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

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Dec 15, 2020

Keywords

ClinConnect Summary

This clinical trial is studying whether taking vitamin D supplements can improve treatment outcomes for patients with a specific type of breast cancer called triple negative breast cancer, especially those who are low in vitamin D. The researchers believe that by giving vitamin D to patients during their chemotherapy treatment, they might have a better chance of having no signs of cancer left after treatment, compared to those who have enough vitamin D. The trial is currently recruiting participants, and it aims to compare two groups: one group will receive vitamin D supplements along with their chemotherapy, while the other group will be observed without the supplements.

To be eligible for this study, participants must be adults (18 years and older) with confirmed triple negative breast cancer who are scheduled to have surgery after their chemotherapy. They should also be low in vitamin D but not have any serious health issues that could complicate their treatment, such as certain kidney problems or past treatments for breast cancer. Throughout the study, participants will receive standard care, and those in the vitamin D group will take the supplements as part of their treatment plan. It's important to note that women who are pregnant or breastfeeding cannot participate due to unknown risks. Participants will also need to understand and agree to the study's terms before joining.

Gender

ALL

Eligibility 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 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.