Stopped: Study termination due to negative Ph III of another study product from same technology platform.
The purpose of this study is to evaluate the safety, immunogenicity and clinical activity of a new WT1 anti-cancer immunotherapy in patients with WT1-positive Stage II or III breast cancer. The treatment will be given before surgery in combination with standard therapy.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Number of Subjects With Severe Toxicities
Timeframe: From Week 0 to Week 26/32 (period starting from GSK2302024A/placebo treatment allocation and ending with the concluding Visit i.e.: Week 26 for patients receiving 6 injections and Week 32 for patients receiving 8 injections)
Number of Patients With an Anti-Wilm's Tumor Gene (Anti-WT1) Humoral Response
Timeframe: At post-GSK2302024A/placebo Dose 4 (Week 13)
Number of Patients With Adverse Events (AEs)
Timeframe: During the treatment period and up to 30 days post last administration
Number of Subjects With Serious Adverse Events SAE(s)
Timeframe: From Week 0 to Week 26/32 (period starting from GSK2302024A/placebo treatment allocation and ending with the concluding Visit i.e.: Week 26 for patients receiving 6 injections and Week 32 for patients receiving 8 injections)
Number of Subjects With Alanine Aminotransferase Increased Abnormality, by Common Terminology Criteria for Adverse Events (CTCAE) Maximum Grade
Timeframe: During the treatment period and up to 30 days post last administration
Number of Subjects With Alkaline Phosphatase Increased Abnormality, by CTCAE Maximum Grade
Timeframe: During the treatment period and up to 30 days post last administration
Number of Subjects With Anemia, by CTCAE Maximum Grade
Timeframe: During the treatment period and up to 30 days post last administration
Number of Subjects With Aspartate Aminotransferase Increased Abnormality, by CTCAE Maximum Grade
Timeframe: During the treatment period and up to 30 days post last administration
Number of Subjects With Blood Bilirubin Increased Abnormality, by CTCAE Maximum Grade
Timeframe: During the treatment period and up to 30 days post last administration
Number of Subjects With Creatine Increased Abnormality, by CTCAE Maximum Grade
Timeframe: During the treatment period and up to 30 days post last administration
Number of Subjects With Hemoglobin Increased Abnormality, by CTCAE Maximum Grade
Timeframe: During the treatment period and up to 30 days post last administration
Number of Subjects With Hypercalcemia Abnormality, by CTCAE Maximum Grade
Timeframe: During the treatment period and up to 30 days post last administration
Number of Subjects With Hyperkalemia Abnormality, by CTCAE Maximum Grade
Timeframe: During the treatment period and up to 30 days post last administration
Number of Subjects With Hypernatremia Abnormality, by CTCAE Maximum Grade
Timeframe: During the treatment period and up to 30 days post last administration
Number of Subjects With Hypoalbuminemia Abnormality, by CTCAE Maximum Grade
Timeframe: During the treatment period and up to 30 days post last administration
Number of Subjects With Hypocalcemia Abnormality, by CTCAE Maximum Grade
Timeframe: During the treatment period and up to 30 days post last administration
Number of Subjects With Hypokalemia Abnormality, by CTCAE Maximum Grade
Timeframe: During the treatment period and up to 30 days post last administration
Number of Subjects With Hyponatremia Abnormality, by CTCAE Maximum Grade
Timeframe: During the treatment period and post 30 days post last administration
Number of Subjects With Lymphocyte Count Decreased Abnormality, by CTCAE Maximum Grade
Timeframe: During the treatment period and up to 30 days post last administration
Number of Subjects With Lymphocyte Count Increased Abnormality, by CTCAE Maximum Grade
Timeframe: During the treatment period and up to 30 days post last administration
Number of Subjects With Neutrophil Count Decreased Abnormality, by CTCAE Maximum Grade
Timeframe: During the treatment period and up to 30 days post last administration
Number of Subjects With Platelet Count Decreased Abnormality, by CTCAE Maximum Grade
Timeframe: During the treatment period and up to 30 days post last administration
Number of Subjects With White Blood Cell Decreased Abnormality, by CTCAE Maximum Grade
Timeframe: During the treatment period and up to 30 days post last administration
Number of Patients With Adverse Events (AEs), by CTCAE Maximum Grade Reported
Timeframe: During the treatment period and up to 30 days post last administration
Number of Subjects With Adverse Events (AEs) Assessed by the Investigators as Causally Related to GSK2302024A Treatment, by CTCAE Maximum Grade Reported
Timeframe: During the treatment period and up to 30 days post last administration
Number of Subjects With Serious Adverse Events (SAEs), by CTCAE Maximum Grade Reported
Timeframe: During the treatment period and up to 30 days post last administration
Number of Subjects With Serious Adverse Events (SAEs), Assessed by the Investigators as Causally Related to GSK2302024A Treatment, by CTCAE Maximum Grade Reported
Timeframe: During the treatment period and up to 30 days post last administration
Number of Subjects With Breast Cancer Pathological Response
Timeframe: During the treatment period, up to Week 26/32