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

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).