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General Session Abstracts

Abstract S5-05: Postneoadjuvant treatment with zoledronate in patients with tumor residuals after anthracyclines-taxane-based chemotherapy for primary breast cancer – The phase III NATAN study (GBG 36/ABCSG XX)

G von Minckwitz, M Rezai, H Eidtmann, H Tesch, J Huober, B Gerber, DM Zahn, S Costa, M Gnant, JU Blohmer, C Denkert, C Hanusch, C Jackisch, S Kümmel, PA Fasching, A Schneeweiss, S Paepke, M Untch, V Nekljudova, K Mehta and S Loibl
G von Minckwitz
German Breast Group, Neu-Isenburg, Germany; Luisenkrankenhaus Düsseldorf, Germany; Universitäts Frauenklinik Kiel, Germany; Onkologische Gemeinschaftspraxis, Frankfurt, Germany; Frauenklinik Ulm, Germany; Universitäts-Frauenklinik Rostock, Germany; SRH Wald Klinikum Gera, Germany; Universitätsklinikum Magdeburg, Germany; Medical University of Vienna, Austria; Sankt Gertrauden Krankenhaus, Berlin, Germany; Charité University, Berlin, Germany; Rotkruezklinikum München, Germany; Klinikum Offenbach, Germany; Kliniken Essen Mitte, Germany; University Erlangen, Germany; University Heidelberg; Klinikum Rechts der Isar der TU München, Germany; Helios Kliniken Berlin, Germany; Frauenklinik Frankfurt, Germany
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M Rezai
German Breast Group, Neu-Isenburg, Germany; Luisenkrankenhaus Düsseldorf, Germany; Universitäts Frauenklinik Kiel, Germany; Onkologische Gemeinschaftspraxis, Frankfurt, Germany; Frauenklinik Ulm, Germany; Universitäts-Frauenklinik Rostock, Germany; SRH Wald Klinikum Gera, Germany; Universitätsklinikum Magdeburg, Germany; Medical University of Vienna, Austria; Sankt Gertrauden Krankenhaus, Berlin, Germany; Charité University, Berlin, Germany; Rotkruezklinikum München, Germany; Klinikum Offenbach, Germany; Kliniken Essen Mitte, Germany; University Erlangen, Germany; University Heidelberg; Klinikum Rechts der Isar der TU München, Germany; Helios Kliniken Berlin, Germany; Frauenklinik Frankfurt, Germany
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H Eidtmann
German Breast Group, Neu-Isenburg, Germany; Luisenkrankenhaus Düsseldorf, Germany; Universitäts Frauenklinik Kiel, Germany; Onkologische Gemeinschaftspraxis, Frankfurt, Germany; Frauenklinik Ulm, Germany; Universitäts-Frauenklinik Rostock, Germany; SRH Wald Klinikum Gera, Germany; Universitätsklinikum Magdeburg, Germany; Medical University of Vienna, Austria; Sankt Gertrauden Krankenhaus, Berlin, Germany; Charité University, Berlin, Germany; Rotkruezklinikum München, Germany; Klinikum Offenbach, Germany; Kliniken Essen Mitte, Germany; University Erlangen, Germany; University Heidelberg; Klinikum Rechts der Isar der TU München, Germany; Helios Kliniken Berlin, Germany; Frauenklinik Frankfurt, Germany
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H Tesch
German Breast Group, Neu-Isenburg, Germany; Luisenkrankenhaus Düsseldorf, Germany; Universitäts Frauenklinik Kiel, Germany; Onkologische Gemeinschaftspraxis, Frankfurt, Germany; Frauenklinik Ulm, Germany; Universitäts-Frauenklinik Rostock, Germany; SRH Wald Klinikum Gera, Germany; Universitätsklinikum Magdeburg, Germany; Medical University of Vienna, Austria; Sankt Gertrauden Krankenhaus, Berlin, Germany; Charité University, Berlin, Germany; Rotkruezklinikum München, Germany; Klinikum Offenbach, Germany; Kliniken Essen Mitte, Germany; University Erlangen, Germany; University Heidelberg; Klinikum Rechts der Isar der TU München, Germany; Helios Kliniken Berlin, Germany; Frauenklinik Frankfurt, Germany
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J Huober
German Breast Group, Neu-Isenburg, Germany; Luisenkrankenhaus Düsseldorf, Germany; Universitäts Frauenklinik Kiel, Germany; Onkologische Gemeinschaftspraxis, Frankfurt, Germany; Frauenklinik Ulm, Germany; Universitäts-Frauenklinik Rostock, Germany; SRH Wald Klinikum Gera, Germany; Universitätsklinikum Magdeburg, Germany; Medical University of Vienna, Austria; Sankt Gertrauden Krankenhaus, Berlin, Germany; Charité University, Berlin, Germany; Rotkruezklinikum München, Germany; Klinikum Offenbach, Germany; Kliniken Essen Mitte, Germany; University Erlangen, Germany; University Heidelberg; Klinikum Rechts der Isar der TU München, Germany; Helios Kliniken Berlin, Germany; Frauenklinik Frankfurt, Germany
