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

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03986268
• Other study ID #: 2019-40016-06
• Status: Completed
• Phase: N/A
• Start date: May 10, 2019
• Est. completion date: December 10, 2020

Study information

• Verified date: February 2024
• Source: Florence Nightingale Hospital, Istanbul
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 10, 2020
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy Effect
• Pathology
• Vitamin D Deficiency

Intervention

Drug:
• Vit D
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.

Locations

Country	Name	City	State
Turkey	Istanbul Florence Nightingale Hospital Breast Health Center	Istanbul	Sisli

Sponsors (1)

Lead Sponsor	Collaborator
Florence Nightingale Hospital, Istanbul

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

Abbas S, Linseisen J, Chang-Claude J. Dietary vitamin D and calcium intake and premenopausal breast cancer risk in a German case-control study. Nutr Cancer. 2007;59(1):54-61. doi: 10.1080/01635580701390223. — View Citation

Clark AS, Chen J, Kapoor S, Friedman C, Mies C, Esserman L, DeMichele A; I-SPY1 Investigators. Pretreatment vitamin D level and response to neoadjuvant chemotherapy in women with breast cancer on the I-SPY trial (CALGB 150007/150015/ACRIN6657). Cancer Med — View 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. — View Citation

Rossi M, McLaughlin JK, Lagiou P, Bosetti C, Talamini R, Lipworth L, Giacosa A, Montella M, Franceschi S, Negri E, La Vecchia C. Vitamin D intake and breast cancer risk: a case-control study in Italy. Ann Oncol. 2009 Feb;20(2):374-8. doi: 10.1093/annonc/m — View Citation

Shao T, Klein P, Grossbard ML. Vitamin D and breast cancer. Oncologist. 2012;17(1):36-45. doi: 10.1634/theoncologist.2011-0278. Epub 2012 Jan 10. — View 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 Ju — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathological complete response (PCR)	No residual tumor cells both in axilla and breast	an average 24 weeks
Secondary	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
Secondary	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