Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients

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 his

Trial Details

NCT ID
NCT04677816
Phase
PHASE2
Sponsor
Wake Forest University Health Sciences
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Standard of Care Neoadjuvant Chemotherapy (NAC)
  • Vitamin D3
  • Drug Diary
Locations (sample)
  • Winston-Salem, North Carolina, United States|36.09986,-80.24422

Key Eligibility Criteria

  • Women or men with histologically confirmed invasive mammary carcinoma.
  • Known triple negative ER/PR/HER2 receptor status as defined by:
  • ER and PR less than or equal to 10% and
  • HER2 negative based on one of the following:

For full eligibility, visit ClinicalTrials.gov.

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