Effect of High Dose Vitamin D on Cancer Biomarkers and Breast Cancer Tumors
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ClinicalTrials.gov Identifier: NCT02856503 |
Recruitment Status :
Withdrawn
(Lack of Funding)
First Posted : August 5, 2016
Last Update Posted : January 18, 2019
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Condition or disease | Intervention/treatment | Phase |
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Breast Cancer Invasive Breast Carcinoma Ductal Carcinoma In-situ | Drug: Vitamin D3 | Phase 1 Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I/II Study Evaluating Safety and Effects of Preoperative High-Dose Vitamin D on the Receptors, Biomarkers and Pathological Characteristics of High Grade DCIS or Invasive Breast Cancer. |
Estimated Study Start Date : | January 2019 |
Estimated Primary Completion Date : | January 2023 |
Estimated Study Completion Date : | January 2024 |

Arm | Intervention/treatment |
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Experimental: Phase 1 - Group A - VD 3 Weeks
Weekly oral dose of 50,000 IU Vitamin D3 (VD) for 3 weeks.
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Drug: Vitamin D3
Weekly oral dose of Vitamin D3 per protocol.
Other Names:
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Active Comparator: Phase 1 - Group B - VD 4 Weeks
Weekly oral dose of 50,000 IU Vitamin D3 (VD) for 4 weeks
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Drug: Vitamin D3
Weekly oral dose of Vitamin D3 per protocol.
Other Names:
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Active Comparator: Phase 1 - Group C - VD 5 Weeks
Weekly oral dose of 50,000 IU Vitamin D3 (VD) for 5 weeks.
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Drug: Vitamin D3
Weekly oral dose of Vitamin D3 per protocol.
Other Names:
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Experimental: Phase 2 - VD
Weekly oral dose of 50,000 IU Vitamin D3 (VD) therapy for the duration selected from the phase I part of the study.
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Drug: Vitamin D3
Weekly oral dose of Vitamin D3 per protocol.
Other Names:
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- Phase 1 - Rate of Treatment-Related Toxicity in Subjects [ Time Frame: From Baseline to 30 days (+ 5 days) After Last Dose of Protocol Therapy, About 3 Months ]Rate of treatment-related adverse events and other toxicities in subjects.
- Phase 2 - Rate of Favorable Treatment Response in Subjects Receiving Protocol Therapy Given Within the Optimal Duration Determined in Phase 1. [ Time Frame: Up to 7 Weeks ]
Rate of subjects achieving a "favorable treatment response" to protocol therapy given within the optimal duration determined in Phase 1. The effect of VD therapy will be assessed in terms of change in expression of VDR, ER, PR, HER2/neu, AR, Ki-67, E-cadherin and EGFR comparing surgical specimen (post-VD treatment) and baseline biopsy specimen (pre-VD treatment). The effect of VD will be described as increased expression, decreased expression or no change in expression of each marker/receptor measured.
The expression of nuclear receptors/proteins (VDR, Ki-67, ER, PR, AR,) will be scored based on the percentage of positively staining nuclei as follows:
- 0 (Negative) if <1%
- +1 (Weak) if >1-10%
- +2 (Moderate) if >10-50%
- +3 (Strong) if >50%
A decrease in the expression of Ki-67 by ≥+1 after treatment is considered a "favorable treatment response".
- Phase 1 - Optimal Duration of Once-Weekly Protocol Therapy [ Time Frame: Up to 7 Weeks ]
The determination of the optimal duration of once-weekly protocol therapy, 3, 4 or 5 weeks, as preoperative treatment to achieve a "favorable" treatment response in subjects with the study disease. The effect of VD therapy will be assessed in terms of change in expression of VDR, ER, PR, HER2/neu, AR, Ki-67, E-cadherin and EGFR comparing surgical specimen (post-VD treatment) and baseline biopsy specimen (pre-VD treatment). The effect of VD will be described as increased expression, decreased expression or no change in expression of each marker/receptor measured.
The expression of nuclear receptors/proteins (VDR, Ki-67, ER, PR, AR,) will be scored based on the percentage of positively staining nuclei as follows:
- 0 (Negative) if <1%
- +1 (Weak) if >1-10%
- +2 (Moderate) if >10-50%
- +3 (Strong) if >50%
A decrease in the expression of Ki-67 by ≥+1 after treatment is considered a "favorable treatment response".
- Phase 2 - Rate of Treatment-Related Toxicity in Subjects [ Time Frame: From Baseline to 30 days (+ 5 days) After Last Dose of Protocol Therapy, About 3 Months ]Rate of treatment-related adverse events and other toxicities in subjects.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients must have histologically confirmed invasive breast carcinoma (IBC) or high grade (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.
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Patients must have normal organ function as defined below:
- Aspartate aminotransferase (AST/SGOT) < 4 times institutional upper limit of normal.
- 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 >/= 60 mL/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 consent document by patient or their legal representatives.
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 participated in any investigational drug study within 4 weeks preceding the start of study treatment.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with 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, Alkaline phosphatase, 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02856503
Principal Investigator: | Eli Avisar, MD | University of Miami |
Responsible Party: | Eli Avisar, Professor, University of Miami |
ClinicalTrials.gov Identifier: | NCT02856503 |
Other Study ID Numbers: |
20150288 |
First Posted: | August 5, 2016 Key Record Dates |
Last Update Posted: | January 18, 2019 |
Last Verified: | January 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
DCIS IBC Breast Cancer Invasive Breast Carcinoma High Grade Ductal Carcinoma in-situ |
Carcinoma Breast Neoplasms Carcinoma in Situ Carcinoma, Ductal Carcinoma, Intraductal, Noninfiltrating Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Adenocarcinoma |
Neoplasms, Ductal, Lobular, and Medullary Breast Carcinoma In Situ Vitamin D Cholecalciferol Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |