RecruitingPhase 2NCT04677816

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


Sponsor

Wake Forest University Health Sciences

Enrollment

50 participants

Start Date

Oct 22, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving Vitamin D supplements to patients who are deficient in Vitamin D can improve the chance of achieving a complete pathological response (meaning no cancer cells found at surgery) in patients with triple-negative breast cancer (TNBC) receiving chemotherapy before surgery (neoadjuvant chemotherapy). TNBC is a more aggressive type of breast cancer that lacks three common receptors targeted by standard treatments. **You may be eligible if you:** - Have been confirmed with invasive triple-negative breast cancer (ER-negative, PR-negative, HER2-negative) - Are planning to receive or have recently started neoadjuvant (pre-surgery) chemotherapy - Are in good health (ECOG 0–2) **You may NOT be eligible if you:** - Do not have triple-negative breast cancer - Have already completed neoadjuvant chemotherapy - Are not planning surgery after chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGStandard of Care Neoadjuvant Chemotherapy (NAC)

Participants will receive standard of care neoadjuvant chemotherapy with doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2) for 4 cycles and paclitaxel (80 mg/m2) weekly for 12 cycles. Doxorubicin and cyclophosphamide (AC) may be administered on a classical every 3 week or dose dense every 2-week (with growth factor support) schedule at the treating physician's discretion. Routine incorporation of carboplatin is not required, however use of carboplatin (AUC 1.5 to 2 weekly or AUC 6 on week 1, 4, 7, and 10) with paclitaxel is allowed at the treating investigator's discretion. Upon completion of neoadjuvant chemotherapy, all patients will undergo definitive surgery with either breast conservation or mastectomy with axillary lymph node staging. Type of surgery will be determined by the treating physician.

DIETARY_SUPPLEMENTVitamin D3

Participants with deficient levels of vitamin D will receive vitamin D supplementation at the initiation of chemotherapy with 50,000 IU of oral vitamin D3 (cholecalciferol) once a week to be continued for 20 weeks during neoadjuvant chemotherapy.

OTHERDrug Diary

Participants that will receive Vitamin D will be asked to fill out a drug diary on a daily basis. Compliance and feasibility will be assessed through a drug diary and pill counts at set time points.


Locations(1)

Wake Forest Baptist Health Sciences

Winston-Salem, North Carolina, United States

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NCT04677816


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