Effect of High Dose Vitamin D on Cancer Biomarkers and Breast Cancer Tumors

Last updated: April 15, 2026
Sponsor: Eli Avisar, MD
Overall Status: Trial Not Available

Phase

1/2

Condition

Carcinoma

Precancerous Condition

Cancer

Treatment

Vitamin D3

Clinical Study ID

NCT02856503
20150288
  • Ages > 18
  • Female

Study Summary

High-doses of Vitamin D (VD) may be used as targeted therapy against breast cancer. The investigators will assess the effect of high dose VD on the following biomarkers in the breast cancer cells: VDR, estrogen receptor (ER), progesterone receptor (PR), epidermal growth factor receptor 2 (Her2/neu), androgen receptor (AR), as well as epidermal growth factor receptor 1 (EGFR) and Ki-67, as markers of proliferation, and E-cadherin, a marker of invasion and metastasis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients must have histologically confirmed invasive breast carcinoma (IBC) or highgrade (DIN3) Ductal Carcinoma in-situ (DCIS) and be scheduled for primary surgery.

  2. Patients must be recommended/scheduled for primary surgery.

  3. Female patients 18 years of age or older.

  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

  5. 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

  1. 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.

  2. Ability to understand and the willingness to sign a written informed consentdocument by patient or their legal representatives.

Exclusion

Exclusion Criteria:

  1. Previous history of breast cancer diagnosis or treatment.

  2. Synchronous bilateral breast cancer.

  3. Metastatic breast cancer

  4. Patients recommended for neoadjuvant systemic therapy.

  5. Patients may not be receiving any other investigational agents or have participatedin any investigational drug study within 4 weeks preceding the start of studytreatment.

  6. 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.

  7. Concurrent other malignancy

  8. Uncontrolled hypertension

  9. Chronic cholestatic or alcoholic liver disease

  10. Chronic pancreatitis

  11. Kidney impairment or renal stones

  12. History of parathyroidectomy

  13. Hypercalcemia, defined as serum level >11 mg/dl.

  14. Abnormal laboratory data for: AST (SGOT), ALT (SGPT), Serum Bilirubin, Alkalinephosphatase, Creatinine and/or Creatinine clearance, and Albumin.

  15. Patients receiving medications that are incompatible with VD.

  16. Prior or known allergic reaction(s) to Vitamin D or other forms of Vitamin D.

  17. Female patients who are pregnant or breast feeding.

Study Design

Treatment Group(s): 1
Primary Treatment: Vitamin D3
Phase: 1/2
Study Start date:
January 13, 2019
Estimated Completion Date:
April 15, 2024

Study Description

This is a phase I/II open-label, non-randomized study. In phase I, a fixed weekly course of oral high-dose Vitamin D (VD) is planned for either 3, 4 or 5 weeks; patients will be sequentially enrolled into 3 groups (A, B or C respectively) in a manner such that no more than two patients may have treatment-limiting toxicities (TLTs).

After the group with the optimal duration of VD therapy to achieve a "favorable response" is determined, phase II will begin enrollment.

Patients must be scheduled to have surgery performed within 2- weeks of the last dose of VD.

Connect with a study center

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

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