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

NCT ID: NCT03986268

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-10
• Study Completion Date: 2020-12-10

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.

Conditions

Vitamin D Deficiency; Chemotherapy Effect; Pathology

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

study group

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.

Group Type: ACTIVE_COMPARATOR

Vit D

Intervention Type: 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.

control group

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

Group Type: OTHER

Vit D

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Vitamin D3; cholecalciferol

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Florence Nightingale Hospital, Istanbul

OTHER

Sponsor Role: lead

Responsible Party

Cetin Ordu

Assoc. Prof. Çetin Ordu, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Çetin Ordu, Assoc. Prof

Role: PRINCIPAL_INVESTIGATOR

Gayrettepe FN Hospital

Fatma Aktepe, Prof

Role: STUDY_DIRECTOR

Gayrettepe FN Hospital

Vahit Özmen, Prof

Role: STUDY_CHAIR

İstanbul FN hospital

Locations

İstanbul Florence Nightingale Hospital Breast Health Center

Istanbul, Şişli, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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. 2014 Jun;3(3):693-701. doi: 10.1002/cam4.235. Epub 2014 Apr 9.

Reference Type: RESULT

PMID: 24719175 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22234628 (View on PubMed)

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/mdn550. Epub 2008 Aug 18.

Reference Type: RESULT

PMID: 18711029 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17927502 (View on PubMed)

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.

Reference Type: RESULT

PMID: 11146455 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30060745 (View on PubMed)

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.

Reference Type: RESULT

PMID: 11158062 (View on PubMed)

Ozkurt E, Ordu C, Ozmen T, Ilgun AS, Soybir G, Celebi F, Koc E, Ak N, Alco G, Kurt S, Agacayak F, Yavuz E, Tuzlali S, Ozmen V. Vitamin D Supplementation During Neoadjuvant Chemotherapy for Breast Cancer Improves Pathological Complete Response: A Prospective Randomized Clinical Trial. World J Surg. 2025 Jun;49(6):1396-1405. doi: 10.1002/wjs.12587. Epub 2025 Apr 14.

Reference Type: DERIVED

PMID: 40229998 (View on PubMed)

Other Identifiers

2019-40016-06

Identifier Type: -

Identifier Source: org_study_id