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Completed

NCT Number: NCT03986268

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

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Breast Diseases Breast Neoplasms Chemotherapy Effect Deficiency Diseases Malnutrition Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Pathology Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

İstanbul Florence Nightingale Hospital Breast Health Center

Istanbul, Şişli, 34450, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vit D

Drug

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.

Other names: Vitamin D3, cholecalciferol

Primary outcomes

  1. pathological complete response (PCR)

    Time frame: an average 24 weeks

    No residual tumor cells both in axilla and breast

Secondary outcomes

  1. pathological complete response (PCR) relations with vitamin D levels

    Time frame: an average 24 weeks

    evaluating PCR in both axilla and breast in terms of levels of total 25 (OH) vitamin D at initial and after replacement vitamin D

  2. pathological complete response (PCR) ratio regarding molecular sub types

    Time frame: an average 24 weeks

    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

Sponsors and collaborators

Lead sponsor

Florence Nightingale Hospital, Istanbul

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 14, 2019
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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