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B Gerber
German Breast Group, Neu-Isenburg, Germany; Luisenkrankenhaus Düsseldorf, Germany; Universitäts Frauenklinik Kiel, Germany; Onkologische Gemeinschaftspraxis, Frankfurt, Germany; Frauenklinik Ulm, Germany; Universitäts-Frauenklinik Rostock, Germany; SRH Wald Klinikum Gera, Germany; Universitätsklinikum Magdeburg, Germany; Medical University of Vienna, Austria; Sankt Gertrauden Krankenhaus, Berlin, Germany; Charité University, Berlin, Germany; Rotkruezklinikum München, Germany; Klinikum Offenbach, Germany; Kliniken Essen Mitte, Germany; University Erlangen, Germany; University Heidelberg; Klinikum Rechts der Isar der TU München, Germany; Helios Kliniken Berlin, Germany; Frauenklinik Frankfurt, Germany
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DM Zahn
German Breast Group, Neu-Isenburg, Germany; Luisenkrankenhaus Düsseldorf, Germany; Universitäts Frauenklinik Kiel, Germany; Onkologische Gemeinschaftspraxis, Frankfurt, Germany; Frauenklinik Ulm, Germany; Universitäts-Frauenklinik Rostock, Germany; SRH Wald Klinikum Gera, Germany; Universitätsklinikum Magdeburg, Germany; Medical University of Vienna, Austria; Sankt Gertrauden Krankenhaus, Berlin, Germany; Charité University, Berlin, Germany; Rotkruezklinikum München, Germany; Klinikum Offenbach, Germany; Kliniken Essen Mitte, Germany; University Erlangen, Germany; University Heidelberg; Klinikum Rechts der Isar der TU München, Germany; Helios Kliniken Berlin, Germany; Frauenklinik Frankfurt, Germany
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S Costa
German Breast Group, Neu-Isenburg, Germany; Luisenkrankenhaus Düsseldorf, Germany; Universitäts Frauenklinik Kiel, Germany; Onkologische Gemeinschaftspraxis, Frankfurt, Germany; Frauenklinik Ulm, Germany; Universitäts-Frauenklinik Rostock, Germany; SRH Wald Klinikum Gera, Germany; Universitätsklinikum Magdeburg, Germany; Medical University of Vienna, Austria; Sankt Gertrauden Krankenhaus, Berlin, Germany; Charité University, Berlin, Germany; Rotkruezklinikum München, Germany; Klinikum Offenbach, Germany; Kliniken Essen Mitte, Germany; University Erlangen, Germany; University Heidelberg; Klinikum Rechts der Isar der TU München, Germany; Helios Kliniken Berlin, Germany; Frauenklinik Frankfurt, Germany
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M Gnant
German Breast Group, Neu-Isenburg, Germany; Luisenkrankenhaus Düsseldorf, Germany; Universitäts Frauenklinik Kiel, Germany; Onkologische Gemeinschaftspraxis, Frankfurt, Germany; Frauenklinik Ulm, Germany; Universitäts-Frauenklinik Rostock, Germany; SRH Wald Klinikum Gera, Germany; Universitätsklinikum Magdeburg, Germany; Medical University of Vienna, Austria; Sankt Gertrauden Krankenhaus, Berlin, Germany; Charité University, Berlin, Germany; Rotkruezklinikum München, Germany; Klinikum Offenbach, Germany; Kliniken Essen Mitte, Germany; University Erlangen, Germany; University Heidelberg; Klinikum Rechts der Isar der TU München, Germany; Helios Kliniken Berlin, Germany; Frauenklinik Frankfurt, Germany
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JU Blohmer
German Breast Group, Neu-Isenburg, Germany; Luisenkrankenhaus Düsseldorf, Germany; Universitäts Frauenklinik Kiel, Germany; Onkologische Gemeinschaftspraxis, Frankfurt, Germany; Frauenklinik Ulm, Germany; Universitäts-Frauenklinik Rostock, Germany; SRH Wald Klinikum Gera, Germany; Universitätsklinikum Magdeburg, Germany; Medical University of Vienna, Austria; Sankt Gertrauden Krankenhaus, Berlin, Germany; Charité University, Berlin, Germany; Rotkruezklinikum München, Germany; Klinikum Offenbach, Germany; Kliniken Essen Mitte, Germany; University Erlangen, Germany; University Heidelberg; Klinikum Rechts der Isar der TU München, Germany; Helios Kliniken Berlin, Germany; Frauenklinik Frankfurt, Germany
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C Denkert
