Multicenter pahse II tiral of combination therapy using abraxane and trastuzumab +-pertuzumab for HER2-positive locally advanced or metastatic breast cancer
- Conditions
- ocally advanced or metastatic breast cancer
- Registration Number
- JPRN-UMIN000006838
- Lead Sponsor
- Department of Breast and Endocrine Surgery, Hyogo College of Medicine
- Brief Summary
Retrospective-prospective study was conducted with eribulin or nab-paclitzxel + trastuzumab + pertuzumab. Progression-free survival was significantly improved in patients with baseline absolute lymphocyte count more than 1500 (p=0.0106).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 21
Not provided
1) With history of hypersensitivity reaction for paclitaxel, trastuzumab, and pertuzumab. 2) With serious drug allergy 3) Pregnant or nursing women 4) With active another cancer 5) With widespread liver metastases or pulmonary lymphangitis with dyspnea 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) Poorly controlled diabetes 9) With pulmonary fibrosis or pneumonitis 10) With dyspnea at rest (due to metastatic lung lesion and cardiovascular disease) 11) With pleural effusion, ascites, and pericardial effusion that need treat 12) Infection or possible infection associated with clinical symptoms such as fever 13) Patients have active hepatitis type B 14) Cases who physician judged improper to entry this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method response rate
- Secondary Outcome Measures
Name Time Method safety, progression-free survival, overall survival