Alpert TE, Kuerer HM, Arthur DW, Lannin DR, Haffty BG Ipsilateral breast tumor recurrence after breast conservation therapy: outcomes of salvage mastectomy vs. salvage breast-conserving surgery and prognostic factors for salvage breast preservation. Int J Radiat Oncol Biol Phys. 2005 Nov 1;63(3):845-51. doi: 10.1016/j.ijrobp.2005.02.035.
Chadha M, Feldman S, Boolbol S, Wang L, Harrison LB The feasibility of a second lumpectomy and breast brachytherapy for localized cancer in a breast previously treated with lumpectomy and radiation therapy for breast cancer. Brachytherapy. 2008 Jan-Mar;7(1):22-8. doi: 10.1016/j.brachy.2007.10.006.
Chen SL, Martinez SR The survival impact of the choice of surgical procedure after ipsilateral breast cancer recurrence. Am J Surg. 2008 Oct;196(4):495-9. doi: 10.1016/j.amjsurg.2008.06.018.
Courdi A, Doyen J, Gal J, Chamorey E Local recurrence after breast cancer affects specific survival differently according to patient age. Oncology. 2010;79(5-6):349-54. doi: 10.1159/000323483. Epub 2011 Mar 23.
Dalberg K, Mattsson A, Sandelin K, Rutqvist LE Outcome of treatment for ipsilateral breast tumor recurrence in early-stage breast cancer. Breast Cancer Res Treat. 1998 May;49(1):69-78. doi: 10.1023/a:1005934513072.
Deutsch M Repeat high-dose external beam irradiation for in-breast tumor recurrence after previous lumpectomy and whole breast irradiation. Int J Radiat Oncol Biol Phys. 2002 Jul 1;53(3):687-91. doi: 10.1016/s0360-3016(02)02785-2.
Doyle T, Schultz DJ, Peters C, Harris E, Solin LJ Long-term results of local recurrence after breast conservation treatment for invasive breast cancer. Int J Radiat Oncol Biol Phys. 2001 Sep 1;51(1):74-80. doi: 10.1016/s0360-3016(01)01625-x.
Hannoun-Levi JM, Ihrai T, Courdi A Local treatment options for ipsilateral breast tumour recurrence. Cancer Treat Rev. 2013 Nov;39(7):737-41. doi: 10.1016/j.ctrv.2013.02.003. Epub 2013 Mar 5.
Herskind C, Griebel J, Kraus-Tiefenbacher U, Wenz F Sphere of equivalence--a novel target volume concept for intraoperative radiotherapy using low-energy X rays. Int J Radiat Oncol Biol Phys. 2008 Dec 1;72(5):1575-81. doi: 10.1016/j.ijrobp.2008.08.009.
Holland R, Veling SH, Mravunac M, Hendriks JH Histologic multifocality of Tis, T1-2 breast carcinomas. Implications for clinical trials of breast-conserving surgery. Cancer. 1985 Sep 1;56(5):979-90. doi: 10.1002/1097-0142(19850901)56:53.0.co;2-n.
Liu Q, Schneider F, Ma L, Wenz F, Herskind C Relative Biologic Effectiveness (RBE) of 50 kV X-rays measured in a phantom for intraoperative tumor-bed irradiation. Int J Radiat Oncol Biol Phys. 2013 Mar 15;85(4):1127-33. doi: 10.1016/j.ijrobp.2012.08.005. Epub 2012 Sep 14.
MacNeill M, Arnott I, Thomas J Fine needle aspiration cytology is a valuable adjunct to axillary ultrasound in the preoperative staging of breast cancer. J Clin Pathol. 2011 Jan;64(1):42-6. doi: 10.1136/jcp.2010.083063. Epub 2010 Nov 19.
Moran MS, Haffty BG Local-regional breast cancer recurrence: prognostic groups based on patterns of failure. Breast J. 2002 Mar-Apr;8(2):81-7. doi: 10.1046/j.1524-4741.2002.08202.x.
Park SH, Kim MJ, Park BW, Moon HJ, Kwak JY, Kim EK Impact of preoperative ultrasonography and fine-needle aspiration of axillary lymph nodes on surgical management of primary breast cancer. Ann Surg Oncol. 2011 Mar;18(3):738-44. doi: 10.1245/s10434-010-1347-y. Epub 2010 Oct 2.
Reitsamer R, Fastner G, Kopp M, Menzel C, Sedlmayer F Intraoperative radiotherapy for early breast cancer. Lancet. 2010 Oct 2;376(9747):1141; author reply 1143-4. doi: 10.1016/S0140-6736(10)61529-2. No abstract available.
Resch A, Fellner C, Mock U, Handl-Zeller L, Biber E, Seitz W, Potter R Locally recurrent breast cancer: pulse dose rate brachytherapy for repeat irradiation following lumpectomy-- a second chance to preserve the breast. Radiology. 2002 Dec;225(3):713-8. doi: 10.1148/radiol.2253011913.
Schmoor C, Sauerbrei W, Bastert G, Schumacher M Role of isolated locoregional recurrence of breast cancer: results of four prospective studies. J Clin Oncol. 2000 Apr;18(8):1696-708. doi: 10.1200/JCO.2000.18.8.1696.
Smith BD, Buchholz TA, Kuerer HM Intraoperative radiotherapy for early breast cancer. Lancet. 2010 Oct 2;376(9747):1141; author reply 1143-4. doi: 10.1016/S0140-6736(10)61530-9. No abstract available.
Smith TE, Lee D, Turner BC, Carter D, Haffty BG True recurrence vs. new primary ipsilateral breast tumor relapse: an analysis of clinical and pathologic differences and their implications in natural history, prognoses, and therapeutic management. Int J Radiat Oncol Biol Phys. 2000 Dec 1;48(5):1281-9. doi: 10.1016/s0360-3016(00)01378-x.
Tanis E, van de Velde CJ, Bartelink H, van de Vijver MJ, Putter H, van der Hage JA Locoregional recurrence after breast-conserving therapy remains an independent prognostic factor even after an event free interval of 10 years in early stage breast cancer. Eur J Cancer. 2012 Aug;48(12):1751-6. doi: 10.1016/j.ejca.2012.02.051. Epub 2012 Mar 23.
Wapnir IL, Aebi S, Gelber S, Anderson SJ, Lang I, Robidoux A, Mamounas EP, Wolmark N Progress on BIG 1-02/IBCSG 27-02/NSABP B-37, a prospective randomized trial evaluating chemotherapy after local therapy for isolated locoregional recurrences of breast cancer. Ann Surg Oncol. 2008 Nov;15(11):3227-31. doi: 10.1245/s10434-008-0129-2. Epub 2008 Sep 11.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
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.