Phase
Condition
Carcinoma
Precancerous Condition
Cancer
Treatment
Vitamin D3
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients must have histologically confirmed invasive breast carcinoma (IBC) or highgrade (DIN3) Ductal Carcinoma in-situ (DCIS) and be scheduled for primary surgery.
Patients must be recommended/scheduled for primary surgery.
Female patients 18 years of age or older.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
Patients must have normal organ function as defined below:
Aspartate aminotransferase (AST/SGOT) < 4 times institutional upper limit ofnormal.
Alanine transaminase (ALT/SGPT) < 4 times institutional upper limit of normal.
Serum Bilirubin < 1.5 mg/dl.
Serum Alkaline Phosphatase < 4 times institutional upper limit.
Creatinine within normal institutional limits OR; Creatinine clearance >/= 60mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.
Albumin within normal institutional limits
Women of childbearing potential (WoCBP) must have a negative (serum or urine)pregnancy test and agree to use barrier contraception while on treatment and for 30-days thereafter.
Ability to understand and the willingness to sign a written informed consentdocument by patient or their legal representatives.
Exclusion
Exclusion Criteria:
Previous history of breast cancer diagnosis or treatment.
Synchronous bilateral breast cancer.
Metastatic breast cancer
Patients recommended for neoadjuvant systemic therapy.
Patients may not be receiving any other investigational agents or have participatedin any investigational drug study within 4 weeks preceding the start of studytreatment.
Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliancewith the study requirements.
Concurrent other malignancy
Uncontrolled hypertension
Chronic cholestatic or alcoholic liver disease
Chronic pancreatitis
Kidney impairment or renal stones
History of parathyroidectomy
Hypercalcemia, defined as serum level >11 mg/dl.
Abnormal laboratory data for: AST (SGOT), ALT (SGPT), Serum Bilirubin, Alkalinephosphatase, Creatinine and/or Creatinine clearance, and Albumin.
Patients receiving medications that are incompatible with VD.
Prior or known allergic reaction(s) to Vitamin D or other forms of Vitamin D.
Female patients who are pregnant or breast feeding.
Study Design
Study Description
Connect with a study center
University of Miami
Miami, Florida 33136
United StatesSite Not Available

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