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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• 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:
• IHC 0 or 1+
• IHC 2+ and FISH negative
• IHC 2+ and FISH equivocal and no indication for HER2 targeted therapy based on the treating investigators discretion (i.e., HER2: CEP17 ratio < 2.0 or HER2 total copy number <6)
• Patients who plan to undergo neoadjuvant chemotherapy prior to definitive surgical management. Participants are eligible up to 2 weeks after initiating neoadjuvant chemotherapy.
• ECOG performance status of 0, 1 or 2.
• Age ≥ 18.
• The effects of high dose vitamin D on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).

You cannot join if

• 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.
• Pregnant women are excluded from this study because vitamin D supplementation greater than the recommended daily allowance (RDA) is a pregnancy class C agent with no adequate or well controlled studies in humans.
• Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with high dose vitamin D (greater than RDA), women who are breastfeeding are excluded from this study.
• Prior treatment for this malignancy including surgery, radiation therapy, chemotherapy, hormonal therapy or investigational agent prior to study entry.
• Patients currently taking Vitamin D at a dose of 50,000 International Units (IU) once weekly.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

cholecalciferol. A steroid hormone produced in the skin when exposed to ultraviolet light or obtained from dietary sources. The active form of cholecalciferol, 1,25-dihydroxycholecalciferol (calcitriol) plays an important role in maintaining blood calcium and phosphorus levels and mineralization of bone. The activated form of cholecalciferol binds to vitamin D receptors and modulates gene expression. This leads to an increase in serum calcium concentrations by increasing intestinal absorption of phosphorus and calcium, promoting distal renal tubular reabsorption of calcium and increasing osteoclastic resorption. NCI Drug Dictionary

Treatments listed in the registry

• Standard of Care Neoadjuvant Chemotherapy (NAC) (Drug): Participants will receive standard of care neoadjuvant chemotherapy with doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2) for 4 cycles and paclitaxel (80 mg/m2) weekly for 12 cycles. Doxorubicin and cyclophosphamide (AC) may be administered on a classical every 3 week or dose dense every 2-week (with growth factor support) schedule at the treating physician's discretion. Routine incorporation of carboplatin is not required, however use of carboplatin (AUC 1.5 to 2 weekly or AUC 6 on week 1, 4, 7, and 10) with paclitaxel is allowed at the treating investigator's discretion. Upon completion of neoadjuvant chemotherapy, all patients will undergo definitive surgery with either breast conservation or mastectomy with axillary lymph node staging. Type of surgery will be determined by the treating physician.
• Vitamin D3 (Dietary Supplement): Participants with deficient levels of vitamin D will receive vitamin D supplementation at the initiation of chemotherapy with 50,000 IU of oral vitamin D3 (cholecalciferol) once a week to be continued for 20 weeks during neoadjuvant chemotherapy.
• Drug Diary (Other): Participants that will receive Vitamin D will be asked to fill out a drug diary on a daily basis. Compliance and feasibility will be assessed through a drug diary and pill counts at set time points.

Non Randomized · Parallel · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• surgery: Part of the study plan

Main goals

• Number of Pathologic Complete Response (pCR) in Vitamin D Supplementation Group (Up to 22 weeks)

Other goals

• Number of Participants with Residual Cancer Burden (RCB) Index - Vitamin D Supplementation Group
• Number of Participants with Residual Cancer Burden (RCB) Index - Observational Arm
• Feasibility of Delivery of Standard NAC and Vitamin D Supplementation - Accrual Rate
• Feasibility of Delivery of Standard NAC and Vitamin D Supplementation - Participation Rate
• Feasibility of Delivery of Standard NAC and Vitamin D Supplementation - Retention Rate
• Feasibility of Delivery of Standard NAC and Vitamin D Supplementation - Adherence Rate
• Number of Adverse Events
• Change in Vitamin D Receptor (VDR) Expression
• Change in Fecal Microbiomes

Planned enrollment: 50 (estimated).

• Wake Forest Baptist Health Sciences, Winston-Salem, North Carolina

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT04677816
• NCI Drug Dictionary: C48194

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Aug 27, 2026. Public record; not medical advice.