German Breast Group, Neu-Isenburg, Germany; Luisenkrankenhaus Düsseldorf, Germany; Universitäts Frauenklinik Kiel, Germany; Onkologische Gemeinschaftspraxis, Frankfurt, Germany; Frauenklinik Ulm, Germany; Universitäts-Frauenklinik Rostock, Germany; SRH Wald Klinikum Gera, Germany; Universitätsklinikum Magdeburg, Germany; Medical University of Vienna, Austria; Sankt Gertrauden Krankenhaus, Berlin, Germany; Charité University, Berlin, Germany; Rotkruezklinikum München, Germany; Klinikum Offenbach, Germany; Kliniken Essen Mitte, Germany; University Erlangen, Germany; University Heidelberg; Klinikum Rechts der Isar der TU München, Germany; Helios Kliniken Berlin, Germany; Frauenklinik Frankfurt, Germany
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C Hanusch
German Breast Group, Neu-Isenburg, Germany; Luisenkrankenhaus Düsseldorf, Germany; Universitäts Frauenklinik Kiel, Germany; Onkologische Gemeinschaftspraxis, Frankfurt, Germany; Frauenklinik Ulm, Germany; Universitäts-Frauenklinik Rostock, Germany; SRH Wald Klinikum Gera, Germany; Universitätsklinikum Magdeburg, Germany; Medical University of Vienna, Austria; Sankt Gertrauden Krankenhaus, Berlin, Germany; Charité University, Berlin, Germany; Rotkruezklinikum München, Germany; Klinikum Offenbach, Germany; Kliniken Essen Mitte, Germany; University Erlangen, Germany; University Heidelberg; Klinikum Rechts der Isar der TU München, Germany; Helios Kliniken Berlin, Germany; Frauenklinik Frankfurt, Germany
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C Jackisch
German Breast Group, Neu-Isenburg, Germany; Luisenkrankenhaus Düsseldorf, Germany; Universitäts Frauenklinik Kiel, Germany; Onkologische Gemeinschaftspraxis, Frankfurt, Germany; Frauenklinik Ulm, Germany; Universitäts-Frauenklinik Rostock, Germany; SRH Wald Klinikum Gera, Germany; Universitätsklinikum Magdeburg, Germany; Medical University of Vienna, Austria; Sankt Gertrauden Krankenhaus, Berlin, Germany; Charité University, Berlin, Germany; Rotkruezklinikum München, Germany; Klinikum Offenbach, Germany; Kliniken Essen Mitte, Germany; University Erlangen, Germany; University Heidelberg; Klinikum Rechts der Isar der TU München, Germany; Helios Kliniken Berlin, Germany; Frauenklinik Frankfurt, Germany
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S Kümmel
German Breast Group, Neu-Isenburg, Germany; Luisenkrankenhaus Düsseldorf, Germany; Universitäts Frauenklinik Kiel, Germany; Onkologische Gemeinschaftspraxis, Frankfurt, Germany; Frauenklinik Ulm, Germany; Universitäts-Frauenklinik Rostock, Germany; SRH Wald Klinikum Gera, Germany; Universitätsklinikum Magdeburg, Germany; Medical University of Vienna, Austria; Sankt Gertrauden Krankenhaus, Berlin, Germany; Charité University, Berlin, Germany; Rotkruezklinikum München, Germany; Klinikum Offenbach, Germany; Kliniken Essen Mitte, Germany; University Erlangen, Germany; University Heidelberg; Klinikum Rechts der Isar der TU München, Germany; Helios Kliniken Berlin, Germany; Frauenklinik Frankfurt, Germany
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PA Fasching
German Breast Group, Neu-Isenburg, Germany; Luisenkrankenhaus Düsseldorf, Germany; Universitäts Frauenklinik Kiel, Germany; Onkologische Gemeinschaftspraxis, Frankfurt, Germany; Frauenklinik Ulm, Germany; Universitäts-Frauenklinik Rostock, Germany; SRH Wald Klinikum Gera, Germany; Universitätsklinikum Magdeburg, Germany; Medical University of Vienna, Austria; Sankt Gertrauden Krankenhaus, Berlin, Germany; Charité University, Berlin, Germany; Rotkruezklinikum München, Germany; Klinikum Offenbach, Germany; Kliniken Essen Mitte, Germany; University Erlangen, Germany; University Heidelberg; Klinikum Rechts der Isar der TU München, Germany; Helios Kliniken Berlin, Germany; Frauenklinik Frankfurt, Germany
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A Schneeweiss
German Breast Group, Neu-Isenburg, Germany; Luisenkrankenhaus Düsseldorf, Germany; Universitäts Frauenklinik Kiel, Germany; Onkologische Gemeinschaftspraxis, Frankfurt, Germany; Frauenklinik Ulm, Germany; Universitäts-Frauenklinik Rostock, Germany; SRH Wald Klinikum Gera, Germany; Universitätsklinikum Magdeburg, Germany; Medical University of Vienna, Austria; Sankt Gertrauden Krankenhaus, Berlin, Germany; Charité University, Berlin, Germany; Rotkruezklinikum München, Germany; Klinikum Offenbach, Germany; Kliniken Essen Mitte, Germany; University Erlangen, Germany; University Heidelberg; Klinikum Rechts der Isar der TU München, Germany; Helios Kliniken Berlin, Germany; Frauenklinik Frankfurt, Germany
