This phase II trial studies the effect of vitamin D supplementation in improving pathologic complete response in vitamin D deficient patients who are receiving neoadjuvant chemotherapy for triple negative breast cancer that can be removed by surgery (operable). There is evidence that vitamin D may have anti-cancer properties. This trial aims to see whether adding weekly vitamin D supplementation to standard of care chemotherapy may help to improve treatment response in vitamin D deficient patients.
Additional locations may be listed on ClinicalTrials.gov for NCT04677816.
Locations matching your search criteria
United States
North Carolina
Winston-Salem
Wake Forest University Health SciencesStatus: Active
Contact: Emily Hughes Douglas
Phone: 336-716-4464
PRIMARY OBJECTIVE:
I. To determine if pathologic complete response (pCR) in vitamin D deficient patients receiving vitamin D supplementation during neoadjuvant chemotherapy (NAC) for operable triple negative breast cancer is greater than or equal to 60% or less than or equal to pCR in historical controls (30%) using a one-stage phase II design.
SECONDARY OBJECTIVES:
I. To estimate the proportion of patients with residual cancer burden (RCB) classes I, II, and III in vitamin D deficient patients receiving vitamin D supplementation during NAC for operable triple negative breast cancer.
II. To estimate pCR in the observational arm of vitamin D sufficient patients receiving NAC for operable triple negative breast cancer.
III. To determine the feasibility of delivery of vitamin D supplementation with standard of care chemotherapy.
IV. To determine the safety and tolerability of the combination of vitamin D supplementation with standard of care chemotherapy.
V. To estimate the change in vitamin D receptor (VDR) expression from pre- and post-neoadjuvant treatment breast tumor tissue samples of vitamin D deficient patients.
VI. To estimate the change in VDR expression from pre- to post-neoadjuvant treatment breast tumor tissue samples in a sample of 5 vitamin D sufficient patients.
VII. To estimate the changes in the fecal microbiome of vitamin D deficient patients from pre- to post-neoadjuvant treatment.
VIII. To estimate the changes in the fecal microbiome in a sample of 5 vitamin D sufficient patients from pre- to post-neoadjuvant treatment.
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM I: Vitamin D deficient patients receive vitamin D supplementation orally (PO) once a week for 20 weeks during standard of care NAC including doxorubicin and cyclophosphamide for 4 cycles and paclitaxel weekly for 12 cycles. After completion of NAC, patients undergo standard of care surgery. Patients undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) during screening.
ARM II: Vitamin D sufficient patients receive standard of care NAC including doxorubicin and cyclophosphamide for 4 cycles and paclitaxel weekly for 12 cycles. After completion of NAC, patients undergo standard of care surgery. Patients undergo ECHO or MUGA during screening.
After completion of study treatment, patients are followed up for 30 days.
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorEmily Hughes Douglas
