NCT00944424

Phase III Trial of High Dose vs. Standard Dose Vit D2 With Docetaxel in Met Breast ca

GORG - 002 Randomized Phase III Trial to Determine the Effectiveness of High Dose Versus Standard Dose of Vitamin D2 (Ergocalciferol) Given With Docetaxel in Patients With Metastatic Breast Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: King Faisal Specialist Hospital & Research Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Randomized phase III trial to determine the effectiveness of High dose versus Standard dose of Vitamin D2 (Ergocalciferol) given with Docetaxel in patients with metastatic breast cancer

Detailed description

2 Arms Randomization in patients with metastatic breast cancer. Arm A = Docetaxel + High dose Vitamin D2 Arm B = Docetaxel + Standard dose Vitamin D2

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel + High dose Vitamin D2	Docetaxel + High dose Vitamin D2
DRUG	Docetaxel + Standard dose Vitamin D2	Docetaxel + Standard dose Vitamin D2

Timeline

• Start date: 2009-07-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2009-07-23
• Last updated: 2011-12-13

Locations

6 sites across 3 countries: Kuwait, Saudi Arabia, United Arab Emirates