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

Study Overview
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Brief Summary
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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
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2 Arms Randomization in patients with metastatic breast cancer. Arm A = Docetaxel + High dose Vitamin D2 Arm B = Docetaxel + Standard dose Vitamin D2

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Docetaxel + High dose Vitamin D2
* Drug: Docetaxel + Standard dose Vitamin D2


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Arm A = Docetaxel + High dose Vitamin D2 | Drug: Docetaxel + High dose Vitamin D2<br>* Docetaxel + High dose Vitamin D2<br>|
| Active Comparator: Arm B<br>Docetaxel + Standard dose Vitamin D2 | Drug: Docetaxel + Standard dose Vitamin D2<br>* Docetaxel + Standard dose Vitamin D2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D in patients with metastatic breast cancer