by anthracycline and taxane
- Conditions
- Advanced and recurrent breast cancer
- Registration Number
- JPRN-UMIN000009716
- Lead Sponsor
- Depertment of medical oncology, Kinki University Hospital, Faculty of medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 12
Not provided
(1) with symptoms of infectious disease (2) pleural effusion, peritoneal effusion which needs drainage (3) brain metastasis with the necessity of treatment (4) patients with following serious complication 1) Ischemic heart disease and arrhythmic cardiac disease with poor control. 2) ischemic heart disease within 6 months, 3) liver cirrhosis, 4) watery diarrhea 5) interstitial pneumonia or pulmonary fibrosis by chest radiograph 6) bleeding tendency 7) another serious complication (5) patients who need to receive continuous corticosteroid administration (6) positive for HBs antigen (7) patients who treated by widespread radiation therapy (8) pregnant or nursing women (9) patients who are participating in the other clinical trial (10) patients who judged improper to entry this trial by physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method DLT;Dose Limiting Toxicity MTD;Maximum Tolerated Dose
- Secondary Outcome Measures
Name Time Method Overall response rate, Progression free survival, Adverse Event