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Vitamin d breast cancer study pulled before it began

NCT ID NCT02856503

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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 However, the study was withdrawn before any participants were enrolled, so no results are available.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

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.

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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.

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