Randomized phase II trial evaluating trastuzumab + capecitabine (HX) or lapatinib + capecitabine (LX) in HER2-positive metastatic breast cancer patients previously treated with trastuzumab and taxanes
- Conditions
- HER2-positive metastatic breast cancer
- Registration Number
- JPRN-UMIN000005219
- Lead Sponsor
- West Japan Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 110
Not provided
1) History of other malignancy,except for curatively treated carcinoma in situ or intramucosal carcinoma (Subjects with other malignancies who have been disease-free for at least 5 years are eligible.) 2) Active infection under treatment 3) Concurrent serious disease or condition 4) Pulmonary fibrosis or interstitial pneumonitis by chest x-ray 5) Symptomatic brain metastases or carcinomatous meningitis 6) History of serious allergic reactions 7) Concurrent continuous systemic treatment with medications listed below: Steroids Warfarin CYP3A4 inducing anticonvulsants Rifampicin Azole antifungals 8) Concurrent serious psychiatric disorder 9) Pregnant or lactating females or subjects of childbearing potential who do not agree to use adequate contraception 10) HBsAg-positive
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival
- Secondary Outcome Measures
Name Time Method Overall response rate, overall survival, proportion of subjects progressing with brain metastases as site of first progression, and safety