JPRN-UMIN000009067
Completed
Phase 1
Phase I trial of Gemcitabine plus nab-Paclitaxel for metastatic breast cancer - Phase I trial of Gemcitabine plus nab-Paclitaxel for metastatic breast cancer
Okayama Univesity Hospital0 sites9 target enrollmentOctober 16, 2012
ConditionsBreast cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Breast cancer
- Sponsor
- Okayama Univesity Hospital
- Enrollment
- 9
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\)Allergy of the Gemcitabine or nab\-Paclitaxel 2\)Contraindication to treatment with Gemcitabine or nab\-Paclitaxel 3\)With sever complications ex.)with incontrollable diabetes,with infection,mental disorder which become problem on clinical practice 4\)During pregnancy or lactation 5\)With extensive liver metastases, or lymphatic vessel\-related metastases to lung with dyspnea 6\)With active double cancer 7\)With symptomatic brain cancer 8\)HBs antigen is positive 9\)With uncontrollable hypertension, angina, congestive heart failure, myocardial infection within 1 year, arrhythmia, valvular heart disease 10\)With pulmonary fibrosis or pneumonitis 11\)With dyspnea at rest 12\)With uncontrolled pleural effusion, peritoneal effusion, pericardial effusion 13\)With grade 2 or grater peripheral neuropathy 14\)Patients judged by the investigator as unfit to be enrolled in the study
Outcomes
Primary Outcomes
Not specified
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