Effects of Vitamin D in Patients With Breast Cancer

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01948128

Acronym

OTT 12-06

Enrollment

Registered

2013-09-23

Start date

2013-10-31

Completion date

2015-09-30

Last updated

2016-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast

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.

Interventions

DRUGVitamin D3

Participants will take 4 capsules of Vitamin D which equals 40,000 IU by mouth daily during the wait time between diagnosis and surgery.

OTHERPlacebo

Participants will take 4 capsules of placebo by mouth daily during the wait time between diagnosis and surgery.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Pre and post vitamin D administration Ki67 levels and Caspase 3 levels (as assessed according to the apoptosis assay)	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

Measure	Time frame	Description
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	Participant will have Serum levels of 25-0HD and in vivo breast cancer tissue levels of 1,25(OH) taken at baseline and surgery

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026