Vitamin D Can Increase Pathological Response of the Breast Cancer Patients Treated With Neoadjuvant Therapy

Study Overview
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Brief Summary
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The aim of the study is to evaluate the relationship between the vitamin D replacement and pathological response in patients undergoing neoadjuvant therapy according to different molecular sub types. Because of no study evaluating pathological response to neoadjuvant therapy with vitamin D replacement in patients with breast cancer.

Detailed Description
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Calcitriol, a vitamin D metabolite, inhibits cell proliferation and pathways in invitro experiments. Vitamin D affects gene expression related to breast cancer and prevents cell differentiation, growth and angiogenesis . Low vitamin D may include a high risk of breast cancer, but there are also studies reporting that patients with low vitamin D levels at the time of diagnosis show more aggressive breast cancer course . Breast cells can produce vitamin D by taking part in the formation of 1,25 OH vit D3 in vitamin D synthesis as well as in kidney cells. Apoptosis can be caused by vitamin D receptors . There are very few studies on the effect of vitamin D replacement on breast cancer-related survival. There are studies reporting the incidence of fewer breast cancer with vitamin D replacement in contrast to there are studies showing the opposite .Patients achieved pathological complete response (PCR) with neoadjuvant therapy have been shown to have better survival. There are studies showing that they do not affect the PCR ratio related to the level of vitamin D in breast cancer patients receiving neoadjuvant chemotherapy. In one study, it was shown that it increases the response rate when given with bisphosphonate .There is no study evaluating pathological response to neoadjuvant therapy with vitamin D replacement in patients with breast cancer. The aim of the study is to evaluate the relationship between the vitamin D replacement and pathological response in patients undergoing neo-adjuvant therapy according to different molecular subtypes of biopsy-diagnosed breast cancer patients.

Official Title
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The Effect of Vitamin D Replacement Therapy on Pathological Response in Breast Cancer Patients Treated With Neoadjuvant Therapy

Conditions
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Vitamin D Deficiency, Chemotherapy Effect, Pathology

Intervention / Treatment
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* Drug: Vit D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Invasive breast cancer is confirmed by biopsy enough organ function, metabolically normal, eligible for neoadjuvant treatment The patients who were informed about the prerequisites with their consent Exclusion Criteria: having metastatic disease having not operated from breast cancer after neoadjuvant treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: The patients had measured a total of 25 OH vit D3 levels, previously treated with neoadjuvant therapy without replacement treatment with vitamine D3, as a control group, were planned to be compared with 30-50 patient in study groups at baseline and / or at the end of the treatment period. The pathological response rates of both groups were planned to be evaluated according to the molecular subtypes.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: study group<br>The patients measured a total of 25 OH vitamin D3 levels, initial, 3'th month and 6'th month of neoadjuvant therapy with replacement treatment with vitamin D3 at least weekly 50000 IU for eight weeks. | Drug: Vit D<br>* The aim of this study is investigating pathologic response to neoadjuvant therapy if we give replacement therapy with vitamin D3 50.000 IU weekly dosage concurrent with chemotherapy in breast cancer patients.<br>* Other names: cholecalciferol;|
| Other: control group<br>The patients had measured a total of 25 OH vitamin D3 levels, previously treated with neoadjuvant therapy without replacement treatment with vitamin D3. | Drug: Vit D<br>* The aim of this study is investigating pathologic response to neoadjuvant therapy if we give replacement therapy with vitamin D3 50.000 IU weekly dosage concurrent with chemotherapy in breast cancer patients.<br>* Other names: cholecalciferol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathological complete response (PCR) | No residual tumor cells both in axilla and breast | an average 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathological complete response (PCR) relations with vitamin D levels | evaluating PCR in both axilla and breast in terms of levels of total 25 (OH) vitamin D at initial and after replacement vitamin D | an average 24 weeks | 
| pathological complete response (PCR) ratio regarding molecular sub types | evaluating PCR in both axilla and breast in terms of levels of total 25 (OH) vitamin D at initial and after replacement vitamin D according moleculary subtypes | an average 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neoadjuvant treatment, Breast Cancer, Vitamin D3