Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00395655
Status:
TERMINATED
Last Update Posted:
2006-11-03
First Post:
2006-11-01
Brief Title:
Hydralazine and Valproate Added to Chemotherapy for Breast Cancer
Sponsor:
National Institute of Cancerología
Organization:
National Institute of Cancerología
Study Overview
Official Title:
A Phase II Clinical Study of Hydralazine and Valproic Acid in Combination With Neoadjuvant Cytotoxic Chemotherapy in Stage IIB and IIIA Breast Carcinoma
Status:
TERMINATED
Status Verified Date:
2006-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Eligible patients after signing the informed consent and will undergo study evaluation and then typed for acetylator phenotype before being treated with hydralazine at 182 mg for rapid- or 83 mg for slow-acetylators and magnesium valproate at 30 mgkg starting from day -7 until chemotherapy ends Chemotherapy will consists in a regimen of four cycles of doxorubicin 60 mgm2 and cyclophosphamide 600 mgm2 every 21 days followed by surgery to assess the pathological response Adjuvant radiation and additional treatment will be done in off-protocol basis according to standard institutional policies Blood samples and core-needle biopsies will be taken from primary breast tumors at diagnosis and at day 8 of treatment with hydralazine and valproate Global cytosine content global DNA methylation and histone deacetylase activity will be assessed in peripheral blood DNA The transcriptional profile in the primary breast tumor before and after treatment will also be analyzed as well as the plasma levels of hydralazine and valproic acid
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None