Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Women, 20 years of age
Stage 3 or 4 breast cancer

Unresectable breast cancer with Expression of Her2 and one of the following criteria including

Prior use of Her2-targeted therapies(Herceptin, Tykerb, taxane and capecitabine) but it was not responding, with Immunohistochemistry (IHC) 3+, or IHC 2+ and FISH+, or SISH+
Patients received treatment that three times continuously Different chemotherapies but it was not responding, with Immunohistochemistry (IHC) 2+ and FISH- or SISH-, or Immunohistochemistry (IHC) 1+
Prior use of six chemotherapies(Anthracycline, Taxane, Gemcitabine, Capecitabine, Vinorelbine, Cyclophosphamide) but it was not responding, with Immunohistochemistry (IHC) 2+ and FISH or SISH-, or Immunohistochemistry (IHC) 1+

One or more measurable(or assessable) lesion of breast or metastatic site

Spiral CT: ≥ 10mm diameter
general measurement methods (CT, X-ray, MRI): ≥ 20mm diameter
Life expectancy 6 months
Signed informed consent

Exclusion Criteria:

Prior use of breast cancer vaccine
Active or history of cardiovascular diseases within the past 3 months: Active uncontrolled cardiac disease, including cardiomyopathy, CHF(NYHA Class III~IV), and unstable angina, family history of congenital long QT syndrome or QT/QTc interval >0.45 sec or torsade de points(TdP), and history of idiopathic ventricular tachycardia or ventricular fibrillation, LVEF < 50%
Patients with coronary artery disease (myocardial infarction, angina, etc.) or a history of coronary artery disease
Patients who is required hospitalization by severe fever or required antibiotic treatment by serious infection
Patients who is confirmed as CNS metastases. (Only, patient with stable brain metastases is permit. Among the patients who have not any symptom, do not see the progression before registered the last 2 month)
History of prior malignancies other than breast cancer within the past 5 years
Patients with an existing condition or a history of autoimmune disease or immunodeficiency disease
ECOG score ≥ 3

Patients with severe dysfunction in major organs

Blood: WBC < 3,000/㎕; Platelet < 100,000/㎕; Hematocrit < 30
Liver: Total bilirubin ≥ 1.5 x ULN; ALT/AST ≥ 2.5 x ULN
Kidney: Creatinine ≥ 1.5 x ULN
Abnormal values of anti-nuclear Ab, anti-double-stranded DNA and C3, as judged by the investigator
History of surgical procedure, chemotherapy, Herceptin treatment, corticosteroid therapy, immunosuppressant therapy or radiotherapy within the past 4 weeks
HIV Ag/Ab, HBs Ag, HCV Ab or HTLV-1 Ab positive
Psychotropic drug misuse/abuse or alcoholism
Prior use of vaccine within the past 4 weeks
Cumulative dose of prior doxorubicin > 360 ㎎/㎡ or epirubicin > 720 ㎎/㎡
Women who is pregnant or breastfeeding and don't agree to use a contraceptive during the study period.
Patients who have participated in clinical trials enrolled in this clinical trial within 4 weeks before. (Only patient, who has taken survey and DNA test without drug-treatment, has permit.)
Patients who are ineligible to participate in this study, as judged by the investigator.
Patients who prohibit administering GM-CSF and prior use of GM-CSF within the past 4 weeks.
Patients who expect hypersensitivity to investigational product (VM206RY) or any component of product.
Due to malignancy neoplasm, patients who require supplementary oxygen or has severe dyspnea at rest
Patients with hypertension [inadequately controlled hypertension (systolic > 180 mm Hg or diastolic > 100 mm Hg)] or a history of hypertension