Effects of High Dose Calcitriol in Breast Cancer Patients
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|ClinicalTrials.gov Identifier: NCT01293682|
Recruitment Status : Active, not recruiting
First Posted : February 10, 2011
Last Update Posted : April 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Calcitriol||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of the Effects of High-Dose Oral Calcitriol in Breast Cancer Patients Prior to Surgery|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||October 2020|
In pill form, 45 micrograms once a week for 12 weeks
Other Name: Rocatrol
- efficacy and feasibility of Calcitriol 45 μg [ Time Frame: 12 weeks ]
To collect data on the efficacy and feasibility of Calcitriol 45 μg for maintaining proper bone health among invasive breast cancer patients for a period of 12 weeks.
To collect preliminary data on the effect of Calcitriol 45 μg on bone resorption, as measured by Cross-Linked N-Telopeptide of Type I collagen (NTx) in invasive breast cancer patients over the course of 12 weeks.
To collect preliminary data on the effect of Calcitriol 45 μg on markers of bone formation, as measured by bone-specific alkaline phosphatase (BAP) in invasive breast cancer patients over the course of 12 weeks.
- preliminary data on the effect of pre-surgical Calcitriol 45 μg therapy on tumor cell apoptosis [ Time Frame: 12 weeks ]To collect preliminary data on the effect of pre-surgical Calcitriol 45 μg therapy on tumor cell apoptosis (caspase 3 and survivin), tumor cell proliferation (Ki-67), tumor invasiveness (ER α, PgR, VDR, EGFR, HER2, VEGF, and IGFR), 1α,25(OH)2D3, and Mammostrat Recurrence Score in invasive breast cancer patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01293682
|United States, New York|
|University of Rochester|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Luke J Peppone, PhD||University of Rochester|
|Study Director:||Joseph J Guido, MS||Univ of Rochester|