Actively Recruiting
Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients Receiving Neoadjuvant Chemotherapy for Operable Triple Negative Breast Cancer
Led by Wake Forest University Health Sciences · Updated on 2026-04-14
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
W
Wake Forest University Health Sciences
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
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 doctor's 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.
CONDITIONS
Brief Title
Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women or men with confirmed invasive mammary carcinoma
- Triple negative breast cancer defined by ER and PR ≤10% and HER2 negative by specific tests
- Planned neoadjuvant chemotherapy before surgery or started chemotherapy within last 2 weeks
- ECOG performance status 0, 1, or 2
- Age 18 years or older
- Women of childbearing potential must use contraception during study
- Ability and willingness to sign informed consent
You will not qualify if you...
- History of kidney stones within the past year
- Known sarcoidosis
- Corrected calcium level >10.5 mg/dL within 30 days before chemotherapy
- Allergic reactions to vitamin D or similar compounds
- Pregnant or breastfeeding women
- Prior treatment (surgery, radiation, chemotherapy, hormonal therapy, or investigational agents) for this cancer before study entry
- Current use of vitamin D at 50,000 IU once weekly or higher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 20 weeks
Participants receive standard of care neoadjuvant chemotherapy and those with vitamin D deficiency also receive weekly vitamin D3 supplementation for 20 weeks during chemotherapy.
Weekly visits for up to 20 weeks
Duration - 1 to 2 weeks
Participants undergo definitive breast surgery following completion of chemotherapy.
1 visit (in-person) for surgery and immediate recovery
Duration - At least 30 days
Participants are monitored for adverse events and safety for at least 30 days after the last study intervention or until resolution or stabilization of any adverse events.
Approximately 1 to 2 visits depending on adverse event resolution
Trial Site Locations
Total: 1 location
1
Wake Forest Baptist Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
S
Study Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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