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A Phase II Study of Neo-adjuvant Combination Therapy of Trastuzumab and Anastrozole for Hormone Receptor-Positive, HER2-Positive Postmenopausal Breast Cancer(WJOG7412B)

Phase 2
Conditions
Hormone receptor-positive, HER2-positive postmenopausal breast cancer
Registration Number
JPRN-UMIN000011023
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
70
Inclusion Criteria

Not provided

Exclusion Criteria

1)Active infection under treatment 2)Concurrent serious disease or condition 3)Pulmonary fibrosis or interstitial pneumonitis by chest X-ray 4)Abnormal electrocardiography findings with clinical symptoms 5)Patients with other active malignancies 6)Concurrent serious psychiatric disorder 7)Concurrent massive body cavity fluid (pleural effusion, ascites or cardiac effusion, etc)needs treatment 8)Concurrent continuous systemic treatment with steroids 9)History of serious allergic reactions 10)HBsAg or HCVAb-positive 11)Patient considered irrelevant by the attending physician for the study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Pathological complete response rate
Secondary Outcome Measures
NameTimeMethod
Safety, Response rate, Disease free survival, Overall survival, Breast conserving rate
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