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 (May 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
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression ≤10% (≤10%)
ER less than or equal to 10%
Required: PR (PGR) expression ≤10% (≤10%)
PR less than or equal to 10%
Required: HER2 (ERBB2) wild-type (IHC 0 or 1+; or IHC 2+ and FISH negative; or IHC 2+ and FISH equivocal and no indication for HER2 targeted therapy)
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
Prior treatment for this malignancy including surgery, radiation therapy, chemotherapy, hormonal therapy or investigational agent prior to study entry.
Cannot have received: radiation therapy
Prior treatment for this malignancy including surgery, radiation therapy, chemotherapy, hormonal therapy or investigational agent prior to study entry.
Cannot have received: cytotoxic chemotherapy
Prior treatment for this malignancy including surgery, radiation therapy, chemotherapy, hormonal therapy or investigational agent prior to study entry.
Cannot have received: hormonal therapy
Prior treatment for this malignancy including surgery, radiation therapy, chemotherapy, hormonal therapy or investigational agent prior to study entry.
Cannot have received: investigational agent
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
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