JPRN-UMIN000035869
Not yet recruiting
未知
Phase I and II trial of combination therapy using nab-Paclitaxel+Pertuzumab+Trastuzumab for HER2 positive metastatic breast cancer - Combination therapy of nab-Paclitaxel+Pertuzumab+Trastuzumab
The University of Tokushima Graduate School, Depertment of Thoracic, Endocrine surgery and Oncology, Institute of Health Bioscience0 sites30 target enrollmentApril 1, 2019
Conditionsmetastatic breast cancer
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- metastatic breast cancer
- Sponsor
- The University of Tokushima Graduate School, Depertment of Thoracic, Endocrine surgery and Oncology, Institute of Health Bioscience
- Enrollment
- 30
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\.Without previous chemotherapy 2\.With brain metastasis with symptom 3\.With active another cancer 4\.With uncontrollable hypertension, angina pectoris, congestive heart failure, myocardial infection within 6 months, arrhythmia that need treat, valvular heart disease 5\.With dyspnea at rest due to metastatic lung lesion 6\.Insufficient organ function meeting following criteria Neutrophil \<1500/mm2 Platelet \<100000/mm2 Hemoglobin \<8\.0g/dL AST(GOT)\>100IU/L (with liver function disorder by metastasis) ALT (GPT) \>100IU/L (with liver function disorder by metastasis) Serum total bilirubin \<2\.0mg/dL Serum creatinine \>2\.0mg/dL or 177umol/L 7\.With uncontrollable systemic disease (cardiovascular/pulmonary/metabolic, protracted wound healing, ulcer and bone fracture) 8\.With uncontrollable hypercalcemia even by Bisphosphonate or denosumab 9\.Pregnant or nursing women 10\.Infection or possible infection associated with clinical symptoms 11\.With history of hypersensitivity reaction for paclitaxel, trastuzumab, and pertuzumab. 12\.Cases who physician judged improper to entry this trial
Outcomes
Primary Outcomes
Not specified
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