OncoMatch/Clinical Trials/NCT04677816
Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients
Is NCT04677816 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies Standard of Care Neoadjuvant Chemotherapy (NAC) for triple negative breast cancer.
Treatment: Standard of Care Neoadjuvant Chemotherapy (NAC) — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression (≤10%)
ER less than or equal to 10%
Required: PR (PGR) expression (≤10%)
PR less than or equal to 10%
Required: HER2 (ERBB2) wild-type (negative)
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
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: surgery for this malignancy
Prior treatment for this malignancy including surgery, radiation therapy, chemotherapy, hormonal therapy or investigational agent prior to study entry
Cannot have received: radiation therapy for this malignancy
Prior treatment for this malignancy including surgery, radiation therapy, chemotherapy, hormonal therapy or investigational agent prior to study entry
Cannot have received: chemotherapy for this malignancy
Prior treatment for this malignancy including surgery, radiation therapy, chemotherapy, hormonal therapy or investigational agent prior to study entry
Cannot have received: hormonal therapy for this malignancy
Prior treatment for this malignancy including surgery, radiation therapy, chemotherapy, hormonal therapy or investigational agent prior to study entry
Cannot have received: investigational agent for this malignancy
Prior treatment for this malignancy including surgery, radiation therapy, chemotherapy, hormonal therapy or investigational agent prior to study entry
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Wake Forest Baptist Health Sciences · Winston-Salem, North Carolina
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04677816 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify