Phase I and II trial of combination therapy using nab-Paclitaxel+Pertuzumab+Trastuzumab for HER2 positive metastatic breast cancer
- Conditions
- metastatic breast cancer
- Registration Number
- JPRN-UMIN000035869
- Lead Sponsor
- The University of Tokushima Graduate School, Depertment of Thoracic, Endocrine surgery and Oncology, Institute of Health Bioscience
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 30
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method time to treatment failure
- Secondary Outcome Measures
Name Time Method safety(after the first cycle) response rate (best effect)