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

Florence Nightingale Hospital, Istanbul64 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Vitamin D Deficiency Chemotherapy Effect Pathology

Interventions

Vit DDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

İstanbul Florence Nightingale Hospital Breast Health Center

Istanbul, Şişli, Turkey (Türkiye)

Outcomes

Primary Outcomes

pathological complete response (PCR)

No residual tumor cells both in axilla and breast

Time frame: an average 24 weeks

Secondary Outcomes

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

Time frame: 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

Time frame: an average 24 weeks

Data from ClinicalTrials.gov

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