Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About this trial
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.
Eligibility criteria
Qualifiers
Women or men with histologically confirmed invasive mammary carcinoma.
ER and PR less than or equal to 10% and
IHC 0 or 1+
IHC 2+ and FISH negative
Disqualifiers
Patients with nephrolithiasis within the past year.
Patients with known sarcoidosis.
Patients with corrected calcium >10.5 mg/dL within 30 days prior to initiation of chemotherapy.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to vitamin D.
Trial design
Treatments tested in this trial
- Standard of Care Neoadjuvant Chemotherapy (NAC)
- Vitamin D3
- Drug Diary
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Wake Forest University Health Sciences
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov