NCT01606072

Perioperative Use of Desmopressin (DDAVP) in Breast Cancer

Perioperative Administration of Desmopressin to Subjects With Breast Cancer: A Phase IIa, Dose-Escalation Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Laboratorio Elea Phoenix S.A. · Industry
• Sex: Female
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The propose for this study is to evaluate the safety and tolerability of desmopressin when administered perioperatively to patients with breast cancer undergoing surgery as first treatment, and select the optimum dose for the clinical development of the product.

Detailed description

Breast cancer is one of the most commonly diagnosed malignancies among women, and its mortality is related to the capacity of tumor cells to invade and produce metastases. It is postulated that tumor manipulation during surgery results in the release of tumor cells into circulation or the lymphatic system, and that these released cells survive due to aggregation among them or with platelets through the formation of a fibrin layer on the embolus. Tumor cells surviving transportation through circulation will join blood vessels and invade vascular walls, forming metastases. The interruption of this process might reduce survival of tumor cells and thus the formation of metastases from breast cancer cells in the lungs or other tissues.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Desmopressin	20 patients in 5 groups 4 each, advancing progressively to each dose level.

Timeline

• Start date: 2011-11-01
• Primary completion: 2015-02-01
• Completion: 2015-07-01
• First posted: 2012-05-25
• Last updated: 2015-08-28

Locations

1 site across 1 country: Argentina