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S Paepke
German Breast Group, Neu-Isenburg, Germany; Luisenkrankenhaus Düsseldorf, Germany; Universitäts Frauenklinik Kiel, Germany; Onkologische Gemeinschaftspraxis, Frankfurt, Germany; Frauenklinik Ulm, Germany; Universitäts-Frauenklinik Rostock, Germany; SRH Wald Klinikum Gera, Germany; Universitätsklinikum Magdeburg, Germany; Medical University of Vienna, Austria; Sankt Gertrauden Krankenhaus, Berlin, Germany; Charité University, Berlin, Germany; Rotkruezklinikum München, Germany; Klinikum Offenbach, Germany; Kliniken Essen Mitte, Germany; University Erlangen, Germany; University Heidelberg; Klinikum Rechts der Isar der TU München, Germany; Helios Kliniken Berlin, Germany; Frauenklinik Frankfurt, Germany
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M Untch
German Breast Group, Neu-Isenburg, Germany; Luisenkrankenhaus Düsseldorf, Germany; Universitäts Frauenklinik Kiel, Germany; Onkologische Gemeinschaftspraxis, Frankfurt, Germany; Frauenklinik Ulm, Germany; Universitäts-Frauenklinik Rostock, Germany; SRH Wald Klinikum Gera, Germany; Universitätsklinikum Magdeburg, Germany; Medical University of Vienna, Austria; Sankt Gertrauden Krankenhaus, Berlin, Germany; Charité University, Berlin, Germany; Rotkruezklinikum München, Germany; Klinikum Offenbach, Germany; Kliniken Essen Mitte, Germany; University Erlangen, Germany; University Heidelberg; Klinikum Rechts der Isar der TU München, Germany; Helios Kliniken Berlin, Germany; Frauenklinik Frankfurt, Germany
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V Nekljudova
German Breast Group, Neu-Isenburg, Germany; Luisenkrankenhaus Düsseldorf, Germany; Universitäts Frauenklinik Kiel, Germany; Onkologische Gemeinschaftspraxis, Frankfurt, Germany; Frauenklinik Ulm, Germany; Universitäts-Frauenklinik Rostock, Germany; SRH Wald Klinikum Gera, Germany; Universitätsklinikum Magdeburg, Germany; Medical University of Vienna, Austria; Sankt Gertrauden Krankenhaus, Berlin, Germany; Charité University, Berlin, Germany; Rotkruezklinikum München, Germany; Klinikum Offenbach, Germany; Kliniken Essen Mitte, Germany; University Erlangen, Germany; University Heidelberg; Klinikum Rechts der Isar der TU München, Germany; Helios Kliniken Berlin, Germany; Frauenklinik Frankfurt, Germany
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K Mehta
German Breast Group, Neu-Isenburg, Germany; Luisenkrankenhaus Düsseldorf, Germany; Universitäts Frauenklinik Kiel, Germany; Onkologische Gemeinschaftspraxis, Frankfurt, Germany; Frauenklinik Ulm, Germany; Universitäts-Frauenklinik Rostock, Germany; SRH Wald Klinikum Gera, Germany; Universitätsklinikum Magdeburg, Germany; Medical University of Vienna, Austria; Sankt Gertrauden Krankenhaus, Berlin, Germany; Charité University, Berlin, Germany; Rotkruezklinikum München, Germany; Klinikum Offenbach, Germany; Kliniken Essen Mitte, Germany; University Erlangen, Germany; University Heidelberg; Klinikum Rechts der Isar der TU München, Germany; Helios Kliniken Berlin, Germany; Frauenklinik Frankfurt, Germany
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S Loibl
German Breast Group, Neu-Isenburg, Germany; Luisenkrankenhaus Düsseldorf, Germany; Universitäts Frauenklinik Kiel, Germany; Onkologische Gemeinschaftspraxis, Frankfurt, Germany; Frauenklinik Ulm, Germany; Universitäts-Frauenklinik Rostock, Germany; SRH Wald Klinikum Gera, Germany; Universitätsklinikum Magdeburg, Germany; Medical University of Vienna, Austria; Sankt Gertrauden Krankenhaus, Berlin, Germany; Charité University, Berlin, Germany; Rotkruezklinikum München, Germany; Klinikum Offenbach, Germany; Kliniken Essen Mitte, Germany; University Erlangen, Germany; University Heidelberg; Klinikum Rechts der Isar der TU München, Germany; Helios Kliniken Berlin, Germany; Frauenklinik Frankfurt, Germany
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DOI: 10.1158/0008-5472.SABCS13-S5-05 Published December 2013
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Abstracts: Thirty-Sixth Annual CTRC-AACR San Antonio Breast Cancer Symposium - Dec 10-14, 2013; San Antonio, TX

