Clinical trial NCT02571894 - References

Breast Cancer — The Cardio-Oncology Breast Cancer Study

Citation(s)

•   Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al
  The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76.
•   Albini A, Pennesi G, Donatelli F, Cammarota R, De Flora S, Noonan DM
  Cardiotoxicity of anticancer drugs: the need for cardio-oncology and cardio-oncological prevention. J Natl Cancer Inst. 2010 Jan 6;102(1):14-25. doi: 10.1093/jnci/djp440. Epub 2009 Dec 10. Review.
•   Alehagen U, Dahlström U, Rehfeld JF, Goetze JP
  Association of copeptin and N-terminal proBNP concentrations with risk of cardiovascular death in older patients with symptoms of heart failure. JAMA. 2011 May 25;305(20):2088-95. doi: 10.1001/jama.2011.666.
•   Alehagen U, Dahlström U, Rehfeld JF, Goetze JP
  Prognostic assessment of elderly patients with symptoms of heart failure by combining high-sensitivity troponin T and N-terminal pro-B-type natriuretic peptide measurements. Clin Chem. 2010 Nov;56(11):1718-24. doi: 10.1373/clinchem.2009.141341. Epub 2010 Sep 15.
•   Autier P, Boniol M, La Vecchia C, Vatten L, Gavin A, Héry C, Heanue M
  Disparities in breast cancer mortality trends between 30 European countries: retrospective trend analysis of WHO mortality database. BMJ. 2010 Aug 11;341:c3620. doi: 10.1136/bmj.c3620. Erratum in: BMJ. 2010;341:c4480. LaVecchia, Carlo [corrected to La Vecchia, Carlo]..
•   Bozkurt B, Mann DL, Deswal A
  Biomarkers of inflammation in heart failure. Heart Fail Rev. 2010 Jul;15(4):331-41. doi: 10.1007/s10741-009-9140-3. Review.
•   Chisalita SI, Dahlström U, Arnqvist HJ, Alehagen U
  Increased IGF1 levels in relation to heart failure and cardiovascular mortality in an elderly population: impact of ACE inhibitors. Eur J Endocrinol. 2011 Dec;165(6):891-8. doi: 10.1530/EJE-11-0584. Epub 2011 Oct 5.
•   Crone SA, Zhao YY, Fan L, Gu Y, Minamisawa S, Liu Y, Peterson KL, Chen J, Kahn R, Condorelli G, Ross J Jr, Chien KR, Lee KF
  ErbB2 is essential in the prevention of dilated cardiomyopathy. Nat Med. 2002 May;8(5):459-65.
•   Dandel M, Lehmkuhl H, Knosalla C, Suramelashvili N, Hetzer R
  Strain and strain rate imaging by echocardiography - basic concepts and clinical applicability. Curr Cardiol Rev. 2009 May;5(2):133-48. doi: 10.2174/157340309788166642.
•   Dinse GE, Lagakos SW
  Nonparametric estimation of lifetime and disease onset distributions from incomplete observations. Biometrics. 1982 Dec;38(4):921-32.
•   Early Breast Cancer Trialists' Collaborative Group (EBCTCG), Peto R, Davies C, Godwin J, Gray R, Pan HC, Clarke M, Cutter D, Darby S, McGale P, Taylor C, Wang YC, Bergh J, Di Leo A, Albain K, Swain S, Piccart M, Pritchard K
  Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100,000 women in 123 randomised trials. Lancet. 2012 Feb 4;379(9814):432-44. doi: 10.1016/S0140-6736(11)61625-5. Epub 2011 Dec 5.
•   EBCTCG (Early Breast Cancer Trialists' Collaborative Group), McGale P, Taylor C, Correa C, Cutter D, Duane F, Ewertz M, Gray R, Mannu G, Peto R, Whelan T, Wang Y, Wang Z, Darby S
  Effect of radiotherapy after mastectomy and axillary surgery on 10-year recurrence and 20-year breast cancer mortality: meta-analysis of individual patient data for 8135 women in 22 randomised trials. Lancet. 2014 Jun 21;383(9935):2127-35. doi: 10.1016/S0140-6736(14)60488-8. Epub 2014 Mar 19. Erratum in: Lancet. 2014 Nov 22;384(9957):1848.
•   Ewer MS, Swain SM, Cardinale D, Fadol A, Suter TM
  Cardiac dysfunction after cancer treatment. Tex Heart Inst J. 2011;38(3):248-52. Review.
•   Fallah-Rad N, Walker JR, Wassef A, Lytwyn M, Bohonis S, Fang T, Tian G, Kirkpatrick ID, Singal PK, Krahn M, Grenier D, Jassal DS
