HERA (HERceptin Adjuvant) Trial
- Conditions
- Breast CancerCancer - Breast
- Registration Number
- ACTRN12607000011482
- Lead Sponsor
- F.Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 4482
Eastern Cooperative Oncology Group (ECOG) performance status = 1; Non-metastatic operable primary invasive adenocarcinoma of the breast that is: histologically confirmed, adequately excised, axillary node positive or negative, and tumour size =T1c according to TNM; Known hormone receptor status (ER/PgR or ER alone); Patient must have received at least four cycles of an approved (neo-) adjuvant chemotherapy regimen; Baseline LVEF = 55% measured by echocardiography or MUGA scan after completion of all (neo-) adjuvant chemotherapy and radiotherapy); Completion of radiotherapy for any patients undergoing radiotherapy; Overexpression of HER2 in the invasive component of the primary tumour, according to one of the following definitions: 3+ overexpression by IHC or 2+ overexpression by IHC AND fluorescence in situ hybridisation (FISH) test demonstrating c-erbB2 gene amplification, or c-erbB2 gene amplification by FISH; Completion of all necessary baseline lab and radiologic investigations; Signed written informed consent
History of any prior (ipsi- and/or contralateral) invasive breast carcinoma; Past or current history of malignant neoplasms, except for curative treated: basal and squamous cell carcinoma of the skin, in situ carcinoma of the cervix; Any clinical” T4 tumour, including inflammatory breast cancer; Maximum cumulative dose of doxorubicin >360mg/m2 or maximum cumulative dose epirubicin > 720mg/m2 or any prior anthracyclines unrelated to the present breast cancer; (Neo-) or adjuvant chemotherapy using peripheral stem cell or bone marrow stem cell support; Any prior mediastinal irradiation except internal mammary node irradiation for the present breast cancer; Patients with positive or suspicious internal mammary nodes identified by sentinel node technique which have not been irradiated or patients with supraclavicular lymph node involvement; Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for breast cancer; Concurrent anti-cancer treatment in another investigational trial, including hormone therapy, immunotherapy, and bisphosphonate therapy; Serious cardiac illness or medical conditions including but not confined to: History of documented congestive heart failure (CHF), high-risk uncontrolled arrythmias, angina pectoris requiring antianginal medication, clinically significant valvular heart disease, evidence of transmural infarction on ECG, poorly controlled hypertension; Other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions/illness; Any of the following abnormal laboratory tests immediately prior to randomisation: serum bilirubin > 2.0 x upper limit of normal (ULN), alanine amino transferase (ALAT) or aspartate amino transferase (ASAT) > 2.5 x ULN, alkaline phosphatase (ALP) > 2.5 x ULN, serum creatinine > 2.0 x ULN, total white blood cell count (WBC) < 2500/mm3, absolute neutrophil count < 1500/mm3, platelets <100,000/mm3; Pregnant or lactating women; Women of childbearing potential or less than one year after menopause (unless surgically sterile) who are unable or unwilling to use adequate contraceptive measures during study treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method