Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients
Recruiting
Phase 2
Interventional Study
Triple Negative Breast Cancer
Vitamin D Deficiency
Invasive Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 50 (estimated)
- Sponsor
- Wake Forest University Health Sciences · Other
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About This Trial
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 i…
Trial Locations
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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
…
Contacts