A Phase II Study of Neoadjuvant Trastuzumab+Docetaxel+NPLD+/-Bevacizumab in Her2-pos. Early Breast Cancer (ABCSG 32)
|ClinicalTrials.gov Identifier: NCT01367028|
Recruitment Status : Completed
First Posted : June 6, 2011
Last Update Posted : May 13, 2014
Austrian Breast & Colorectal Cancer Study Group
Information provided by (Responsible Party):
Austrian Breast & Colorectal Cancer Study Group
No Study Results Posted on ClinicalTrials.gov for this Study
|Recruitment Status :||Completed|
|Primary Completion Date :||April 2014|
|Study Completion Date :||April 2014|
Amadori D, Gasparini G, Ardizzoni A, Comella G, Saracchini S, Barone C, Bordonaro R, et al. Phase II study of liposomal doxorubicin (Myocet®), docetaxel and trastuzumab combination as first line treatment of patients with HER-2/neu positive locally advanced or metastatic breast cancer. Cancer Res 2009; 69 (Suppl.): (2).January 15, 3149
Ansell J, Hirsh J, Poller L, Bussey H, Jacobson A, Hylek E. The pharmacology and management of the vitamin K antagonists: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004 Sep;126(3 Suppl):204S-233S. Erratum in: Chest. 2005 Jan;127(1):415-6. Dosage error in article text.
Antón A, Ruiz-Simón A, Plazaola A, Calvo L, Segui M. A, Santabella A, Muňoz M, et al. Phase II study of a 3-weekly liposome-encapsulated doxorubicin/docetaxel/pegfilgrastim in combination with weekly trastuzumab as primary treatment in HER2 positive (HER+) early stage cancer patients (II-IIIa). GEICAM 2003-03 study. Cancer Res 2009; 69 (Suppl.): (2).January 15, 5117
Avastin® (Bevacizumab) Investigator Brochure, Fifteenth Version: November 2007
Balazsovits JA, Mayer LD, Bally MB, Cullis PR, McDonell M, Ginsberg RS, Falk RE. Analysis of the effect of liposome encapsulation on the vesicant properties, acute and cardiac toxicities, and antitumor efficacy of doxorubicin. Cancer Chemother Pharmacol. 1989;23(2):81-6.
Bartsch R, Wenzel C, Hussian D, Pluschnig U, Sevelda U, Koestler W, Altorjai G, Locker GJ, Mader R, Zielinski CC, Steger GG. Analysis of trastuzumab and chemotherapy in advanced breast cancer after the failure of at least one earlier combination: an observational study. BMC Cancer. 2006 Mar 15;6:63.
Bartsch R, Wenzel C, Altorjai G, Pluschnig U, Rudas M, Mader RM, Gnant M, Zielinski CC, Steger GG. Capecitabine and trastuzumab in heavily pretreated metastatic breast cancer. J Clin Oncol. 2007 Sep 1;25(25):3853-8. Epub 2007 Aug 6.
Barton GJ, Ponting CP, Spraggon G, Finnis C, Sleep D. Human platelet-derived endothelial cell growth factor is homologous to Escherichia coli thymidine phosphorylase. Protein Sci. 1992 May;1(5):688-90.
Batist G, Ramakrishnan G, Rao CS, Chandrasekharan A, Gutheil J, Guthrie T, Shah P, Khojasteh A, Nair MK, Hoelzer K, Tkaczuk K, Park YC, Lee LW. Reduced cardiotoxicity and preserved antitumor efficacy of liposome-encapsulated doxorubicin and cyclophosphamide compared with conventional doxorubicin and cyclophosphamide in a randomized, multicenter trial of metastatic breast cancer. J Clin Oncol. 2001 Mar 1;19(5):1444-54.
Bertolini F, Paul S, Mancuso P, Monestiroli S, Gobbi A, Shaked Y, Kerbel RS. Maximum tolerable dose and low-dose metronomic chemotherapy have opposite effects on the mobilization and viability of circulating endothelial progenitor cells. Cancer Res. 2003 Aug 1;63(15):4342-6.
