Vitamin D Supplementation to Correct the Vitamin D Deficiency for Breast Cancer

A PHASE II Multicentric Trial Evaluating a High Dose Vitamin D Supplementation to Correct the Vitamin D Deficiency for Breast Cancer Treated by Adjuvant Chemotherapy

An open clinical trial not randomized, multicentric. This study search to evaluate vitamin D supplementation efficacy at high dose (UVEDOSE, colecalciferol, oral solution at 100 000 UI) of vitamin D on day 1 of each cycles for breast cancer treated adjuvant chemotherapy.

A calcium supplementation will be prescribed in parallel.

An initial dosage of 25OH vitamin D rate will be done and a vitamin-calcic dosage will done on day 1 of every cycles of chemotherapy

Inclusion Criteria:

• Breast adenocarcinoma should receive 6 cycles of adjuvant chemotherapy
• Women ≥ 18 years old (no age limit)
• Performance status :0 or 1
• Patients must be affiliated to a Social Security System
• Signed informed consent obtained before any study specific procedures.
• Vitamin D deficiency confirmed ( vitamin D result must be < at 30 ng/ml)

Exclusion Criteria:

• Metastatic disease
• Patients with previous or concomitant other (not breast cancer) malignancy within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for at least five years
• calcium or colecalciferol contraindications (vitamin D hypersensitivity - disease or an other condition result in hypercalcaemia or hypercalciuria -Calcic lithiasis- high vitamin D level)
• Presence of the following diseases in the last 3 years : endocrinal disease, A phosphor calcic disorder treated by vitamin D supplementation at 1000 UI/day or more (this patient who have received a dose < 1000 UI/day, will be included after have to stop Vitamin D at least 48 hours ) - Osteopenia or osteoporosis confirmed treated
• Concomittant treatment with an other experimental product
• Pregnant or breastfeeding women
• Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study.