  The utility of cardiac biomarkers, tissue velocity and strain imaging, and cardiac magnetic resonance imaging in predicting early left ventricular dysfunction in patients with human epidermal growth factor receptor II-positive breast cancer treated with adjuvant trastuzumab therapy. J Am Coll Cardiol. 2011 May 31;57(22):2263-70. doi: 10.1016/j.jacc.2010.11.063.
•   Garrone O, Crosetto N, Lo Nigro C, Catzeddu T, Vivenza D, Monteverde M, Merlano M, Feola M
  Prediction of anthracycline cardiotoxicity after chemotherapy by biomarkers kinetic analysis. Cardiovasc Toxicol. 2012 Jun;12(2):135-42. doi: 10.1007/s12012-011-9149-4.
•   Gilbody S, Richards D, Brealey S, Hewitt C
  Screening for depression in medical settings with the Patient Health Questionnaire (PHQ): a diagnostic meta-analysis. J Gen Intern Med. 2007 Nov;22(11):1596-602. Epub 2007 Sep 14.
•   Goetze JP, Alehagen U, Flyvbjerg A, Rehfeld JF
  Making sense of chromogranin A in heart disease. Lancet Diabetes Endocrinol. 2013 Sep;1(1):7-8. doi: 10.1016/S2213-8587(13)70035-4. Epub 2013 Jun 13. Review.
•   Goldhirsch A, Gelber RD, Piccart-Gebhart MJ, de Azambuja E, Procter M, Suter TM, Jackisch C, Cameron D, Weber HA, Heinzmann D, Dal Lago L, McFadden E, Dowsett M, Untch M, Gianni L, Bell R, Köhne CH, Vindevoghel A, Andersson M, Brunt AM, Otero-Reyes D, Song S, Smith I, Leyland-Jones B, Baselga J; Herceptin Adjuvant (HERA) Trial Study Team
  2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controlled trial. Lancet. 2013 Sep 21;382(9897):1021-8. doi: 10.1016/S0140-6736(13)61094-6. Epub 2013 Jul 18.
•   Harbeck N, Ewer MS, De Laurentiis M, Suter TM, Ewer SM
  Cardiovascular complications of conventional and targeted adjuvant breast cancer therapy. Ann Oncol. 2011 Jun;22(6):1250-8. doi: 10.1093/annonc/mdq543. Epub 2010 Nov 26. Review.
•   Ky B, Putt M, Sawaya H, French B, Januzzi JL Jr, Sebag IA, Plana JC, Cohen V, Banchs J, Carver JR, Wiegers SE, Martin RP, Picard MH, Gerszten RE, Halpern EF, Passeri J, Kuter I, Scherrer-Crosbie M
  Early increases in multiple biomarkers predict subsequent cardiotoxicity in patients with breast cancer treated with doxorubicin, taxanes, and trastuzumab. J Am Coll Cardiol. 2014 Mar 4;63(8):809-16. doi: 10.1016/j.jacc.2013.10.061. Epub 2013 Nov 27. Erratum in: J Am Coll Cardiol. 2016 Mar 22;67(11):1385.
•   Lawley C, Wainwright C, Segelov E, Lynch J, Beith J, McCrohon J
  Pilot study evaluating the role of cardiac magnetic resonance imaging in monitoring adjuvant trastuzumab therapy for breast cancer. Asia Pac J Clin Oncol. 2012 Mar;8(1):95-100. doi: 10.1111/j.1743-7563.2011.01462.x. Epub 2012 Jan 12.
•   Maisel A, Mueller C, Nowak R, Peacock WF, Landsberg JW, Ponikowski P, Mockel M, Hogan C, Wu AH, Richards M, Clopton P, Filippatos GS, Di Somma S, Anand I, Ng L, Daniels LB, Neath SX, Christenson R, Potocki M, McCord J, Terracciano G, Kremastinos D, Hartmann O, von Haehling S, Bergmann A, Morgenthaler NG, Anker SD
  Mid-region pro-hormone markers for diagnosis and prognosis in acute dyspnea: results from the BACH (Biomarkers in Acute Heart Failure) trial. J Am Coll Cardiol. 2010 May 11;55(19):2062-76. doi: 10.1016/j.jacc.2010.02.025.
•   Nilsson G, Holmberg L, Garmo H, Duvernoy O, Sjögren I, Lagerqvist B, Blomqvist C
  Distribution of coronary artery stenosis after radiation for breast cancer. J Clin Oncol. 2012 Feb 1;30(4):380-6. doi: 10.1200/JCO.2011.34.5900. Epub 2011 Dec 27.
•   Oberholzer K, Kunz RP, Dittrich M, Thelen M
  [Anthracycline-induced cardiotoxicity: cardiac MRI after treatment for childhood cancer]. Rofo. 2004 Sep;176(9):1245-50. German.
•   Osoba D, Rodrigues G, Myles J, Zee B, Pater J
  Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol. 1998 Jan;16(1):139-44.
•   Perez EA, Suman VJ, Davidson NE, Sledge GW, Kaufman PA, Hudis CA, Martino S, Gralow JR, Dakhil SR, Ingle JN, Winer EP, Gelmon KA, Gersh BJ, Jaffe AS, Rodeheffer RJ
  Cardiac safety analysis of doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab in the North Central Cancer Treatment Group N9831 adjuvant breast cancer trial. J Clin Oncol. 2008 Mar 10;26(8):1231-8. doi: 10.1200/JCO.2007.13.5467. Epub 2008 Feb 4.
