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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
260
Docetaxel + High dose Vitamin D2
Docetaxel + Standard dose Vitamin D2
Kuwait Cancer Center
Kuwait City, Kuwait
NOT_YET_RECRUITINGKing Faisal Specialist Hospital & Research Center
Riyadh, Central, Saudi Arabia
RECRUITINGKing Abdulaziz Hospital and Oncology Center
Jeddah, Saudi Arabia
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.
Time frame: 1 year
Overall survival is defined as the time from start of Docetaxel to death due to any cause. Patients for whom no death is captured on the clinical database are censored at the last date they were known to be alive.
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
King Abdulaziz Medical City
Riyadh, Saudi Arabia
NOT_YET_RECRUITINGKing Fahad Medical City
Riyadh, Saudi Arabia
NOT_YET_RECRUITINGTawam Hospital
Al Ain City, United Arab Emirates
NOT_YET_RECRUITING