Clinical trial NCT03986268: Vitamin D Can Increase Pathological Response of the Breast Cancer Patients Treated With Neoadjuvant Therapy
Official title: The Effect of Vitamin D Replacement Therapy on Pathological Response in Breast Cancer Patients Treated With Neoadjuvant Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Chemotherapy Effect
Pathology
Keywords: neoadjuvant treatment
Breast Cancer
Vitamin D3
Lead sponsor: Florence Nightingale Hospital, Istanbul
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: pathological complete response (PCR)
timeFrame: an average 24 weeks
Secondary outcomes:
measure: pathological complete response (PCR) relations with vitamin D levels
timeFrame: an average 24 weeks
measure: pathological complete response (PCR) ratio regarding molecular sub types
timeFrame: an average 24 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul Florence Nightingale Hospital Breast Health Center
state: Şişli
Study officials:
affiliation: Gayrettepe FN Hospital
name: Çetin Ordu, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Gayrettepe FN Hospital
name: Fatma Aktepe, Prof
role: STUDY_DIRECTOR
affiliation: İstanbul FN hospital
name: Vahit Özmen, Prof
role: STUDY_CHAIR
References:
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citation: Levi F, Pasche C, Lucchini F, La Vecchia C. Dietary intake of selected micronutrients and breast-cancer risk. Int J Cancer. 2001 Jan 15;91(2):260-3. doi: 10.1002/1097-0215(200002)9999:99993.3.co;2-r.
citation: Viala M, Chiba A, Thezenas S, Delmond L, Lamy PJ, Mott SL, Schroeder MC, Thomas A, Jacot W. Impact of vitamin D on pathological complete response and survival following neoadjuvant chemotherapy for breast cancer: a retrospective study. BMC Cancer. 2018 Jul 30;18(1):770. doi: 10.1186/s12885-018-4686-x.
citation: Zehnder D, Bland R, Williams MC, McNinch RW, Howie AJ, Stewart PM, Hewison M. Extrarenal expression of 25-hydroxyvitamin d(3)-1 alpha-hydroxylase. J Clin Endocrinol Metab. 2001 Feb;86(2):888-94. doi: 10.1210/jcem.86.2.7220.