Vitamin D Supplementation in Women With DCIS and/or LCIS

Summary

The purpose of this study is to determine the safety and usefulness of oral Vitamin D supplementation in subjects with in situ carcinoma. More specifically, this study is being done to (1) understand the effect of Vitamin D supplementation on behavior of breast cancer cells and (2) the development of invasive breast cancer disease.

Timeline

Start

2016-08

Primary completion

2019-01

Completion

2019-01

Publications

• Background Bernardes JR Jr, Nonogaki S, Seixas MT, Rodrigues de Lima G, Baracat EC, Gebrim LH. Effect of a half dose of tamoxifen on proliferative activity in normal breast tissue. Int J Gynaecol Obstet. 1999 Oct;67(1):33-8. doi: 10.1016/s0020-7292(99)00092-2.
• Background Chen YY, DeVries S, Anderson J, Lessing J, Swain R, Chin K, Shim V, Esserman LJ, Waldman FM, Hwang ES. Pathologic and biologic response to preoperative endocrine therapy in patients with ER-positive ductal carcinoma in situ. BMC Cancer. 2009 Aug 18;9:285. doi: 10.1186/1471-2407-9-285.
• Background Deeb KK, Trump DL, Johnson CS. Vitamin D signalling pathways in cancer: potential for anticancer therapeutics. Nat Rev Cancer. 2007 Sep;7(9):684-700. doi: 10.1038/nrc2196.
• Background Espina V, Edmiston KH, Liotta LA. Non-enzymatic, serum-free tissue culture of pre-invasive breast lesions for spontaneous generation of mammospheres. J Vis Exp. 2014 Nov 8;(93):e51926. doi: 10.3791/51926.
• Background Espina V, Liotta LA. What is the malignant nature of human ductal carcinoma in situ? Nat Rev Cancer. 2011 Jan;11(1):68-75. doi: 10.1038/nrc2950. Epub 2010 Dec 2.
• Background Espina V, Mariani BD, Gallagher RI, Tran K, Banks S, Wiedemann J, Huryk H, Mueller C, Adamo L, Deng J, Petricoin EF, Pastore L, Zaman S, Menezes G, Mize J, Johal J, Edmiston K, Liotta LA. Malignant precursor cells pre-exist in human breast DCIS and require autophagy for survival. PLoS One. 2010 Apr 20;5(4):e10240. doi: 10.1371/journal.pone.0010240.
• Background Esserman L. Neoadjuvant chemotherapy for primary breast cancer: lessons learned and opportunities to optimize therapy. Ann Surg Oncol. 2004 Jan;11(1 Suppl):3S-8S. doi: 10.1007/BF02524789. No abstract available.
• Background Esserman L, Sepucha K, Ozanne E, Hwang ES. Applying the neoadjuvant paradigm to ductal carcinoma in situ. Ann Surg Oncol. 2004 Jan;11(1 Suppl):28S-36S. doi: 10.1007/BF02524793.
• Background Fisher B, Costantino JP, Wickerham DL, Redmond CK, Kavanah M, Cronin WM, Vogel V, Robidoux A, Dimitrov N, Atkins J, Daly M, Wieand S, Tan-Chiu E, Ford L, Wolmark N. Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst. 1998 Sep 16;90(18):1371-88. doi: 10.1093/jnci/90.18.1371.
• Background Gandini S, Boniol M, Haukka J, Byrnes G, Cox B, Sneyd MJ, Mullie P, Autier P. Meta-analysis of observational studies of serum 25-hydroxyvitamin D levels and colorectal, breast and prostate cancer and colorectal adenoma. Int J Cancer. 2011 Mar 15;128(6):1414-24. doi: 10.1002/ijc.25439.
• Background Gonzalez RJ, Buzdar AU, Fraser Symmans W, Yen TW, Broglio KR, Lucci A, Esteva FJ, Yin G, Kuerer HM. Novel clinical trial designs for treatment of ductal carcinoma in situ of the breast with trastuzumab (herceptin). Breast J. 2007 Jan-Feb;13(1):72-5. doi: 10.1111/j.1524-4741.2006.00366.x.
• Background Hathcock JN, Shao A, Vieth R, Heaney R. Risk assessment for vitamin D. Am J Clin Nutr. 2007 Jan;85(1):6-18. doi: 10.1093/ajcn/85.1.6.
• Background Alipour S, Hadji M, Hosseini L, Omranipour R, Saberi A, Seifollahi A, Bayani L, Shirzad N. Levels of serum 25-hydroxy-vitamin d in benign and malignant breast masses. Asian Pac J Cancer Prev. 2014;15(1):129-32. doi: 10.7314/apjcp.2014.15.1.129.
• Background Hird RB, Chang A, Cimmino V, Diehl K, Sabel M, Kleer C, Helvie M, Schott A, Young J, Hayes D, Newman L. Impact of estrogen receptor expression and other clinicopathologic features on tamoxifen use in ductal carcinoma in situ. Cancer. 2006 May 15;106(10):2113-8. doi: 10.1002/cncr.21873.
• Background Hwang ES, Esserman L. Neoadjuvant hormonal therapy for ductal carcinoma in situ: trial design and preliminary results. Ann Surg Oncol. 2004 Jan;11(1 Suppl):37S-43S. doi: 10.1007/BF02524794.
• Background Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer statistics, 2009. CA Cancer J Clin. 2009 Jul-Aug;59(4):225-49. doi: 10.3322/caac.20006. Epub 2009 May 27.