•   Rector TS, Cohn JN
  Assessment of patient outcome with the Minnesota Living with Heart Failure questionnaire: reliability and validity during a randomized, double-blind, placebo-controlled trial of pimobendan. Pimobendan Multicenter Research Group. Am Heart J. 1992 Oct;124(4):1017-25.
•   Rumsfeld JS, Alexander KP, Goff DC Jr, Graham MM, Ho PM, Masoudi FA, Moser DK, Roger VL, Slaughter MS, Smolderen KG, Spertus JA, Sullivan MD, Treat-Jacobson D, Zerwic JJ; American Heart Association Council on Quality of Care and Outcomes Research, Council on Cardiovascular and Stroke Nursing, Council on Epidemiology and Prevention, Council on Peripheral Vascular Disease, and Stroke Council
  Cardiovascular health: the importance of measuring patient-reported health status: a scientific statement from the American Heart Association. Circulation. 2013 Jun 4;127(22):2233-49. doi: 10.1161/CIR.0b013e3182949a2e. Epub 2013 May 6.
•   Sawaya H, Sebag IA, Plana JC, Januzzi JL, Ky B, Tan TC, Cohen V, Banchs J, Carver JR, Wiegers SE, Martin RP, Picard MH, Gerszten RE, Halpern EF, Passeri J, Kuter I, Scherrer-Crosbie M
  Assessment of echocardiography and biomarkers for the extended prediction of cardiotoxicity in patients treated with anthracyclines, taxanes, and trastuzumab. Circ Cardiovasc Imaging. 2012 Sep 1;5(5):596-603. Epub 2012 Jun 28.
•   Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J, Norton L
  Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001 Mar 15;344(11):783-92.
•   Smith DP
  Regression analysis of "current status" life tables on duration of breastfeeding in Sri Lanka. Soc Biol. 1985 Spring-Summer;32(1-2):90-101.
•   Spitzer RL, Kroenke K, Williams JB
  Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44.
•   Sprangers MA, Groenvold M, Arraras JI, Franklin J, te Velde A, Muller M, Franzini L, Williams A, de Haes HC, Hopwood P, Cull A, Aaronson NK
  The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J Clin Oncol. 1996 Oct;14(10):2756-68.
•   Suter TM, Procter M, van Veldhuisen DJ, Muscholl M, Bergh J, Carlomagno C, Perren T, Passalacqua R, Bighin C, Klijn JG, Ageev FT, Hitre E, Groetz J, Iwata H, Knap M, Gnant M, Muehlbauer S, Spence A, Gelber RD, Piccart-Gebhart MJ
  Trastuzumab-associated cardiac adverse effects in the herceptin adjuvant trial. J Clin Oncol. 2007 Sep 1;25(25):3859-65. Epub 2007 Jul 23.
•   Tarantini L, Cioffi G, Gori S, Tuccia F, Boccardi L, Bovelli D, Lestuzzi C, Maurea N, Oliva S, Russo G, Faggiano P; Italian Cardio-Oncologic Network
  Trastuzumab adjuvant chemotherapy and cardiotoxicity in real-world women with breast cancer. J Card Fail. 2012 Feb;18(2):113-9. doi: 10.1016/j.cardfail.2011.10.015. Epub 2011 Dec 3.
•   Verma S, Ewer MS
  Is cardiotoxicity being adequately assessed in current trials of cytotoxic and targeted agents in breast cancer? Ann Oncol. 2011 May;22(5):1011-8. doi: 10.1093/annonc/mdq607. Epub 2010 Nov 22. Review.
•   von Minckwitz G, Blohmer JU, Costa SD, Denkert C, Eidtmann H, Eiermann W, Gerber B, Hanusch C, Hilfrich J, Huober J, Jackisch C, Kaufmann M, Kümmel S, Paepke S, Schneeweiss A, Untch M, Zahm DM, Mehta K, Loibl S
  Response-guided neoadjuvant chemotherapy for breast cancer. J Clin Oncol. 2013 Oct 10;31(29):3623-30. doi: 10.1200/JCO.2012.45.0940. Epub 2013 Sep 3.
•   Yeh ET, Bickford CL
  Cardiovascular complications of cancer therapy: incidence, pathogenesis, diagnosis, and management. J Am Coll Cardiol. 2009 Jun 16;53(24):2231-47. doi: 10.1016/j.jacc.2009.02.050. Review.

Effects of Identifying and Treating Early, Subclinical Cardiotoxicity on the Long-Term Incidence of Clinical Cardiotoxicity in Women With Breast Cancer, A Prospective Randomized Study: The Cardio-Oncology Breast Cancer Study (COBC)

Details for clinical trial NCT02571894