Perioperative Use of Desmopressin (DDAVP) in Breast Cancer

Inclusion Criteria

• •a. Female subjects from 21 to 60 years of age, who have voluntarily signed the informed consent form.
• •b. Histological/cytological diagnosis of breast carcinoma obtained at least 21 days before inclusion into the study.
• •c. Candidate for radical mastectomy and requiring resection of axillary lymph nodes or sentinel node.
• •d. In case of women of childbearing potential, an adequate birth control method (intrauterine device, barrier methods, or tubal ligation) should be used throughout the study. Post-menopausal women should have menopause confirmed by biochemical parameters.
• •e. Adequate organic function, defined by the following parameters:
• •* Electrocardiogram (ECG) with no significant anomalies, performed within 14 days prior to surgery.
• •* The following laboratory results, obtained 7 days before surgery:
• •* Hemoglobin ≥ 11 g/dL
• •* Total white blood cell count ≥ 4,000/mm3
• •* Total neutrophil count 1,500/mm3
• •* Platelet count within normal limits
• •* Total bilirubin ≤1.5 x UNL or 2.5 x UNL in case of hepatic metastasis
• •* Transaminases ALT/GPT and AST/GOT ≤ 1.5 x UNL
• •* Creatinine clearance \>50 mg/dL
• •* CT scan with oral and endovenous contrast\* of chest, pelvis, and abdomen, and bone scan, conducted within 28 days prior to surgery. Images taken not longer than 90 days before surgery are also acceptable.
• •* In case contrast is contraindicated, CT with no contrast or MRI will be performed.
• •f. Subject with performance status (ECOG) = 0.
• •e. Patients with a history or presence of congestive heart failure, blood hypertension, angina pectoris or heart arrhythmia, thromboembolic disease, diabetes type I or II, or any underlying coronaropathy detected in pre-surgical evaluations.
• •f. Mentally-impaired patients. g. Patients with known hypersensitivity to DDAVP or vasopressin, o with severe von Willebrand's disease (VWD), defined by a VWF activity \<10%IU/dL, or type 2B VWD, defined by an increased ristocetin-induced platelet aggregation (RIPA) at low concentrations of ristocetin or with hemophilia.
• •h. Patients with a history of seizures. i. Patients with renal impairment (creatinine clearance \< 50 mL/min calculated by the Cockcroft-Gault formula), hyponatremia or with a history of hyponatremia.
• •j. Patients with syndrome of inadequate secretion of antidiuretic hormone. k. Patients with positive serology for the hepatitis B or C virus and/or HIV. l. Patients with known hepatic disease (diagnosed cirrhosis, hepatic enzymes (GOT/GPT) \> 1.5 x UNL, Total bilirubin \> 1.5 x UNL).
• •m. Patients with active infections. n. Patients with other malignant diseases, with the exception of, non-melanoma skin cancer, or cervix cancer in situ, or any other tumor that has received adequate treatment and shows a disease-free time ≥ 5 years.
• •o. Patients participating in another clinical study or cases in which less than 4 weeks have elapsed since participation in another clinical study.