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
2 Arms Randomization in patients with metastatic breast cancer.
Arm A = Docetaxel + High dose Vitamin D2
Arm B = Docetaxel + Standard dose Vitamin D2
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Time to progression is from the start of Docetaxel to disease progression. Patients who have not progressed at the time of study completion or who are lost to follow-up are censored at the last Vitamin D administration date.
1 year
Yes
Taher Al-Tweigeri, MD
Principal Investigator
KFSHRC
United States: Institutional Review Board
RAC # 2091-009
NCT00944424
July 2009
July 2012
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