None listed
Conditions
Brief summary
The best treatment for some women with early breast cancer includes a few months of chemotherapy after their surgery. However, even with the best treatment, the cancer sometimes re-occurs. Trastuzumab, also known as Herceptin, is a new drug that targets breast cancer cellls that have a special receptor (HER2) on them. Trastuzumab is benefical for women with advanced breast cancers that have HER2. This large, international trial will determine if adding Trastuzumab to best standard treatment improves cure rates for women with early breast cancers with HER2. It will also determine whether it is better to continue treatment with Trastuzumab for 1 or 2 years.
Interventions
Patients will be randomised upon completion of definitive surgery and systemic adjuvant chemotherapy to receive no Herceptin® or Herceptin® for one year* or two years**. Patients will receive Herceptin by intravenous infusion at a dose of 8mg/kg on day 1, followed by maintenance dose of 6mg/kg three weeks later and thereafter every three weeks for a total of one or two years, or until disease recurrence.
* “1 year” of Herceptin® is defined as “12 calendar months of treatment from day 1 of 1st a
Patients will be randomised upon completion of definitive surgery and systemic adjuvant chemotherapy to receive no Herceptin® or Herceptin® for one year* or two years**. Patients will receive Herceptin by intravenous infusion at a dose of 8mg/kg on day 1, followed by maintenance dose of 6mg/kg three weeks later and thereafter every three weeks for a total of one or two years, or until disease recurrence. * “1 year” of Herceptin® is defined as “12 calendar months of treatment from day 1 of 1st administration and 18 infusions maximum. ** “2 years” of Herceptin® is defined as “24 calendar months of treatment from day 1 of 1st administration and 35 infusions maximum. If clinically indicated, all ER positive patients can receive systemic adjuvant hormonal therapy. Radiation therapy when indicated must have been completed prior to the start of Herceptin®.
Sponsors
F.Hoffmann-La Roche Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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.
Outcome results
None listed