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

Phase 3

• Conditions: Breast Cancer
• Interventions: Drug: Docetaxel + High dose Vitamin D2; Drug: Docetaxel + Standard dose Vitamin D2

• Registration Number: NCT00944424
• Lead Sponsor: King Faisal Specialist Hospital & Research Center

Brief 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

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-22
• Study First Submitted QC: 2009-07-22
• Study First Posted: 2009-07-23
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-11
• Last Update Posted: 2011-12-13
• Primary Completion: 2012-07
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 260

Inclusion Criteria

• Histologically proven metastatic adenocarcinoma of the breast.
• Gender: female.
• Age ≥18 years.
• ECOG performance status ≤ 2.(see appendix I)
• 25 (OH) Vitamin D level ≤ 100nmol/L (40ng/L).
• No more than 1 prior chemotherapy regimen not including Docetaxel or Paclitaxel for metastatic breast cancer.
• Patients progressed on Doxorubicin or epirubicin as first line for metastatic breast cancer is eligible.
• Concurrent bisphosphonate therapy allowed.
• Life expectancy more than 6 months
• At least 12 months since prior adjuvant or neo-adjuvant chemotherapy including Taxanes regimens.
• Adequate hematologic, hepatic and renal function.
• Written informed consent.

Exclusion Criteria

• Pregnant or lactating women.

• Male breast cancer.

• Women of childbearing potential unless surgically sterile or using adequate measures of contraception.

• Metastatic inflammatory breast cancer.

• CNS metastasis.

• Leptomeningeal carcinomatosis.

• Malignant hypercalcemia.

• History of kidney stones.

• History of active primary hyperparathyroidism.

• Normal 25 (OH) Vitamin D level ≥100 nmol/L or ≥ 40 ng/L.

• Previous or concomitant malignancy of any type, except adequately treated basal cell carcinoma of the skin or in situ cervix cancer.

• Patient on any anti-Psychotic medications or Steroid therapy.

• History of malabsorption syndrome (pancreatic insufficiency, celiac disease and tropical sprue).

• Any of the following abnormal baseline hematological values:

  • ANC < 1.0 x109/L, or platelets < 100.000 x 109/L.

• Any of the following abnormal laboratory tests: total serum bilirubin >2.00 x ULN (upper limit of normal), AST, ALT > 2.5 x ULN or ALP >2.50 x ULN (upper limit of normal).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Docetaxel + High dose Vitamin D2	Arm A = Docetaxel + High dose Vitamin D2
Arm B	Docetaxel + Standard dose Vitamin D2	Docetaxel + Standard dose Vitamin D2

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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.	1 year

Trial Locations

Locations (6)

King Abdulaziz Hospital and Oncology Center; 🇸🇦 Jeddah, Saudi Arabia

King Fahad Medical City; 🇸🇦 Riyadh, Saudi Arabia

Kuwait Cancer Center; 🇰🇼 Kuwait City, Kuwait

King Abdulaziz Medical City; 🇸🇦 Riyadh, Saudi Arabia

King Faisal Specialist Hospital & Research Center; 🇸🇦 Riyadh, Central, Saudi Arabia

Tawam Hospital; 🇦🇪 Al Ain City, United Arab Emirates