Study of Vitamin D Supplementation During Chemotherapy for Vitamin D Deficient Patients With Operable Triple Negative Breast Cancer to Improve Treatment Response

What this Trial Is About

Researchers are studying the impact of vitamin D supplementation on patients with triple negative breast cancer who also have vitamin D deficiency. The trial aims to see if adding vitamin D to standard neoadjuvant chemotherapy can increase the rate of complete disappearance of cancer detected by pathology, compared to historical data. This phase II study also observes patients with sufficient vitamin D levels to understand their response to chemotherapy. Participants receive standard chemotherapy including doxorubicin, cyclophosphamide, and paclitaxel, with possible carboplatin at the doctors discretion. Those with vitamin D deficiency take 50,000 IU of oral vitamin D3 weekly for 20 weeks alongside chemotherapy. After chemotherapy, surgery is performed to remove the tumor. The study includes an observational group of patients with normal vitamin D levels who receive chemotherapy without supplementation. During the study, participants will regularly report their vitamin D intake using a drug diary. Researchers will monitor cancer response, adverse events, vitamin D receptor changes in tumor tissue, and fecal microbiome changes before and after treatment. Patients will be followed for at least 30 days after treatment or study removal to track safety and outcomes. The main goal is to measure the number of patients who achieve a complete pathologic response within about 22 weeks.

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