Vitamin D Supplementation for Breast Cancer
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Wake Forest University Health Sciences
Stay on your current meds
No Placebo Group
Prior Safety Data
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?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.
Is the treatment of Vitamin D and Neoadjuvant Chemotherapy promising for breast cancer?Yes, combining Vitamin D with Neoadjuvant Chemotherapy seems promising for breast cancer. Studies suggest that Vitamin D can help chemotherapy work better by increasing cancer cell death. Patients with higher Vitamin D levels showed better responses to treatment and improved survival rates.12367
What safety data exists for Vitamin D supplementation in breast cancer treatment?The safety data for Vitamin D supplementation in breast cancer treatment includes findings from a phase II trial where high-dose Vitamin D was administered to patients with early breast cancer receiving adjuvant chemotherapy. The trial reported no Vitamin D-related clinical toxicity, although 29.5% of patients experienced asymptomatic grade 1 hypercalciuria, leading to the interruption of supplementation in some cases. Overall, the high-dose Vitamin D supplementation was considered safe and effective in normalizing Vitamin D levels in these patients.35678
What data supports the idea that Vitamin D Supplementation for Breast Cancer is an effective treatment?The available research shows that Vitamin D supplementation can improve outcomes for breast cancer patients undergoing chemotherapy. Studies indicate that higher levels of Vitamin D are linked to better responses to treatment, such as achieving a complete response where no cancer is detected after treatment. Additionally, Vitamin D supplementation during chemotherapy has been associated with improved long-term outcomes in patients with a specific type of breast cancer. This suggests that Vitamin D can enhance the effectiveness of chemotherapy in treating breast cancer.34567
Do I have to stop taking my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you are currently taking Vitamin D at a dose of 50,000 IU once weekly, you cannot participate in the trial.
Eligibility Criteria
This trial is for adults with triple negative breast cancer who are vitamin D deficient and scheduled for surgery after chemotherapy. They must be in good enough health to participate, agree to use contraception, and have not received prior treatment for their cancer. People with a history of kidney stones, sarcoidosis, high calcium levels, allergies to vitamin D-like compounds or taking high-dose Vitamin D cannot join.Inclusion Criteria
I am 18 years old or older.
I can take care of myself and am up and about more than half of my waking hours.
I have been diagnosed with invasive breast cancer.
My breast cancer is triple negative.
Exclusion Criteria
I have had kidney stones in the past year.
I have had treatments like surgery or chemotherapy for my cancer before joining this study.
I have been diagnosed with sarcoidosis.
I am taking 50,000 IU of Vitamin D weekly.
Treatment Details
The study tests if adding Vitamin D3 supplements to standard neoadjuvant chemotherapy improves the rate at which patients achieve complete absence of cancer in the breast tissue after treatment (pathologic complete response), compared to historical rates in patients with sufficient vitamin D.
2Treatment groups
Experimental Treatment
Active Control
Group I: Vitamin D Supplementation Group - Deficient LevelsExperimental Treatment3 Interventions
Along with standard of care neoadjuvant chemotherapy treatments and procedures, participants will receive oral 50,000 international units of Vitamin D3 supplementation at the initiation of chemotherapy once a week.
Group II: Observational Arm - Vitamin D at Normal LevelsActive Control1 Intervention
Standard of care neoadjuvant chemotherapy
Standard of Care Neoadjuvant Chemotherapy is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Neoadjuvant Chemotherapy for:
- Breast cancer
- Triple-negative breast cancer
🇺🇸 Approved in United States as Neoadjuvant Chemotherapy for:
- Breast cancer
- Triple-negative breast cancer
🇨🇦 Approved in Canada as Neoadjuvant Chemotherapy for:
- Breast cancer
- Triple-negative breast cancer
Find a clinic near you
Research locations nearbySelect from list below to view details:
Wake Forest Baptist Health SciencesWinston-Salem, NC
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
National Cancer Institute (NCI)Collaborator
References
High prevalence of vitamin D deficiency despite supplementation in premenopausal women with breast cancer undergoing adjuvant chemotherapy. [2022]Vitamin D deficiency is associated with increased breast cancer risk and decreased breast cancer survival. The purpose of this study was to determine the prevalence of vitamin D deficiency, as measured by serum 25-hydroxyvitamin D (25-OHD), in premenopausal women at initiation of adjuvant chemotherapy for breast cancer and after 1 year of vitamin D supplementation.
