Effect of High Dose Vitamin D on Cancer Biomarkers and Breast Cancer Tumors (NCT02856503) | Clinical Trial Compass
WithdrawnPhase 1/2
Effect of High Dose Vitamin D on Cancer Biomarkers and Breast Cancer Tumors
Stopped: Lack of Funding
0Started 2019-01-13
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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
✕. 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.
What they're measuring
1
Phase 1 - Rate of Treatment-Related Toxicity in Subjects
Timeframe: From Baseline to 30 days (+ 5 days) After Last Dose of Protocol Therapy, About 3 Months
2
Phase 2 - Rate of Favorable Treatment Response in Subjects Receiving Protocol Therapy Given Within the Optimal Duration Determined in Phase 1.
. 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.