Evaluation of an Anti-cancer Immunotherapy Combined With Standard Neoadjuvant Treatment in Patients With WT1-positive Primary Invasive Breast Cancer

NCT01220128 ↗

Phase 2 Terminated 66 enrolled GlaxoSmithKline

RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start: 2011-04-11
Primary completion: 2014-11-14
Completion: 2014-11-14

Publications

Higgins M, Curigliano G, Dieras V, Kuemmel S, Kunz G, Fasching PA, Campone M, Bachelot T, Krivorotko P, Chan S, Ferro A, Schwartzberg L, Gillet M, De Sousa Alves PM, Wascotte V, Lehmann FF, Goss P. Safety and immunogenicity of neoadjuvant treatment using WT1-immunotherapeutic in combination with standard therapy in patients with WT1-positive Stage II/III breast cancer: a randomized Phase I study. Breast Cancer Res Treat. 2017 Apr;162(3):479-488. doi: 10.1007/s10549-017-4130-y. Epub 2017 Feb 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GSK2302024A	Protein / enzyme biologic	—	Intramuscular
Background	Carboplatin	Small molecule	—	Intravenous
Background	Cyclophosphamide	Other / unclassified	—	Intravenous
Background	Docetaxel	Small molecule	—	Intravenous
Background	Doxorubicin	Other / unclassified	—	Intravenous
Background	Epirubicin	Small molecule	—	Intravenous
Background	Exemestane	Small molecule	—	Intravenous
Background	Letrozole	Other / unclassified	—	Intravenous
Background	Paclitaxel	Small molecule	—	Intravenous
Background	Trastuzumab	Monoclonal antibody	—	Intravenous
Background	fluorouracil	Small molecule	—	Intravenous

Evaluation of an Anti-cancer Immunotherapy Combined With Standard Neoadjuvant Treatment in Patients With WT1-positive Primary Invasive Breast Cancer

Summary

Timeline

Publications

Drugs

Indications