Spots Global Cancer Trial Database for Effect of High Dose Vitamin D on Cancer Biomarkers and Breast Cancer Tumors

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Trial Identification

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

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.

Study ID: NCT02856503

Conditions

Breast Cancer

Invasive Breast Carcinoma

Ductal Carcinoma In-situ

Interventions

Vitamin D3

Study Description

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.