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

NCT ID: NCT02856503

Last Updated: 2019-01-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-31
• Study Completion Date: 2024-01-31

Brief 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.

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.

Conditions

Breast Cancer; Invasive Breast Carcinoma; Ductal Carcinoma In-situ

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1 - Group A - VD 3 Weeks

Weekly oral dose of 50,000 IU Vitamin D3 (VD) for 3 weeks.

Group Type: EXPERIMENTAL

Vitamin D3

Intervention Type: DRUG

Weekly oral dose of Vitamin D3 per protocol.

Phase 1 - Group B - VD 4 Weeks

Weekly oral dose of 50,000 IU Vitamin D3 (VD) for 4 weeks

Group Type: ACTIVE_COMPARATOR

Vitamin D3

Intervention Type: DRUG

Weekly oral dose of Vitamin D3 per protocol.

Phase 1 - Group C - VD 5 Weeks

Weekly oral dose of 50,000 IU Vitamin D3 (VD) for 5 weeks.

Group Type: ACTIVE_COMPARATOR

Vitamin D3

Intervention Type: DRUG

Weekly oral dose of Vitamin D3 per protocol.

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.

Group Type: EXPERIMENTAL

Vitamin D3

Intervention Type: DRUG

Weekly oral dose of Vitamin D3 per protocol.

Interventions

Vitamin D3

Weekly oral dose of Vitamin D3 per protocol.

Intervention Type: DRUG

Other Intervention Names

Toxiferol; Cholecalciferol

Eligibility Criteria

Inclusion Criteria

1. Patients must have histologically confirmed invasive breast carcinoma (IBC) or high grade (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 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

6. 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.

7. Ability to understand and the willingness to sign a written informed consent document by patient or their legal representatives.

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 participated in any investigational drug study within 4 weeks preceding the start of study treatment.

6. 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.

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, Alkaline phosphatase, 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eli Avisar

OTHER

Sponsor Role: lead

Responsible Party

Eli Avisar

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Eli Avisar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Other Identifiers

20150288

Identifier Type: -

Identifier Source: org_study_id