Clinical trial · Interventional
Hydralazine as Demethylating Agent in Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): IRB request
Summary
Brief summary (as posted)
This study will be conducted as a phase I/II clinical trial. In addition to determining the maximum tolerated dose (MTD) of hydralazine, the phase I trial will be performed to identify unexpected toxicities that may occur when hydralazine is used in conjunction with neoadjuvant chemotherapy in normotensive women with breast cancer. Once the phase I trial is successfully completed, the phase II trial to evaluate the efficacy of hydralazine in producing a demethylation effect will begin.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hydralazine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hydralazine
- description
- The objective of this study is to determine the MTD for hydrazaline added to standard neoadjuvant chemotherapy for operable breast cancer. Four dose levels of hydrazalline are planned: Dose Level 1: 150 mg/d 50 mg PO TID Dose Level 2: 200 mg/d 50 mg PO QID Dose Level 3: 225 mg/d 75 mg PO TID
- interventionNames
- Drug: Hydralazine
Primary outcomes (1)
- measure
- To explore the potency of a clinical tolerable dose of hydralazine as a demethylating agent as indicated.
Secondary outcomes (1)
- measure
- 1. Reversal of promoter methylation of eight Tumor Suppressor Genes (TSGs) reported as candidates for epigenetic silencing in breast cancer using Methylation-Specific
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients referred to the breast cancer service for diagnostic evaluation for "breast growth" will be candidates to participate in this study. Patients with history of elevated blood pressure and who are already on anti-hypertensives would be ideal candidates for this project. In such situation, hydralazine will replace other anti-hypertensives. There is no age limit for this study. Inclusion criteria are as follows: 1. Operable "invasive" breast cancer 2. Signed informed consent 3. Baseline blood pressure OFF antihypertensives \> 110/60 mmHg Exclusion Criteria: 1. Pre-existing hypotension 2. Pre-existing liver disease (liver function tests \> 2x upper limits of normal ULM). 3. Pre-existing kidney (serum creatinine \> 2 mg/dl). 4. Medical necessity to remain on beta-blockers that cannot be met by other agents.
References
Publications (0)
Data not yet available