Status:
RECRUITING
Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Triple Negative Breast Cancer
Vitamin D Deficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 + vita...
Detailed Description
Primary Objective: To determine if pathologic complete response in vitamin D deficient patients receiving vitamin D supplementation during neoadjuvant chemotherapy for operable triple negative breast ...
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.
Key Trial Info
Start Date :
October 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04677816
Start Date
October 22 2021
End Date
March 1 2026
Last Update
June 27 2025
Active Locations (1)
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1
Wake Forest Baptist Health Sciences
Winston-Salem, North Carolina, United States, 27157