drugset / Trial / NCT04677816
Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients
Phase 2
Recruiting
50 enrolled
Wake Forest University Health Sciences
National Cancer Institute (NCI) · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
A two arm pilot study investigating the rate of pathologic complete response in patients with vitamin D deficiency and triple negative breast cancer undergoing standard neoadjuvant chemotherapy + vitamin D supplementation, including an observational arm to describe response in patients who are not deficient. Investigators hypothesize that vitamin D supplementation during neoadjuvant chemotherapy in operable triple negative breast cancer patients with vitamin D deficiency, will increase the rate of pathologic complete response chain reaction to that of vitamin D sufficient patients based on historical controls.
Timeline
- Start
- 2021-10-22
- Primary completion
- 2026-08
- Completion
- 2026-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cholecalciferol | Other / unclassified | 50000 iu | Oral |
| Background | Carboplatin | Small molecule | 1.5 unknown | — |
| Background | Carboplatin | Small molecule | 2 unknown | — |
| Background | Carboplatin | Small molecule | 6 unknown | — |
| Background | Cyclophosphamide | Other / unclassified | 600 mg/m2 | — |
| Background | Doxorubicin | Other / unclassified | 60 mg/m2 | — |
| Background | Paclitaxel | Small molecule | 80 mg/m2 | — |