Safety and Immunogenicity Study of the New dHER2 Vaccine to Treat HER2-positive Metastatic Breast Cancer
- Conditions
- -C509 Breast, unspecifiedBreast, unspecifiedC509
- Registration Number
- PER-009-06
- Lead Sponsor
- GLAXOSMITHKLINE BIOLOGICALS,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
1. The patient is female.
2. The patient is at least 18 years of age.
3. The patient gives written informed consent to participate in the study.
4. The patient has a diagnosis of advanced breast cancer.
5. A tumor lesion of the patient, who underwent a biopsy before, or during, the selection, which presents: a) overexpression of HER2 protein, determined by IHC (result: IHC 3+), or b) Amplification of the HER2 gene determined by FISH (at least quadruple, that is, at least 8 copies).
6. Only for patients considered for the first line of treatment of the study: The metastatic disease of the patient affects the skin, lymph nodes or lungs, but not another organ.
7. The patient has at least one measurable injury.
8. The patient has an ECOG status of 0 to 1.
9. The patient agrees to use effective contraception during the study, and states that she does not plan to have children in the future.
10. The result of a pregnancy test of B-HCG in serum is negative.
11. The patient has an adequate reserve of bone marrow indicated by: WBC> 3000 / mm3, neutrophils> 1500 / mm3, platelets> 100,000 mm3, lymphocytes> 1000 / mm3, and hemoglobin> 10.0 g / dL.
12. The patient has adequate renal function, demonstrated by the creatinine value.
13. The patient has adequate liver function.
14. The patient has a baseline LVEF, as measured by MUGA angiography, equal to or greater than the lower normal limit.
15. The results of viral selection tests (HCV, and HBV surface antigen) are negative.
16. The researcher considers that the patient can and wants to comply with the requirements of the protocol.
1. Only for patients considered for the first line of treatment of the study: The patient has received some chemotherapy for their metastatic breast disease.
2. The patient received> 300 mg / m2 of doxorubicin or> 600 mg / m2 epirubicin.
3. Although hormonal therapy will be accepted as the first line of therapy for metastatic disease, it must NOT have been initiated or modified within 12 weeks prior to the first vaccination of the study, and NO such change will be anticipated during the study.
4. The patient is receiving bisphosphonate treatment, UNLESS the bisphosphonate treatment has been initiated more than three months before the first study vaccination.
5. The patient received any investigational or unregistered drug or vaccine other than the study vaccine within 30 days prior to the first dose of study vaccine, or planned to receive this drug during the study.
6. For the patients considered for the first line of treatment of the study: any of the following will cause the exclusion of the patient: a) The metastatic disease affected any organ besides the skin, lymph nodes, bones and lungs. b) If the lungs are affected: More than three lung lesions were detected. c) If the lungs are affected: Some injury is more than 30 mm or more. d) If the lungs are affected: The pulmonary metastasis causes any functional limitation. e) During the study, the sponsor may indicate to the centers not to include more patients with pulmonary metastasis.
7. The patient has a history of cardiac arrest or congestive heart failure or difficult to control hypertension, hypercholesterolemia or diabetes.
8. The patient has known coronary artery disease, arrhythmia requiring treatment, clinically significant valvular disease, cardiomegaly on radiographs, ventricular hypertrophy or previous myocardial infarction.
9. The patient has any functional pulmonary, cardiovascular, hepatic or renal abnormality, acute or chronic and clinically significant.
10. The patient has autoimmune disease.
11. The patient requires chronic administration (defined as more than 14 days) of immunosuppressive drugs, including corticosteroids.
12. The patient´s medical history includes splenectomy or irradiation of the spleen.
13. There is a family history of congenital or hereditary immunodeficiency.
14. The patient received organ grafting.
15. The patient has any uncontrolled bleeding or coagulation disorder, or thrombocytopenic or prothrombotic disorder.
16. The patient has a history of anaphylaxis or severe allergic reaction to vaccines or unknown allergens.
17. The patient is HIV positive.
18. The patient has (or had) previous or concomitant malignancies in other sites.
20. The patient is pregnant or breast-feeding.
21. The patient has any psychiatric or addictive disorder that could compromise her ability to give informed consent, or to comply with the study procedures.
22. The patient has any history of drug or alcohol abuse.
23. Presence of any other condition that, in the opinion of the investigator, could endanger the safety of the patient or her ability to meet the requirements of the study.
24. The patient received any commercial vaccine in the seven days prior to the first study vaccination.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method