Clinical trial · Interventional
Vitamin D Can Increase Pathological Response of the Breast Cancer Patients Treated With Neoadjuvant Therapy
The Effect of Vitamin D Replacement Therapy on Pathological Response in Breast Cancer Patients Treated With Neoadjuvant Therapy
NCT03986268CI-TRIAL-00074237completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Effect | — | UNRESOLVED | — |
| Pathology | — | UNRESOLVED | — |
| Vitamin D Deficiency | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vit D | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- study group
- description
- 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.
- interventionNames
- Drug: Vit D
- type
- OTHER
- label
- control group
- description
- The patients had measured a total of 25 OH vitamin D3 levels, previously treated with neoadjuvant therapy without replacement treatment with vitamin D3.
- interventionNames
- Drug: Vit D
Primary outcomes (1)
- measure
- pathological complete response (PCR)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (8)
- RESULTClark 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
- RESULTShao 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
- RESULTRossi 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
- RESULTAbbas 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
- RESULTLevi 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
- RESULTViala 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
- RESULTZehnder 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.