drugset / Trial / NCT03986268
Vitamin D Can Increase Pathological Response of the Breast Cancer Patients Treated With Neoadjuvant Therapy
Non-randomizedFactorialOpen-labelTreatment
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.
Timeline
- Start
- 2019-05-10
- Primary completion
- 2020-12-10
- Completion
- 2020-12-10
Outcome
Met primary endpoint
paper In the multivariate analysis, factors significantly affecting pCR were vitamin D intake (OR: 2.33, 95% CI 1.20-4.53; p = 0.013). PMID 40229998 ↗
paper Vitamin D supplementation during NST has a significant effect on pCR in breast cancer patients. PMID 40229998 ↗
Publications
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vit D | Unknown | 50000 iu | Oral |