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临床试验/NCT03986268
NCT03986268已完成不适用

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

Florence Nightingale Hospital, Istanbul1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2019年5月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
1
主要终点
pathological complete response (PCR)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • having metastatic disease
  • having not operated from breast cancer after neoadjuvant treatment

研究组 & 干预措施

study group

Active Comparator

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.

干预措施: Vit D (Drug)

control group

Other

The patients had measured a total of 25 OH vitamin D3 levels, previously treated with neoadjuvant therapy without replacement treatment with vitamin D3.

干预措施: Vit D (Drug)

结局指标

主要结局

pathological complete response (PCR)

时间窗: an average 24 weeks

No residual tumor cells both in axilla and breast

次要结局

  • pathological complete response (PCR) relations with vitamin D levels(an average 24 weeks)
  • pathological complete response (PCR) ratio regarding molecular sub types(an average 24 weeks)

研究者

发起方
Florence Nightingale Hospital, Istanbul
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cetin Ordu

Assoc. Prof. Çetin Ordu, MD

Florence Nightingale Hospital, Istanbul

研究点 (1)

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