Vitamin D Supplementation for Triple Negative Breast Cancer

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.
Ready to participate?

Review the details below, then apply to join this clinical 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
Who this trial is looking for

This trial is looking for people with triple negative breast cancer who have low levels of vitamin D. Participants will receive standard chemotherapy along with vitamin D supplements to see if this combination improves treatment response.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with invasive breast cancer.
  • I have triple negative breast cancer.
  • I plan to start chemotherapy before surgery.
  • I am at least 18 years old.
  • I have a good performance status (ECOG 0, 1, or 2).
  • I use effective birth control if I can get pregnant.
  • I can understand and sign the consent form.

You may not be able to join if

  • I have had kidney stones in the past year.
  • I have sarcoidosis.
  • I have high calcium levels.
  • I have had allergies to vitamin D.
  • I am pregnant.
  • I am breastfeeding.
  • I have received treatment for breast cancer before this study.
  • I am taking high doses of vitamin D.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

Check Your Eligibility
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
Loading…

Loading trial locations…

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 * I…
Contacts

Study Coordinator

336-716-5772

Brandy.Baker@advocatehealth.org

CONTACT