Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients
Recruiting · NCT04677816 · Interventional (participants receive a specific treatment) · Lead sponsor: Wake Forest University Health Sciences
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed across 1 US state.
- Wake Forest Baptist Health Sciences - Winston-Salem, North Carolina, United States