Safety and Immunogenicity Study of the New dHER2 Vaccine to Treat HER2-positive Metastatic Breast Cancer

Exclusion Criteria

• •For patients being considered for first-line study treatment only:
• •Received any chemotherapy for metastatic breast disease.
• •Received \>300 mg/m2 doxorubicin (cumulative dose) or \>600 mg/m2 epirubicin (cumulative dose).
• •Although hormone therapy as a first-line therapy for metastatic disease is accepted, it must NOT have been started or modified (in nature or dosage) within the 12 weeks before the first study vaccination, and NO such change during the study period may be anticipated.
• •Treatment with bisphosphonate UNLESS the bisphosphonate treatment was initiated more than 3 months before first study vaccination.
• •Received any investigational or non-registered drug or vaccine other than the study vaccine within the 30 days preceding the first dose of study vaccine, or plans to receive such a drug during the study period.
• •For patients being considered for first-line study treatment, any of the following will result in exclusion of the patient:
• •1. Any organ other than skin, lymph nodes, bone and lung is affected by the metastatic disease.
• •2. If the lung is affected: \>3 lung lesions have been detected.
• •3. If the lung is affected: Any lesion measures 30 mm or more (longest diameter).
• •4. If the lung is affected: The lung metastases cause any functional impairment.
• •5. The sponsor may during the study instruct sites that no further patients with lung metastases are to be included. Receipt of such instructions from the sponsor constitutes an exclusion criterion for all further patients with lung metastases.For patients being considered for second-line study treatment, the presence of lung metastases that cause any functional impairment following will result in exclusion of the patient.
• •The patient has a history of congestive heart failure or difficult-to-control hypertension, hypercholesterolemia or diabetes.
• •The patient has known coronary artery disease, arrhythmia requiring treatment, clinically significant valvular disease, cardiomegaly on chest X-ray, ventricular hypertrophy (found by ECG) or previous myocardial infarction.
• •The patient has any acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• •The patient presents with autoimmune disease.
• •The patient requires chronic administration of immunosuppressive drugs including corticosteroids.
• •Medical history includes splenectomy or irradiation to the spleen.
• •Known family history of congenital or hereditary immunodeficiency.
• •Received major organ graft (including bone-marrow transplantation).
• •Any uncontrolled bleeding disorder or coagulation disorder or thrombocytopenia or prothrombotic disorder.
• •History of anaphylaxis or severe allergic reaction to vaccines or unknown allergens.
• •HIV positive.
• •Previous or concomitant malignancies at other sites, except (i) effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix, and (ii) effectively treated malignancy that has been in remission for \>2 years and which is considered highly likely to have been cured.
• •Pregnant or lactating.
• •Any psychiatric or addictive disorder that may compromise ability to give informed consent, or to comply with the trial procedures.
• •Any history of alcohol or drug abuse.
• •Any other condition is present that in the opinion of the investigator might jeopardize the patient's safety or ability to comply with requirements of the study
• •Received any commercial vaccine within one week before the first study vaccination.