A Phase 2 Randomized, Double-blind, Window of Opportunity Trial Evaluating Clinical and Correlative Effects of Vitamin D in Patients With Breast Cancer. The ICARUS Trial
Overview
- Phase
- Phase 2
- Intervention
- Vitamin D3
- Conditions
- Breast Cancer
- Sponsor
- Ottawa Hospital Research Institute
- Enrollment
- 83
- Locations
- 1
- Primary Endpoint
- Pre and post vitamin D administration Ki67 levels and Caspase 3 levels (as assessed according to the apoptosis assay)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This protocol is a randomized, phase 2 "window of opportunity" trial assessing the biological effects of short term oral vitamin D administration on breast cancer clinical and translational markers in patients awaiting surgery at the Ottawa Hospital. It takes advantage of the current wait times (2-8 weeks) for breast cancer surgery as a "window of opportunity" to rapidly assess biological changes with vitamin D intake.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed female primary breast cancer patients whose surgery is planned for the next 2-8 weeks without neoadjuvant therapy as assessed by multidisciplinary team
- •Age ≥18 years
- •Clinically palpable tumour(s) (greater than or equal to 2 cm)
- •Normal serum and urine calcium and serum PTH values at baseline (as defined by Ottawa Hospital)
- •Written informed consent for study
Exclusion Criteria
- •Patients with recurrent or metastatic breast cancer
- •History of neoadjuvant hormonal therapy, chemotherapy, or radiation therapy in the last 6 months for their breast cancer or any other cancer treatment
- •ECOG performance Status \> 2
- •Hypercalciuria on initial baseline urine, defined as Ca/Creatinine Ratio\> 1.0
- •Current or previous history of urolithiasis or hyperparathyroidism
- •Abnormal hepatic function according to Ottawa Hospital norms (Total Bilirubin \>2x upper limit of normal, ALT/AST \>3x upper limit of normal)and/or abnormal renal function (Creatinine \> 150 µmol/L)
- •History of granulomatous disease such as tuberculosis or sarcoidosis.
- •Intake of Vitamin D (cholecalciferol) supplement ≥ 2000 IU/day within the last 2 months
- •Inability to comply with a study protocol in the opinion of the investigator (such as abuse of alcohol, drugs or psychotic states).
Arms & Interventions
Vitamin D3
Vitamin D3 40,000 iu per day by mouth
Intervention: Vitamin D3
Placebo
Placebo taken daily by mouth
Intervention: Placebo
Outcomes
Primary Outcomes
Pre and post vitamin D administration Ki67 levels and Caspase 3 levels (as assessed according to the apoptosis assay)
Time Frame: baseline and 2-8 weeks from baseline
Participants will have Ki67 and Caspase 3 levels performed on the tissue that was used to initially diagnose breast cancer. Those levels will then be compared to the tissue acquired at the time of surgery which will occur 2-8 weeks from diagnosis.
Secondary Outcomes
- Serum levels of 25-0HD and in vivo breast (cancer and non cancer) tissue levels of 1,25(OH)(Baseline and 2-8 weeks from baseline at the time of surgery)