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

NCT03986268 | Completed

• 1 other identifier: 2019-40016-06
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency; Chemotherapy Effect; Pathology

Keywords

neoadjuvant treatment; Breast Cancer; Vitamin D3

Outcome Measures

Primary Outcomes (1)

• pathological complete response (PCR)

  No residual tumor cells both in axilla and breast

  an average 24 weeks

Secondary Outcomes (2)

• 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

Study Arms (2)

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.

Drug: Vit D

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.

Drug: Vit D

Interventions

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.

Also known as: Vitamin D3, cholecalciferol

control group; study group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Florence Nightingale Hospital, Istanbul: lead

Study Sites (1)

İstanbul Florence Nightingale Hospital Breast Health Center

Istanbul, Şişli, 34450, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 24719175 RESULT

• 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.

  PMID: 22234628 RESULT

• 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.

  PMID: 18711029 RESULT

• 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.

  PMID: 17927502 RESULT

• 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.

  PMID: 11146455 RESULT

• 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.

  PMID: 30060745 RESULT

• 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.

  PMID: 11158062 RESULT

• 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.

  PMID: 40229998 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency; Breast Neoplasms

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Çetin Ordu, Assoc. Prof

  Gayrettepe FN Hospital

  PRINCIPAL INVESTIGATOR

• Fatma Aktepe, Prof

  Gayrettepe FN Hospital

  STUDY DIRECTOR

• Vahit Özmen, Prof

  İstanbul FN hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Çetin Ordu, MD

Model Details: 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.

Study Record Dates

• First Submitted: May 26, 2019
• First Posted: June 14, 2019
• Study Start: May 10, 2019
• Primary Completion: December 10, 2020
• Study Completion: December 10, 2020
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)