Docetaxel, Doxorubicin and Cyclophosphamide Versus Vinorelbine and Capecitabine in Patients Not Sufficiently / Sufficiently Responding as Preoperative Treatment of Locally Advanced or Operable Primary Breast Cancer

Summary

Primary objective of the study in patients without a sufficient sonographic response (i.e. iNC) to 2 cycles of TAC as preoperative treatment of operable (T\>/= 2cm, N0-2,M0) primary breast cancer: To determine the response rate determined by sonography (iRR = iCR+iPR) of further 4 cycles of docetaxel, doxorubicin and cyclophosphamide (TAC) and of 4 cycles of vinorelbine and capecitabine (NX) (TAC vs. NX) Primary objective of the study in patients with a sufficient sonographic response (i.e. iRR = iPR or iCR) to the first 2 cycles of TAC as preoperative treatment of operable (T\>/=2cm, N0-2,M0) primary breast cancer: To determine the pCR rate of 6 cycles vs. 8 cycles of docetaxel, doxorubicin and cyclophosphamide (TAC x 6 vs. TAC x 8)

Timeline

Start

2002-09

Primary completion

2008-02

Completion

2008-02

Publications

• Results von Minckwitz G, Kummel S, Vogel P, Hanusch C, Eidtmann H, Hilfrich J, Gerber B, Huober J, Costa SD, Jackisch C, Loibl S, Mehta K, Kaufmann M; German Breast Group. Neoadjuvant vinorelbine-capecitabine versus docetaxel-doxorubicin-cyclophosphamide in early nonresponsive breast cancer: phase III randomized GeparTrio trial. J Natl Cancer Inst. 2008 Apr 16;100(8):542-51. doi: 10.1093/jnci/djn085. Epub 2008 Apr 8.
• Results Costa SD, Loibl S, Kaufmann M, Zahm DM, Hilfrich J, Huober J, Eidtmann H, du Bois A, Blohmer JU, Ataseven B, Weiss E, Tesch H, Gerber B, Baumann KH, Thomssen C, Breitbach GP, Ibishi S, Jackisch C, Mehta K, von Minckwitz G. Neoadjuvant chemotherapy shows similar response in patients with inflammatory or locally advanced breast cancer when compared with operable breast cancer: a secondary analysis of the GeparTrio trial data. J Clin Oncol. 2010 Jan 1;28(1):83-91. doi: 10.1200/JCO.2009.23.5101. Epub 2009 Nov 9.
• Results Rody A, Karn T, Gatje R, Ahr A, Solbach C, Kourtis K, Munnes M, Loibl S, Kissler S, Ruckhaberle E, Holtrich U, von Minckwitz G, Kaufmann M. Gene expression profiling of breast cancer patients treated with docetaxel, doxorubicin, and cyclophosphamide within the GEPARTRIO trial: HER-2, but not topoisomerase II alpha and microtubule-associated protein tau, is highly predictive of tumor response. Breast. 2007 Feb;16(1):86-93. doi: 10.1016/j.breast.2006.06.008. Epub 2006 Sep 28.
• Leichsenring J, Vladimirova V, Solbach C, Karn T, Ataseven B, Sinn BV, Barinoff J, Muller V, Blohmer JU, Schem C, Engels K, Marme F, Fisseler-Eckhoff A, Fasching PA, Stickeler E, van Mackelenbergh M, Denkert C, Stenzinger A, Loibl S, Groschel S. EVI1 expression in early-stage breast cancer patients treated with neoadjuvant chemotherapy. BMC Cancer. 2022 Oct 5;22(1):1040. doi: 10.1186/s12885-022-10109-1.
• Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
• Lindner JL, Loibl S, Denkert C, Ataseven B, Fasching PA, Pfitzner BM, Gerber B, Gade S, Darb-Esfahani S, Sinn BV, Huober J, Engels K, Tesch H, Karn T, Pommerenke F, Liedtke C, Untch M, Muller V, Rack B, Schem C, von Minckwitz G. Expression of secreted protein acidic and rich in cysteine (SPARC) in breast cancer and response to neoadjuvant chemotherapy. Ann Oncol. 2015 Jan;26(1):95-100. doi: 10.1093/annonc/mdu487. Epub 2014 Oct 29.
• Darb-Esfahani S, von Minckwitz G, Denkert C, Ataseven B, Hogel B, Mehta K, Kaltenecker G, Rudiger T, Pfitzner B, Kittel K, Fiedler B, Baumann K, Moll R, Dietel M, Eidtmann H, Thomssen C, Loibl S. Gross cystic disease fluid protein 15 (GCDFP-15) expression in breast cancer subtypes. BMC Cancer. 2014 Jul 28;14:546. doi: 10.1186/1471-2407-14-546.
• 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, Kummel 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.
• Sinn BV, von Minckwitz G, Denkert C, Eidtmann H, Darb-Esfahani S, Tesch H, Kronenwett R, Hoffmann G, Belau A, Thommsen C, Holzhausen HJ, Grasshoff ST, Baumann K, Mehta K, Dietel M, Loibl S. Evaluation of Mucin-1 protein and mRNA expression as prognostic and predictive markers after neoadjuvant chemotherapy for breast cancer. Ann Oncol. 2013 Sep;24(9):2316-24. doi: 10.1093/annonc/mdt162. Epub 2013 May 9.
• von Minckwitz G, Untch M, Blohmer JU, Costa SD, Eidtmann H, Fasching PA, Gerber B, Eiermann W, Hilfrich J, Huober J, Jackisch C, Kaufmann M, Konecny GE, Denkert C, Nekljudova V, Mehta K, Loibl S. Definition and impact of pathologic complete response on prognosis after neoadjuvant chemotherapy in various intrinsic breast cancer subtypes. J Clin Oncol. 2012 May 20;30(15):1796-804. doi: 10.1200/JCO.2011.38.8595. Epub 2012 Apr 16.

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