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About
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.
Full 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.
Sex
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Volunteers
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.
Patients must have normal organ function as defined below:
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
Primary purpose
Allocation
Interventional model
Masking
0 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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