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RecruitingPhase 2

Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients

Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients Receiving Neoadjuvant Chemotherapy for Operable Triple Negative Breast Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 30 days

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients will be followed for 30 days after removal from study or until death, whichever occurs first."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding vitamin D to chemotherapy before surgery helps clear all signs of cancer from tissue checked after surgery. It is for adults with triple-negative breast cancer, especially those with low vitamin D levels. The study also watches how patients without low vitamin D respond.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women or men age 18 or older with breast cancer that has grown into nearby tissue, confirmed by a tissue test.
  • Cancer must meet the study’s triple-negative test rules: ER and PR levels of 10% or less, and HER2 results that meet the study’s limits.
  • Plan to have chemotherapy before surgery. You may join up to 2 weeks after starting chemotherapy.
  • Able to do self-care and be out of bed or a chair for at least half of waking hours, even if you cannot work.
  • If you can become pregnant, agree to use birth control or avoid sex before joining and throughout the study. Tell your doctor right away if you think you are pregnant.
  • Be able to understand and agree to join by signing a consent form, yourself or through a legally authorized representative.

Who can't join

  • Kidney stones within the past year.
  • Known sarcoidosis, a disease that causes small clumps of inflamed tissue.
  • An adjusted blood calcium level above 10.5 mg/dL within 30 days before starting chemotherapy.
  • Past allergic reactions to substances similar to vitamin D.
  • Pregnant.
  • Breastfeeding.
  • Past treatment for this cancer before joining, including surgery, radiation, chemotherapy, hormone therapy, or an experimental drug.
  • Currently taking 50,000 international units (IU) of vitamin D once a week.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 * 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.

Study sites (1)

NC