[Vitamin D and breast cancer: physiopathology, biological and clinical implications]. [2014]There is a recent increase in interest of vitamin D and breast cancer, facing the number of publications on the subject. This increase have several reasons, on the one hand, vitamin D deficiency is more and more prevalent and, on the other hand, there are new data that highlights the extra-bone effects of vitamin D, especially in breast cancer, the vitamin D is involved in the breast cancer risk factor, the prognosis, and the interaction with breast cancer treatments. This combination between vitamin D deficiency and breast cancer is extremely usual, and combined with all cancer clinical parameters: the incidence, the tumour biology, the clinical presentation, the prognosis, and the antineoplastic treatment tolerance. This vitamin D deficiency is increased after adjuvant cancer treatments. And yet, this problem increases bone metabolism disruptions in breast cancer patients, inducing osteoporotic risk at long time, even though this population is curable. This problem is therefore serious in the adjuvant breast cancer treatment. Unfortunately, in this population, the current recommendations are clearly insufficient, and the current randomized clinical trial results would contribute to define the best way to correct the vitamin D deficiency, quickly and secure.
Improved clinical outcomes associated with vitamin D supplementation during adjuvant chemotherapy in patients with HER2+ nonmetastatic breast cancer. [2015]Vitamin D (VD) supplementation has pleiotropic effects that extend beyond their impact on bone health, including the disruption of downstream VD receptor signaling and human epidermal growth factor receptor 2 (HER2) signaling through the ErbB2/AKT/ERK pathway. In the present study, we examined our institutional experience with patients having nonmetastatic HER2-positive (HER(+)) breast cancer and hypothesized that those patients who received VD supplementation during neoadjuvant chemotherapy would have improved long-term outcomes.
Vitamin D (25-0H D3) status and pathological response to neoadjuvant chemotherapy in stage II/III breast cancer: Data from the NEOZOTAC trial (BOOG 10-01). [2022]Serum levels of 25-OH vitamin D3 (vitamin D) have been shown to be prognostic for disease-free survival in patients with breast cancer. We investigated the predictive value of these levels for pathological response after neoadjuvant chemotherapy in patients with breast cancer taking part in the NEOZOTAC phase-III trial. Additionally, the effect of chemotherapy on vitamin D levels was studied.
Impact of a tailored oral vitamin D supplementation regimen on serum 25-hydroxyvitamin D levels in early breast cancer patients: a randomized phase III study. [2020]A minority of early breast cancer (EBC) patients treated with adjuvant or neoadjuvant chemotherapy have sufficient baseline vitamin D (vitD) level. This randomized phase III study assessed the safety and efficacy of a tailored, high-dose, oral vitD supplementation in restoring a normal 25-hydroxy vitD (25OHD) level in this population.
Serum Vitamin D Levels Affect Pathologic Complete Response in Patients Undergoing Neoadjuvant Systemic Therapy for Operable Breast Cancer. [2019]There has been increasing interest in the potential benefit of vitamin D in improving breast cancer outcome. Preclinical studies suggest that vitamin D enhances chemotherapy-induced cell death. We investigated the impact of serum vitamin D levels during neoadjuvant chemotherapy (NAC) on the rates of achieving pathologic complete response (pCR) after breast cancer NAC.
Impact of vitamin D on pathological complete response and survival following neoadjuvant chemotherapy for breast cancer: a retrospective study. [2019]There has been interest in the potential benefit of vitamin D (VD) to improve breast cancer outcomes. Pre-clinical studies suggest VD enhances chemotherapy-induced cell death. Vitamin D deficiency was associated with not attaining a pathologic complete response (pCR) following neoadjuvant chemotherapy (NAC) for operable breast cancer. We report the impact of VD on pCR and survival in an expanded cohort.
A Phase II Multicenter Trial on High-Dose Vitamin D Supplementation for the Correction of Vitamin D Insufficiency in Patients with Breast Cancer Receiving Adjuvant Chemotherapy. [2022]Breast cancer (BC) treatments induce vitamin D (VD) insufficiency and bone metabolism changes, resulting in osteoporosis and skeletal morbidity risk. We report the results of a bicentric phase II trial (ClinicalTrials.gov Identifier: NCT04091178) on the safety and efficacy of high-dose oral VD supplementation for VD deficiency correction in 44 patients with early BC treated with adjuvant chemotherapies. Patients received one dose of 100,000 IU 25-OH VD every 3 weeks from day 1 of cycle 1 to day 1 of cycle 5. The primary endpoint was the percentage of patients achieving serum 25-OH VD concentration normalization on day 1 of cycle 6 (D1C6). Secondary endpoints were safety, VD and calcium parameters at baseline and during chemotherapy, and identification of predictive biomarkers of VD normalization on D1C6. On D1C6, 21 patients (47.7%, 95% CI: 33.0-62.8) achieved VD normalization. No VD-related clinical toxicity was reported. However, 13 patients (29.5%) presented asymptomatic grade 1 hypercalciuria, leading to interruption of the high-dose oral VD supplementation in 10, followed by a rapid reduction in serum VD concentration. No baseline clinical factor was predictive of VD normalization on D1C6. This high-dose VD supplementation appears safe and efficient in patients with early BC receiving adjuvant chemotherapy.