Vitamin D supplementation for patients with triple negative breast cancer
Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients Receiving Neoadjuvant Chemotherapy for Operable Triple Negative Breast Cancer
This study is testing if giving vitamin D to patients with triple negative breast cancer who are low in vitamin D can help them respond better to chemotherapy compared to those who have enough vitamin D.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT04677816 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the impact of vitamin D supplementation on the rate of pathologic complete response in patients with vitamin D deficiency undergoing neoadjuvant chemotherapy for operable triple negative breast cancer. It includes two arms: one for patients receiving vitamin D supplementation and another observational arm for vitamin D sufficient patients. The primary objective is to determine if the pathologic complete response rate in vitamin D deficient patients receiving supplementation is greater than historical controls. Secondary objectives include assessing residual cancer burden, safety, tolerability, and changes in vitamin D receptor expression and microbiomes.
Who should consider this trial
Good fit: Ideal candidates include adults with histologically confirmed invasive triple negative breast cancer and vitamin D deficiency who are scheduled for neoadjuvant chemotherapy.
Not a fit: Patients with non-triple negative breast cancer or those who are vitamin D sufficient may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment outcomes for patients with triple negative breast cancer by improving response rates through vitamin D supplementation.
How similar studies have performed: While the specific combination of vitamin D supplementation with neoadjuvant chemotherapy is novel, previous studies have suggested potential benefits of vitamin D in cancer treatment.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest Baptist Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Emily H Douglas, MD — Wake Forest University Health Sciences
- Study coordinator: Study Coordinator
- Email: jwyche@wakehealth.edu
- Phone: 336-713-0031
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.