Hydralazine as Demethylating Agent in Breast Cancer
Breast Cancer
About this trial
This is an interventional health services research trial for Breast Cancer focused on measuring breast cancer
Eligibility Criteria
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:
- Operable "invasive" breast cancer
- Signed informed consent
- Baseline blood pressure OFF antihypertensives > 110/60 mmHg
Exclusion Criteria:
- Pre-existing hypotension
- Pre-existing liver disease (liver function tests > 2x upper limits of normal ULM).
- Pre-existing kidney (serum creatinine > 2 mg/dl).
- Medical necessity to remain on beta-blockers that cannot be met by other agents.
Sites / Locations
Arms of the Study
Arm 1
Experimental
Hydralazine
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