RECRUITING

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

Conditions

Triple Negative Breast Cancer Vitamin D Deficiency Invasive Breast Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-10-22

Study Completion:2025-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04677816

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 are scheduled to undergo definitive surgical treatment with lumpectomy or mastectomy with axillary lymph node staging after 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).	* 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.

Inclusion Criteria

Exclusion 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 are scheduled to undergo definitive surgical treatment with lumpectomy or mastectomy with axillary lymph node staging after 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).

* 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.

Contacts and Locations

Study Contact

Study Nurse

CONTACT

336-713-3155

anhowell@wakehealth.edu

Principal Investigator

Emily H Douglas, MD

PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Study Locations (Sites)

Wake Forest Baptist Health Sciences

Winston-Salem, North Carolina, 27157

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Emily H Douglas, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-22

Study Completion Date2025-03

Study Record Updates

Study Start Date2021-10-22

Study Completion Date2025-03

Terms related to this study

Additional Relevant MeSH Terms

Triple Negative Breast Cancer
Vitamin D Deficiency
Invasive Breast Cancer