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.
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…
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.
Trial Locations
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City
State
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Status
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…
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.
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