Clinical trial · Interventional
Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Invasive Breast Cancer | Invasive Breast Carcinoma | ALIAS | 0.90 |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
| Vitamin D Deficiency | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drug Diary | Other | — | UNRESOLVED |
| Standard of Care Neoadjuvant Chemotherapy (NAC) | Drug | — | UNRESOLVED |
| Vitamin D3 | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vitamin D Supplementation Group - Deficient Levels
- description
- Along with standard of care neoadjuvant chemotherapy treatments and procedures, participants will receive oral 50,000 international units of Vitamin D3 supplementation at the initiation of chemotherapy once a week.
- interventionNames
- Drug: Standard of Care Neoadjuvant Chemotherapy (NAC)
- Dietary Supplement: Vitamin D3
- Other: Drug Diary
- type
- ACTIVE_COMPARATOR
- label
- Observational Arm - Vitamin D at Normal Levels
- description
- Standard of care neoadjuvant chemotherapy
- interventionNames
- Drug: Standard of Care Neoadjuvant Chemotherapy (NAC)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available