Phase
Condition
Breast Cancer
Cancer
Treatment
N/AClinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Breast adenocarcinoma treated by neoadjuvant or adjuvant chemotherapy within 12 monthsprior to study enrollment
WHO performance status 0-1
Age ≥18 years old
Affiliation to a social security regime or beneficiary of equivalent social protection
Written informed consent provided before any study specific procedures Complementary inclusion criterion for randomization
Proved vitamin D deficiency as defined by serum vitamin D level lower than 30 ng/ml (75nmol/L).
Exclusion
Exclusion Criteria:
Metastatic disease
History or presence of any other malignancy (except curatively treated nonmelanomaskin cancer or in situ cervix carcinoma) …………. traités dans les 5 ans précédents.
Contraindication to calcium or cholecalciferol
Known severe hypersensitivity to vitamin D or to calcium supplementation or to one ofthe excipients.
Disease and/or medical conditions accompanied by hypercalcaemia and/or hypercalciuria
Calcium lithiasis and tissue calcification
Hypervitaminosis D
Presence of significant comorbidities: i) Uncontrolled endocrine disease ii) Known disorders of calcium phophorus laboratorytesting iii) Proved osteopenia or osteoporosis requiring vitamin D and calciumsupplements
Concomitant treatment with other experimental products or another vitamin D calciumtreatment
Pregnancy, breastfeeding or of reproductive potential not using an effectivecontraceptive method
Legal inability or restricted legal ability. Medical or psychological conditions notallowing proper study completion or informed consent signature
Study Design
Connect with a study center
CRLC Val d'Aurelle-Paul Lamarque
Montpellier, 34298
FranceSite Not Available
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