MedTrace Logo

Hydralazine and Valproate Added to Chemotherapy for Breast Cancer

NCT00395655 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2006-11-03

No results posted yet for this study

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.

Conditions

  • Locally Advanced Breast Cancer

Interventions

DRUG

Hydralazine and magnesium valproate administration

PROCEDURE

Core-needle biopsy of the breast

Sponsors & Collaborators

  • National Council of Science and Technology, Mexico

    collaborator OTHER

  • Psicofarma S.A. de C.V.

    collaborator OTHER

  • National Institute of Cancerología

    lead OTHER_GOV

Principal Investigators

  • Claudia Arce, MD · Division of Clinical Research, IInstituto Nacional de Cancerologia, Mexico

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Completion
2006-08-31

Countries

  • Mexico

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00395655 on ClinicalTrials.gov