• Background Jeong Y, Swami S, Krishnan AV, Williams JD, Martin S, Horst RL, Albertelli MA, Feldman BJ, Feldman D, Diehn M. Inhibition of Mouse Breast Tumor-Initiating Cells by Calcitriol and Dietary Vitamin D. Mol Cancer Ther. 2015 Aug;14(8):1951-61. doi: 10.1158/1535-7163.MCT-15-0066. Epub 2015 May 1.
• Background Kaur P, Mishra SK, Mithal A. Vitamin D toxicity resulting from overzealous correction of vitamin D deficiency. Clin Endocrinol (Oxf). 2015 Sep;83(3):327-31. doi: 10.1111/cen.12836. Epub 2015 Jul 14.
• Background Kumar AS, Bhatia V, Henderson IC. Overdiagnosis and overtreatment of breast cancer: rates of ductal carcinoma in situ: a US perspective. Breast Cancer Res. 2005;7(6):271-5. doi: 10.1186/bcr1346. Epub 2005 Nov 11.
• Background Giammanco M, Di Majo D, La Guardia M, Aiello S, Crescimannno M, Flandina C, Tumminello FM, Leto G. Vitamin D in cancer chemoprevention. Pharm Biol. 2015;53(10):1399-434. doi: 10.3109/13880209.2014.988274. Epub 2015 Apr 9.
• Background Lee O, Page K, Ivancic D, Helenowski I, Parini V, Sullivan ME, Margenthaler JA, Chatterton RT Jr, Jovanovic B, Dunn BK, Heckman-Stoddard BM, Foster K, Muzzio M, Shklovskaya J, Skripkauskas S, Kulesza P, Green D, Hansen NM, Bethke KP, Jeruss JS, Bergan R, Khan SA. A randomized phase II presurgical trial of transdermal 4-hydroxytamoxifen gel versus oral tamoxifen in women with ductal carcinoma in situ of the breast. Clin Cancer Res. 2014 Jul 15;20(14):3672-82. doi: 10.1158/1078-0432.CCR-13-3045.
• Background Leonard GD, Swain SM. Ductal carcinoma in situ, complexities and challenges. J Natl Cancer Inst. 2004 Jun 16;96(12):906-20. doi: 10.1093/jnci/djh164.
• Background Li CI, Malone KE, Saltzman BS, Daling JR. Risk of invasive breast carcinoma among women diagnosed with ductal carcinoma in situ and lobular carcinoma in situ, 1988-2001. Cancer. 2006 May 15;106(10):2104-12. doi: 10.1002/cncr.21864.
• Background Li CI, Daling JR, Malone KE. Age-specific incidence rates of in situ breast carcinomas by histologic type, 1980 to 2001. Cancer Epidemiol Biomarkers Prev. 2005 Apr;14(4):1008-11. doi: 10.1158/1055-9965.EPI-04-0849.
• Background Lopes N, Sousa B, Martins D, Gomes M, Vieira D, Veronese LA, Milanezi F, Paredes J, Costa JL, Schmitt F. Alterations in Vitamin D signalling and metabolic pathways in breast cancer progression: a study of VDR, CYP27B1 and CYP24A1 expression in benign and malignant breast lesions. BMC Cancer. 2010 Sep 11;10:483. doi: 10.1186/1471-2407-10-483.
• Background Ma Y, Zhang P, Wang F, Yang J, Liu Z, Qin H. Association between vitamin D and risk of colorectal cancer: a systematic review of prospective studies. J Clin Oncol. 2011 Oct 1;29(28):3775-82. doi: 10.1200/JCO.2011.35.7566. Epub 2011 Aug 29.
• Background Martin-Herranz A, Salinas-Hernandez P. Vitamin D supplementation review and recommendations for women diagnosed with breast or ovary cancer in the context of bone health and cancer prognosis/risk. Crit Rev Oncol Hematol. 2015 Oct;96(1):91-9. doi: 10.1016/j.critrevonc.2015.05.006. Epub 2015 May 19.
• Background Pan H, Cai N, Li M, Liu GH, Izpisua Belmonte JC. Autophagic control of cell 'stemness'. EMBO Mol Med. 2013 Mar;5(3):327-31. doi: 10.1002/emmm.201201999.
• Background Sanders KM, Stuart AL, Williamson EJ, Simpson JA, Kotowicz MA, Young D, Nicholson GC. Annual high-dose oral vitamin D and falls and fractures in older women: a randomized controlled trial. JAMA. 2010 May 12;303(18):1815-22. doi: 10.1001/jama.2010.594.
• Background Schleck ML, Souberbielle JC, Jandrain B, Da Silva S, De Niet S, Vanderbist F, Scheen A, Cavalier E. A Randomized, Double-Blind, Parallel Study to Evaluate the Dose-Response of Three Different Vitamin D Treatment Schemes on the 25-Hydroxyvitamin D Serum Concentration in Patients with Vitamin D Deficiency. Nutrients. 2015 Jul 3;7(7):5413-22. doi: 10.3390/nu7075227.
• Background Schnitt SJ. The transition from ductal carcinoma in situ to invasive breast cancer: the other side of the coin. Breast Cancer Res. 2009;11(1):101. doi: 10.1186/bcr2228. Epub 2009 Feb 27.
• Background Wahler J, So JY, Kim YC, Liu F, Maehr H, Uskokovic M, Suh N. Inhibition of the transition of ductal carcinoma in situ to invasive ductal carcinoma by a Gemini vitamin D analog. Cancer Prev Res (Phila). 2014 Jun;7(6):617-26. doi: 10.1158/1940-6207.CAPR-13-0362. Epub 2014 Apr 1.

Drugs

Indications