Vitamin d breast cancer study pulled before it began
NCT ID NCT02856503
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study planned to give high doses of vitamin D to women with breast cancer before their surgery. Researchers wanted to see if the vitamin would change certain markers in the cancer cells. However, the study was withdrawn before any participants were enrolled, so no results are available.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Started
-
Jan 2019
- Finished
-
Apr 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients must have histologically confirmed invasive breast carcinoma (IBC) or high grade (DIN3) Ductal Carcinoma in-situ (DCIS) and be scheduled for primary surgery. 2. Patients must be recommended/scheduled for primary surgery. 3. Female patients 18 years of age or older. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. 5. Patients must have normal organ function as defined below: * Aspartate aminotransferase (AST/SGOT) \< 4 times institutional upper limit of normal. * Alanine transaminase (ALT/SGPT) \< 4 times institutional upper limit of normal. * Serum Bilirubin \< 1.5 mg/dl. * Serum Alkaline Phosphatase \< 4 times institutional upper limit. * Creatinine within normal institutional limits OR; Creatinine clearance \>/= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal. * Albumin within normal institutional limits 6. Women of childbearing potential (WoCBP) must have a negative (serum or urine) pregnancy test and agree to use barrier contraception while on treatment and for 30-days thereafter. 7. Ability to understand and the willingness to sign a written informed consent document by patient or their legal representatives. Exclusion Criteria: 1. Previous history of breast cancer diagnosis or treatment. 2. Synchronous bilateral breast cancer. 3. Metastatic breast cancer 4. Patients recommended for neoadjuvant systemic therapy. 5. Patients may not be receiving any other investigational agents or have participated in any investigational drug study within 4 weeks preceding the start of study treatment. 6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements. 7. Concurrent other malignancy 8. Uncontrolled hypertension 9. Chronic cholestatic or alcoholic liver disease 10. Chronic pancreatitis 11. Kidney impairment or renal stones 12. History of parathyroidectomy 13. Hypercalcemia, defined as serum level \>11 mg/dl. 14. Abnormal laboratory data for: AST (SGOT), ALT (SGPT), Serum Bilirubin, Alkaline phosphatase, Creatinine and/or Creatinine clearance, and Albumin. 15. Patients receiving medications that are incompatible with VD. 16. Prior or known allergic reaction(s) to Vitamin D or other forms of Vitamin D. 17. Female patients who are pregnant or breast feeding.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Breast cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a faster radiation course match the standard one after breast reconstruction?
- Can High-Risk breast cancer patients skip an extra radiation boost?
- Radioactive probe lights up CD73 on breast tumors in PET scans
- Can time with horses help cancer patients feel better?
- Can an oral drug replace injections for advanced breast cancer?
- Can a common steroid shield breast cancer patients from a dangerous drug side effect?