NCT02926911 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Erbas B, Provenzano E, Armes J, Gertig D
The natural history of ductal carcinoma in situ of the breast: a review. Breast Cancer Res Treat. 2006 May;97(2):135-44. doi: 10.1007/s10549-005-9101-z. Epub 2005 Dec 1.
Ernster VL, Ballard-Barbash R, Barlow WE, Zheng Y, Weaver DL, Cutter G, Yankaskas BC, Rosenberg R, Carney PA, Kerlikowske K, Taplin SH, Urban N, Geller BM
Detection of ductal carcinoma in situ in women undergoing screening mammography. J Natl Cancer Inst. 2002 Oct 16;94(20):1546-54. doi: 10.1093/jnci/94.20.1546.
Nystrom L, Rutqvist LE, Wall S, Lindgren A, Lindqvist M, Ryden S, Andersson I, Bjurstam N, Fagerberg G, Frisell J, et al
Breast cancer screening with mammography: overview of Swedish randomised trials. Lancet. 1993 Apr 17;341(8851):973-8. doi: 10.1016/0140-6736(93)91067-v. Erratum In: Lancet 1993 Nov 27;342(8883):1372.
Ozanne EM, Shieh Y, Barnes J, Bouzan C, Hwang ES, Esserman LJ
Characterizing the impact of 25 years of DCIS treatment. Breast Cancer Res Treat. 2011 Aug;129(1):165-73. doi: 10.1007/s10549-011-1430-5. Epub 2011 Mar 9.

Comparing an Operation to Monitoring, With or Without Endocrine Therapy (COMET) Trial For Low Risk DCIS: A Phase III Prospective Randomized Trial

Clinical trial NCT02926911 - References