Breast Cancer
Conditions
Keywords
Vitamin D in patients with metastatic breast cancer
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
Interventions
DRUGDocetaxel + High dose Vitamin D2
Docetaxel + High dose Vitamin D2
DRUGDocetaxel + Standard dose Vitamin D2
Docetaxel + Standard dose Vitamin D2
Sponsors
King Faisal Specialist Hospital & Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Kuwait, Saudi Arabia, United Arab Emirates
Contacts
Primary ContactTaher Tweigeri, MD
Backup ContactRomelia Retuta
Outcome results
None listed