Clinical trial NCT01948128: Effects of Vitamin D in Patients With Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Breast
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Breast Cancer Foundation
First posted: 2013-09-23
Enrollment: 83
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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
2. Age ≥18 years
3. Clinically palpable tumour(s) (greater than or equal to 2 cm)
4. Normal serum and urine calcium and serum PTH values at baseline (as defined by Ottawa Hospital)
5. Written informed consent for study

Exclusion Criteria:

1. Patients with recurrent or metastatic breast cancer
2. History of neoadjuvant hormonal therapy, chemotherapy, or radiation therapy in the last 6 months for their breast cancer or any other cancer treatment
3. ECOG performance Status \> 2
4. Hypercalciuria on initial baseline urine, defined as Ca/Creatinine Ratio\> 1.0
5. Current or previous history of urolithiasis or hyperparathyroidism
6. 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)
7. History of granulomatous disease such as tuberculosis or sarcoidosis.
8. Intake of Vitamin D (cholecalciferol) supplement ≥ 2000 IU/day within the last 2 months
9. Inability to comply with a study protocol in the opinion of the investigator (such as abuse of alcohol, drugs or psychotic states).

Primary outcomes:
measure: Pre and post vitamin D administration Ki67 levels and Caspase 3 levels (as assessed according to the apoptosis assay)
timeFrame: baseline and 2-8 weeks from baseline
Secondary outcomes:
measure: Serum levels of 25-0HD and in vivo breast (cancer and non cancer) tissue levels of 1,25(OH)
timeFrame: Baseline and 2-8 weeks from baseline at the time of surgery
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital Woman's Breast Health Centre
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Angel Arnaout, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arnaout A, Robertson S, Pond GR, Vieth R, Jeong A, Hilton J, Ramsey T, Clemons M. Randomized window of opportunity trial evaluating high-dose vitamin D in breast cancer patients. Breast Cancer Res Treat. 2019 Nov;178(2):347-356. doi: 10.1007/s10549-019-05392-9. Epub 2019 Aug 9.