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Investigation of correlation between antitumor effect of combined lapatinib/capecitabine therapy and p95HER2, PTEN and PIK3CA in patients with HER2 positive breast cancer

Not Applicable
Completed
Conditions
Breast cancer
Registration Number
JPRN-UMIN000007153
Lead Sponsor
Kyushu Breast Cancer Study Group
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
Female
Target Recruitment
200
Inclusion Criteria

Not provided

Exclusion Criteria

1.Pregnant or lactation women, or women with suspected pregnancy 2.Patients who suffer malabsorption syndrome or disease affecting gastro intestinal function, or resection or stomach or small intestine, or ulcerative colitis 3.Coexistence malignant tumor other than breast cancer or a history of such tumor within 5 years of the beginning of this study 4.Patients who has not recovered from previous cancer treatment to less than G1 toxicity 5.Previous or current history of interstitial pneumonia 6.Active or poorly controlled infectious diseases 7.Severe psychiatric disorder 8.Poorly controlled or symptomatic angina pectoris, arrhythmia or congestive heart failure 9.Symptomatic CNS metastasis 10.Meningitis carcinomatosa 11.History of immediate or delayed hypersensitivity reaction to the compounds similar to both capecitabine and lapatinib 12.Patients judged by the investigator to be unfit for the study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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