Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Other | — | UNRESOLVED |
| Vitamin D3 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vitamin D3
- description
- Vitamin D3 40,000 iu per day by mouth
- interventionNames
- Drug: Vitamin D3
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo taken daily by mouth
- interventionNames
- Other: Placebo
Primary outcomes (1)
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (1)
- DERIVEDArnaout 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. PMID 31399931