Abstract

Background: Patients with residual disease after neoadjuvant chemotherapy (NACT) are considered to have chemoresistant breast cancer. Adjuvant treatment with bisphosphonates is considered to reduce the relapse risk predominantly in estrogen-deprivated patients.

Methods: Patients who had invasive tumor residuals (ypT1-4 or ypN+) after a minimum of 4 cycles of anthracycline-taxane-containing NACT were eligible to the NATAN study. Patients were randomized within 3 years after surgery to receive zoledronate 4 mg i.v. (plus 1000 mg Ca2+ and 880 I.U. vitamin D daily) for 5 years vs. observation. Zoledronate was given q 4 weeks for the first 6 months, q 3 months the following 2 years, and q 6 months for the last 2.5 years. Patients with hormone receptor (HR)-positive disease received letrozole for 5 years if postmenopausal, or tamoxifen, if premenopausal. Adjuvant trastuzumab for HER2-positive disease was allowed since an amendment in 2007. Stratification factors were HR, time since surgery, age, and center. Primary objective was event-free survival (EFS). 654 patients and 316 events were required to observe an increase of 5yr EFS from 58% to 67.2% (hazard ratio 0.73). Secondary objectives were to determine overall survival, EFS with respect to the interval between surgery and randomization, bone-metastasis-free-survival, toxicity of and compliance to zoledronate, the predictive value of breast tumor response to NACT on the effect of postoperative treatment and the prognostic impact of chemotherapy induced amenorrhea in premenopausal patients. An interim analysis for high efficacy at 158 observed events was planned in the protocol; in agreement with study IDMC a Bayesian analysis for futility with futility boundary of 15% will be performed at the same time.

