Breast CancerPhase 1/2NCT02856503
Effect of High Dose Vitamin D on Cancer Biomarkers and Breast Cancer Tumors
A Phase 1/2 study testing Vitamin D3 in people with Breast Cancer and Invasive Breast Carcinoma, run by Eli Avisar, MD.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Invasive Breast Carcinoma, Ductal Carcinoma In-situ
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 13 Jan 2019to 15 Apr 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patients must have normal organ function as defined below:
- Aspartate aminotransferase (AST/SGOT) < 4 times institutional upper limit of normal.
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- 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.
Who cannot join
- 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.
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- 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.
About this study
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.
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.
Read the detailed 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.
- Being tested
- Vitamin D3
- Keywords
- DCIS, IBC, Breast Cancer, Invasive Breast Carcinoma, High Grade Ductal Carcinoma in-situ
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Also called Toxiferol, Cholecalciferol
Weekly oral dose of Vitamin D3 per protocol.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 - Group A - VD 3 Weeks | Experimental | Weekly oral dose of 50,000 IU Vitamin D3 (VD) for 3 weeks. Receives: Drug: Vitamin D3 |
| Phase 1 - Group B - VD 4 Weeks | Active comparator | Weekly oral dose of 50,000 IU Vitamin D3 (VD) for 4 weeks Receives: Drug: Vitamin D3 |
| Phase 1 - Group C - VD 5 Weeks | Active comparator | Weekly oral dose of 50,000 IU Vitamin D3 (VD) for 5 weeks. Receives: Drug: Vitamin D3 |
| Phase 2 - VD | Experimental | Weekly oral dose of 50,000 IU Vitamin D3 (VD) therapy for the duration selected from the phase I part of the study. Receives: Drug: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 - Rate of Treatment-Related Toxicity in Subjects
Rate of treatment-related adverse events and other toxicities in subjects.
Measured: From Baseline to 30 days (+ 5 days) After Last Dose of Protocol Therapy, About 3 Months
Phase 2 - Rate of Favorable Treatment Response in Subjects Receiving Protocol Therapy Given Within the Optimal Duration Determined in Phase 1.
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".
Measured: Up to 7 Weeks
Secondary outcomes (2)
Phase 1 - Optimal Duration of Once-Weekly Protocol Therapy
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".
Measured: Up to 7 Weeks
Phase 2 - Rate of Treatment-Related Toxicity in Subjects
Rate of treatment-related adverse events and other toxicities in subjects.
Measured: From Baseline to 30 days (+ 5 days) After Last Dose of Protocol Therapy, About 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study start13 Jan 2019
- Primary completion31 Jan 2023
- Study completion15 Apr 2024
Why it stopped: Lack of Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Avisar, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eli Avisar, MD, University of Miami
- Investigators
- Eli Avisar, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856503
- Sponsor's protocol ID
- 20150288
- Status last verified
- Apr 2026
- First submitted
- 2 Aug 2016
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02856503
- Acronym / sponsor ID
- 20150288
- Keywords
- DCIS, IBC, Breast Cancer, Invasive Breast Carcinoma, High Grade Ductal Carcinoma in-situ
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eli Avisar, MDUniversity, hospital or other
- Study start
- 13 Jan 2019 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 5 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 1 - Group A - VD 3 Weeks | Experimental | Drug: Vitamin D3Weekly oral dose of 50,000 IU Vitamin D3 (VD) for 3 weeks. |
| Phase 1 - Group B - VD 4 Weeks | Active comparator | Drug: Vitamin D3Weekly oral dose of 50,000 IU Vitamin D3 (VD) for 4 weeks |
| Phase 1 - Group C - VD 5 Weeks | Active comparator | Drug: Vitamin D3Weekly oral dose of 50,000 IU Vitamin D3 (VD) for 5 weeks. |
| Phase 2 - VD | Experimental | Drug: Vitamin D3Weekly oral dose of 50,000 IU Vitamin D3 (VD) therapy for the duration selected from the phase I part of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
- Patients must have normal organ function as defined below:
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Also: Toxiferol, CholecalciferolWeekly oral dose of Vitamin D3 per protocol. | Drug | Phase 1 - Group A - VD 3 Weeks, Phase 1 - Group B - VD 4 Weeks, Phase 1 - Group C - VD 5 Weeks, Phase 2 - VD |
Primary outcome
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".
2 secondary outcomes
Phase 1 - Optimal Duration of Once-Weekly Protocol Therapy
Time frame: Up to 7 Weeks
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eli Avisar, MD principal investigator
University of Miami
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vitamin D3 in people with Breast Cancer and Invasive Breast Carcinoma, run by Eli Avisar, MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.