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

• Status: Recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cholecalciferol; Vitamin D

Criteria

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 < 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 are scheduled to undergo definitive surgical treatment with lumpectomy or mastectomy with axillary lymph node staging after 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.