Hormone receptor-positive, HER2-positive postmenopausal breast cancer
Conditions
Interventions
Neoadjuvant Combination therapy of Trastuzumab and Anastrozole
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Pathologically confirmed resectable breast cancer Stage I-IIIB (T1-4 and N0-1) 2)Resectable at the day of enrollment 3)Hormone receptor-positive and HER2-positive (3+ staining by IHC or HER2 gene amplification [HER2:CEP17 signal ratio of 2.0 or more] by FISH) confirmed by pathology. 4)ECOG performance status 0-1 5)Postmenopausal (amenorrhea for at least one year/menopause due to bilateral ovariectomy) 6)Previously untreated with trastuzumab or aromatase inhibitors 7)No previous surgery or radiation therapy for ipsilateral breast 8)Adequate baseline organ and marrow function as defined below: Absolute neutrophil count >= 1.5x10^9/L Hemoglobin >= 9.0g/dL AST and ALT <= 100IU/L Serum bilirubin <= 1.5mg/dL Serum creatinine <= 1.5mg/dL 9)Baseline left ventricular ejection fraction (LVEF) >= 50% by echocardiography 10)Signed written informed consent
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, Response rate, Disease free survival, Overall survival, Breast conserving rate | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacente
Outcome results
None listed