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Vitamin D Supplementation for Triple Negative Breast Cancer

This study is looking at whether adding Vitamin D3 to standard chemotherapy (doxorubicin, cyclophosphamide, and paclitaxel) can improve treatment results for people with triple negative breast cancer and low vitamin D levels. You could join if you are an adult with invasive triple negative breast cancer. The study wants to see if vitamin D supplementation increases the number of patients who have a "pathologic complete response" (pCR), meaning no cancer cells are found in the breast and lymph nodes after treatment. The current status of this study is unclear, and it plans to enroll 50 participants.

Study design
This is a pilot study involving two groups of participants. It is designed to enroll 50 participants.
What's involved
If you receive Vitamin D, you will take 50,000 IU of oral Vitamin D3 once a week for 20 weeks during chemotherapy. You will also fill out a daily drug diary.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome (pathologic complete response) is measured up to 22 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04677816

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Wake Forest University Health Sciences
~50 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Standard of Care Neoadjuvant Chemotherapy (NAC)Vitamin D3Drug Diary

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Pathologic Complete Response (pCR) in Vitamin D Supplementation Group
Measured over Up to 22 weeks

Conditions

Triple Negative Breast Cancer
Vitamin D Deficiency
Invasive Breast Cancer

Explore related trials

Breast CarcinomaTriple-negative breast cancer

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Emily H Douglas, MD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences

Who to contact

Study Coordinator
[email protected]
336-716-5772
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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).

Exclusion

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.

What this trial measures

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

    Investigators will determine whether the proportion responding (pCR) is less than or equal to 30% or greater than or equal to 60% using a one-stage phase II design. All participants in the intervention group who are evaluable will be included in the analysis. Pathologic complete response, which is also characterized as residual cancer burden 0, is defined as a final surgical pathologic diagnosis of ypT0 ypN0 or ypTis ypN0. Only the vitamin D deficient patients will be included in the primary statistical analysis.