Recruiting
Phase 2

Vitamin D

Sponsor:

Wake Forest University Health Sciences

Code:

NCT04677816

Conditions

Triple Negative Breast Cancer

Vitamin D Deficiency

Invasive Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard of Care Neoadjuvant Chemotherapy (NAC)

Vitamin D3

Drug Diary

Study Details

Brief summary:

A two arm pilot study investigating the rate of pathologic complete response in patients with vitamin D deficiency and triple negative breast cancer undergoing standard neoadjuvant chemotherapy + vitamin D supplementation, including an observational arm to describe response in patients who are not deficient. Investigators hypothesize that vitamin D supplementation during neoadjuvant chemotherapy in operable triple negative breast cancer patients with vitamin D deficiency will increase the rate of pathologic complete response chain reaction to that of vitamin D sufficient patients based on historical controls.

Conditions

Triple Negative Breast Cancer

Vitamin D Deficiency

Invasive Breast Cancer

Study ID

NCT04677816

Start date

Oct 22, 2021

Status verified date

Aug, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Vitamin D Supplementation Group - Deficient Levels

Along with standard of care neoadjuvant chemotherapy treatments and procedures, participants will receive oral 50,000 international units of Vitamin D3 supplementation at the initiation of chemotherapy once a week.

active comparator: Observational Arm - Vitamin D at Normal Levels

Standard of care neoadjuvant chemotherapy

Interventions

Standard of Care Neoadjuvant Chemotherapy (NAC)

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

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

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.

Primary outcome measure

  • Number of Pathologic Complete Response (pCR) in Vitamin D Supplementation Group [ Time Frame: Up to 22 weeks ]

Central Contacts and Locations

Central contacts

Study Coordinator

336-716-5772Brandy.Baker@advocatehealth.org

Locations

Wake Forest Baptist Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Study Coordinator

336-716-5772Brandy.Baker@advocatehealth.org

Principal Investigator:

Emily H Douglas, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-08-28.