Prospective, Randomized, Single-Blinded, Multi-Center Phase II Trial of the HER2/neu Peptide GP2 + GM-CSF Vaccine versus GM-CSF Alone in HLA-A2+ OR the Modified HER2/neu Peptide AE37 + GM-CSF Vaccine versus GM-CSF Alone in HLA-A2- Node-Positive and High-Risk Node-Negative Breast Cancer Patients to Prevent Recurrence - BR-HER-GP2-AE37

Generex Biotechnology Corporation0 个研究点目标入组 600 人开始时间: 2007年6月5日最近更新: 2018年7月23日

适应症

试验速览

暂无简介。

•1.NP or high-risk NN breast cancer patients. The latter is defined as any one of the following: T2, grade 3, lymphovascular invasion, ER/PR negative, or N0 (i+).
•2.HER2/neu-expressing tumor (IHC 1-3+ and/or positive FISH >1.2)
•3.Completion of primary standard of care breast cancer therapies (i.e., surgery, chemotherapy, immunotherapy and radiation therapy as appropriate per standard of care for patients’ specific cancer)
•4.Clinically cancer-free (no evidence of disease)
•5.Patients may be enrolled between 1-6 months from completion of standard primary breast cancer therapies.
•6.Immunologically intact by recall anergy testing
•7.Good performance status
•8.Capable of informed consent
•Are the trial subjects under 18?
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1.HER2/neu- breast cancers (IHC 0)
•2.Clinical and/or radiographic evidence of residual or persistent breast cancer
•3.Anergic by the Mantoux panel of recall antigens
•4.Receiving immunosuppressive therapy to include chemotherapy, steroids, or methotrexate
•5.In poor health (Karnofsky <60%, ECOG >2)
•6.Tbili >1.8, creatinine>2, hemoglobin<10, platelets<50,000, WBC<2,000
•7.Active pulmonary disease requiring medication to include multiple inhalers
•8.Pregnancy (urine HCG)
•9.Breast feeding
•10.History of autoimmune disease
•11.Involved in other experimental protocols

发起方