A Phase II Study of Neo-adjuvant Combination Therapy of Trastuzumab and Anastrozole for Hormone Receptor-Positive, HER2-Positive Postmenopausal Breast Cancer(WJOG7412B)
- 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
Not provided
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
Name Time Method Pathological complete response rate
- Secondary Outcome Measures
Name Time Method Safety, Response rate, Disease free survival, Overall survival, Breast conserving rate