Clinical trial with the NGcGM3/VSSP/Montanide ISA 51 vaccine to treat patients with breast cancer IIa, IIb and IIIa surgically treated with positive ganglia and disease-free, Phase IIb/III.

Center of Molecular Immunology (CIM)0 个研究点目标入组 744 人开始时间: 2010年12月17日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment

•1.Female patients with breast cancer IIa, IIb y IIIa surgically treated with positive ganglia and clinical disease-free following onco-specific treatment. 2.Patients who underwent first-line onco-specific therapy (surgery, chemotherapy, hormonal therapy and radiotherapy) according to treatment guides established in the country, and those who completed the different protocols in a time period between 4 and 8 weeks before inclusion. 3.Informed consent of the patient to participate in the research. 4.Performance Status according to WHO from 0 to 2. 5.Age >= 18 years. 6.Reproductive-age patients with confirmed negative pregnancy tests using adequate contraceptive methods (intrauterine devices, hormonal contraceptives, barrier methods, or tubal ligation). 7.Determination of hormonal receptor (estrogens and progesterones), HER-1, HER-2/neu and 14F7 primary tumor expressions. This determination must be made using the surgical piece biopsy for diagnosis. 8.Patients with axillary dissection will only be eligible if 10 or more ganglia were ablated and examined.

•1.Patients who underwent onco-specific therapy and completed the different protocols within 4 weeks or more than 8 weeks before trial inclusion. 2.Patients with history of demyelinating or inflammatory disease of the peripheral or central nervous system. 3.Pregnancy or breastfeeding. 4.Patients with acute or chronic infectious diseases. 5.Patients with acute allergic conditions or history of severe allergic reactions. 6.Patients with psychiatric diseases, unable to understand and sign the informed consent document. 7.Patients with autoimmune diseases or decompensated chronic diseases.

发起方

Center of Molecular Immunology (CIM)