Hydralazine and Valproate Added to Chemotherapy for Breast Cancer

Phase 2 Terminated 43 enrolled National Institute of Cancerology National Council of Science and Technology, Mexico · collab Psicofarma, S.A. De C.V. · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

Aberrant DNA methylation and histone deacetylation participate in cancer development and progression, as epigenetic alterations are common to breast cancer, in this phase II study, the demethylating hydralazine plus the HDAC inhibitor magnesium valproate will be added to neoadjuvant doxorubicin and cyclophosphamide in locally advanced breast cancer to assess their safety and biological efficacy.

Timeline

Start: 2005-06
Primary completion: —
Completion: 2006-08

Publications

Arce C, Perez-Plasencia C, Gonzalez-Fierro A, de la Cruz-Hernandez E, Revilla-Vazquez A, Chavez-Blanco A, Trejo-Becerril C, Perez-Cardenas E, Taja-Chayeb L, Bargallo E, Villarreal P, Ramirez T, Vela T, Candelaria M, Camargo MF, Robles E, Duenas-Gonzalez A. A proof-of-principle study of epigenetic therapy added to neoadjuvant doxorubicin cyclophosphamide for locally advanced breast cancer. PLoS One. 2006 Dec 20;1(1):e98. doi: 10.1371/journal.pone.0000098.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Hydralazine	Small molecule	83 mg	—
Subject	Hydralazine	Small molecule	182 mg	—
Subject	Valproic Acid	Small molecule	30 mg/kg	—

Hydralazine and Valproate Added to Chemotherapy for Breast Cancer

Summary

Timeline

Publications

Drugs

Indications