NCT02856503

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

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.

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Eli Avisar, MD · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Vitamin D3	Weekly oral dose of Vitamin D3 per protocol.

Timeline

• Start date: 2019-01-13
• Primary completion: 2023-01-31
• Completion: 2024-04-15
• First posted: 2016-08-05
• Last updated: 2026-04-17

Regulatory

• FDA-regulated drug study