Results: Between 2/2005 and 5/2009 693 patients were enrolled. Time between surgery and randomization was <4 months in 48.4%, 4-12 months in 34.5%, and 13-36 months in 17.1% of patients. The median age was 50.9 yrs (range 33.7-88.2), 72.3% of patients were postmenopausal. 82% had HR-positive and 19% HER2-positive disease. During a median follow up of 48 months 154 events were observed so far.

Conclusion: This is the first post-neoadjuvant phase III study. Analysis of the primary endpoint will be presented in case the IDMC will release of the results of the futility analysis.

Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr S5-05.

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Cancer Research: 73 (24 Supplement)
December 2013
Volume 73, Issue 24 Supplement
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Abstract S5-05: Postneoadjuvant treatment with zoledronate in patients with tumor residuals after anthracyclines-taxane-based chemotherapy for primary breast cancer – The phase III NATAN study (GBG 36/ABCSG XX)
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Abstract S5-05: Postneoadjuvant treatment with zoledronate in patients with tumor residuals after anthracyclines-taxane-based chemotherapy for primary breast cancer – The phase III NATAN study (GBG 36/ABCSG XX)
G von Minckwitz, M Rezai, H Eidtmann, H Tesch, J Huober, B Gerber, DM Zahn, S Costa, M Gnant, JU Blohmer, C Denkert, C Hanusch, C Jackisch, S Kümmel, PA Fasching, A Schneeweiss, S Paepke, M Untch, V Nekljudova, K Mehta and S Loibl
Cancer Res December 15 2013 (73) (24 Supplement) S5-05; DOI: 10.1158/0008-5472.SABCS13-S5-05

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Abstract S5-05: Postneoadjuvant treatment with zoledronate in patients with tumor residuals after anthracyclines-taxane-based chemotherapy for primary breast cancer – The phase III NATAN study (GBG 36/ABCSG XX)
G von Minckwitz, M Rezai, H Eidtmann, H Tesch, J Huober, B Gerber, DM Zahn, S Costa, M Gnant, JU Blohmer, C Denkert, C Hanusch, C Jackisch, S Kümmel, PA Fasching, A Schneeweiss, S Paepke, M Untch, V Nekljudova, K Mehta and S Loibl
Cancer Res December 15 2013 (73) (24 Supplement) S5-05; DOI: 10.1158/0008-5472.SABCS13-S5-05
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General Session Abstracts

  • Abstract GS6-07: EMBRACA: A phase 3 trial comparing talazoparib, an oral PARP inhibitor, to physician's choice of therapy in patients with advanced breast cancer and a germline BRCA mutation
  • Abstract GS5-04: Prediction of occult invasive disease in ductal carcinoma in situ using deep learning features
  • Abstract GS1-02: NSABP B-47 (NRG oncology): Phase III randomized trial comparing adjuvant chemotherapy with adriamycin (A) and cyclophosphamide (C) → weekly paclitaxel (WP), or docetaxel (T) and C with or without a year of trastuzumab (H) in women with node-positive or high-risk node-negative invasive breast cancer (IBC) expressing HER2 staining intensity of IHC 1+ or 2+ with negative FISH (HER2-Low IBC)
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General Session 5

  • Abstract S5-01: The Connecticut experiment: 4 years of screening women with dense breasts with bilateral ultrasound
  • Abstract S5-03: Accelerated partial breast irradiation using intensity modulated radiotherapy versus whole breast irradiation: 5-year survival results of a phase 3 randomized trial
  • Abstract S5-06: Large-scale identification of cell-specific PARP substrates
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Cancer Research Online ISSN: 1538-7445
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