Blum JL, Dieras V, Lo Russo PM, Horton J, Rutman O, Buzdar A, Osterwalder B. Multicenter, Phase II study of capecitabine in taxane-pretreated metastatic breast carcinoma patients. Cancer. 2001 Oct 1;92(7):1759-68.
Blum JL, Jones SE, Buzdar AU, LoRusso PM, Kuter I, Vogel C, Osterwalder B, Burger HU, Brown CS, Griffin T. Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. J Clin Oncol. 1999 Feb;17(2):485-93.
Borgström P, Gold DP, Hillan KJ, Ferrara N. Importance of VEGF for breast cancer angiogenesis in vivo: implications from intravital microscopy of combination treatments with an anti-VEGF neutralizing monoclonal antibody and doxorubicin. Anticancer Res. 1999 Sep-Oct;19(5B):4203-14.
Budman DR, Meropol NJ, Reigner B, Creaven PJ, Lichtman SM, Berghorn E, Behr J, Gordon RJ, Osterwalder B, Griffin T. Preliminary studies of a novel oral fluoropyrimidine carbamate: capecitabine. J Clin Oncol. 1998 May;16(5):1795-802.
Phase II trial of the anti-VEGF antibody bevacizumab in combination with vinorelbine for refractory advanced breast cancer [abstract 446]. Breast Cancer Res Treat 2002;76:S115
Browder T, Butterfield CE, Kräling BM, Shi B, Marshall B, O'Reilly MS, Folkman J. Antiangiogenic scheduling of chemotherapy improves efficacy against experimental drug-resistant cancer. Cancer Res. 2000 Apr 1;60(7):1878-86.
Chan S, Friedrichs K, Noel D, Pintér T, Van Belle S, Vorobiof D, Duarte R, Gil Gil M, Bodrogi I, Murray E, Yelle L, von Minckwitz G, Korec S, Simmonds P, Buzzi F, González Mancha R, Richardson G, Walpole E, Ronzoni M, Murawsky M, Alakl M, Riva A, Crown J; 303 Study Group. Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer. J Clin Oncol. 1999 Aug;17(8):2341-54.
Epstein M, Ayala R, Tchekmedyian N et al. HER-2/neu-overexpressing human breast cancer xenografts exhibit increased angiogenic potential mediated by vascular endothelial growth factor (VEGF). Breast Cancer Res. Treat. 2002; 76: S143
Extra JM, Antoine EC, Vincent-Salomon A et al. Favourable effect of trastuzumab (Herceptin®) treatment in metastatic breast cancer patients: results from the French Hermine cohort study. Poster presentation, 2006 SABCS, San Antonio, Texas
Hambleton J, Novotny F, Hurwitz H et al. Bevacizumab (Avastin) does not increase the incidence of bleeding in patients with metastatic colorectal cancer receiving simultaneous anticoagulation. ASCO New Orleans 2004,Abstract 3528
Herceptin® (Trastuzumab) Investigator Brochure, Version: October 5, 2007
Jackisch C, Eustermann H, Schoenegg W et al. Routine clinical usage of trastuzumab (Herceptin®) in advanced breast cancer in Germany from 2001 to 2006. 2007; Poster Presentation, SABCS
Jain RK. Antiangiogenic therapy for cancer: current and emerging concepts. Oncology (Williston Park). 2005 Apr;19(4 Suppl 3):7-16. Review.
