Phase 2 trial of eribulin/S-1 combination therapy for advanced/recurrent breast cancer
- Conditions
- Advanced and recurrent breast cancer
- Registration Number
- JPRN-UMIN000015049
- Lead Sponsor
- Advanced Clinical Research Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 32
Not provided
1.patients with history of prior treatment with eribulin and S1 2.patients with infection or HBs antigen positive 3.pleural effusion, peritoneal effusion which needs drainage 4.brain metastasis with clinical symptoms 5.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 6.patients with active double cancer 7.patients who need to receive continuous corticosteroid administration 8.patients with a history of widespread radiation therapy 9.pregnant or nursing women 10.patients with serious drug allergy 11.patients who are participating in the other clinical trial 12.patients judged improper to entry this trial by physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate
- Secondary Outcome Measures
Name Time Method Safety, Duration of response, Progression free survival, Disease control rate, Clinical benefit rate, Overall survival, New metastasis-free survival