Phase II trial of Trastuzumab in combination with Abraxane for patients with HER2-positive metastatic breast cancer
- Conditions
- HER2-positive Metastatic breast cancer
- Registration Number
- JPRN-UMIN000006159
- Lead Sponsor
- Kumamoto Breast Cancer Cooperative Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 23
Not provided
(1)With history of hypersensitivity reaction for trastuzumab, paclitaxel and albumin (2)With severe complication. (3)Pregnant or nursing women. (4)With widespread liver metastases or pulmonary lymphangitis with dyspnea (5) with active another cancer (6)with brain metastasis with symptom (7)with uncontrollable hypertension, angina pectoris, congestive heart failure, myocardial infection within 1 year, arrhythmia that need treat, valvular heart disease. (8)with pulmonary fibrosis or pneumonitis. (9)with dyspnea at rest (due to metastatic lung lesion and cardiovascular disease). (10)with pleural effusion, ascites, and pericardial effusion that need treat (11) Cases who physician judged improper to entry this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival
- Secondary Outcome Measures
Name Time Method Response rate Safety