Kabbinavar FF, Wong JT, Ayala RE et al. The effect of antibody to vascular endothelia growth factor and cisplatin on the growth of lung tumors in nude mice [abstract]. Proc Am Assoc Cancer Res 1995; 36:488
Ménard S (on behalf of the Demetra Group). Observational Demetra study: Survival of metastatic breast carcinoma patients after treatment with trastuzumab. J Clin Oncol 26: 2008 (May 20 suppl; abstr 1062)
Miles D, Chan A, Romieu G et al. Randomized, double-blind, placebo-controlled, phase III study of bevacizumab with docetaxel or docetaxel with placebo as first-line therapy for patients with locally recurrent or metastatic breast cancer (mBC): AVADO. J Clin Oncol 26:2008 (May 20 Suppl; abstr LBA1011). Presented at the 2008 ASCO Annual Meeting
Myers CE. Anthracyclines. In: Chabner B, ed. Pharmacologic principles of cancer treatment. Philadelphia: Saunders 1982: xii, 457 p
O'Shaughnessy J, Blackwell KL, Burstein H et al. A randomized study of lapatinib alone or in combination with trastuzumab in heavily pretreated HER2+ metastatic breast cancer progressing on trastuzumab therapy. J Clin Oncol 26: 2008 (May 20 suppl; abstr 1015)
Pegram M, Yeon C, Ku NC et al. Phase I combined biological therapy of breast cancer using two humanized monoclonal antibodies directed against HER2 protooncogene and vascular endothelial growth factor (VEGF). 2004; SABCS
Pegram M, Chan D, Dichmann RA et al., Phase II combined biological therapy targeting the HER2 proto-oncogene and the vascular endothelial growth factor using trastuzumab (T) and bevacizumab (B) as first-line treatment of HER2-amplified breast cancer. 2006; Poster Presentation, SABCS
Potchoiba MJ, West M, Smolarek TA, Macaione G, Santacroce E, Lundeen GR. Tissue distribution of doxorubicin in the free and liposomal forms in male Beagles. Proc Am Assoc Cancer Res 1996; 37:A2675
Rugo H, Dickler MN, Scott JH et al. Change in circulating endothelial cells (CEC) and tumor cells (CTC) in patients (pts) receiving bevacizumab and erlotinib for metastatic breast cancer (MBC) predicts stable disease at first evaluation [abstract 525]. J Clin Oncol 2005;23:10s
Schippinger W, Lileg B, Ploner F, Weitzer W, Bauernhofer TH, Samonigg H. Neoadjuvant chemotherapy with non-pegylated liposomal doxorubicin, docetaxel and trastuzumab in HER-2/neu overexpressing breast cancer. Ann Oncol 2007; 18 (Suppl 9): 28p
Shweiki D, Itin A, Soffer D et al. Vascular endothelial growth factor induced by hypoxia may mediate hypoxia-initiated angiogenesis. Nature (Lond.) 1992; 359: 843-845.Slamon DJ, Clark GM, Wong SG et al. Human breast cancer: correlation of relapse and survival with amplification of the Her-2/neu oncogene. Science 1987; 235:177-182
Slamon DJ, Godolphin W, Jones LA, Holt JA, Wong SG, Keith DE, Levin WJ, Stuart SG, Udove J, Ullrich A, et al. Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science. 1989 May 12;244(4905):707-12.
Sledge GW, Miller KD, Moisa CF et al. Safety and efficacy of capecitabine plus bevacizumab as first-line treatment in metastatic breast cancer J Clin Oncol 2007; 25: 35s ASCO abstract 1013
Traina TA, Dickler MN, Caravelli JF et al. A phase II trial of letrozole in combination with bevacizumab, an anti-VEGF antibody, in patients with hormone receptor-positive metastatic breast cancer [abstract 2030]. Breast Cancer Res Treat 2005;94:S93
Tycznski JE, Bray F and. Parkin DM. Breast cancer in Europe. International Agency for Research on Cancer: European Network of Cancer Registries Cancer Fact Sheet 2002; 2
Venturini M, Bighin C, Puglisi F, Contu A, Aitini E, Colucci G, et al. A multicenter phase II study of non-pegylated liposomal doxorubicin (Myocet®) in combination with trastuzumab and docetaxel as first line therapy in metastatic breast cancer. Cancer Res 2009; 69 (Suppl.): (2). January 15, 3156
Von Minckwitz G, Zielinski C, Maarteense E et al. Capecitabine vs. capecitabine + trastuzumab in patients with HER2-positive metastatic breast cancer progressing during trastuzumab treatment: The TBP phase III study (GBG 26/BIG 3-05). J Clin Oncol 26: 2008 (May 20 suppl; abstr 1025)
Yardley DA, Hart L, Badarinath S et al. Preliminary results of a multicenter study of bevacizumab with 3 docetaxel-based adjuvant breast cancer regimens. San Antonio Breast Cancer Symposium, 2007, Poster Presentation