Nadia Harbeck

Kliniken Essen-Mitte Knappschafts-Krankenhaus, Essen, North Rhine-Westphalia, Germany

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Publications (381)1279.97 Total impact

  • [Show abstract] [Hide abstract]
    ABSTRACT: The antibody-drug conjugate trastuzumab emtansine (T-DM1) combines the cytotoxic activity of DM1 with the human epidermal growth factor receptor 2 (HER2) -targeted, antitumor properties of trastuzumab. T-DM1 has shown activity in phase I and II single-arm studies in patients with pretreated HER2-positive metastatic breast cancer (MBC) and has demonstrated superior efficacy and improved tolerability versus standard MBC treatments in randomized phase II and III studies. This analysis, combining available data from all single-agent T-DM1 studies to date, was conducted to better define the T-DM1 safety profile.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 07/2014;
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    ABSTRACT: Taxane-based adjuvant chemotherapy is standard in node-positive (N+) early breast cancer (BC). The magnitude of benefit in intermediate-risk N+ early BC is still unclear. WSG-AGO EC-Doc is a large trial evaluating modern taxane-based chemotherapy in patients with 1-3 positive lymph nodes (LN) only. 2011 BC patients (18-65 years, pN1) were entered into a randomized phase III trial comparing 4xE90C600 q3w followed by 4xdocetaxel100 q3w (n=1008) to current standard: 6xF500E100C500 q3w (n=828) or C600M40F600 d1, 8 q4w (n=175). Primary endpoint was event-free survival (EFS); secondary endpoints were overall survival (OS), toxicity, translational research, and quality of life (QoL). Central tumor bank samples were evaluable in a representative collective (n=772; 40%). Ki-67 was assessed centrally in hormone receptor positive disease as surrogate marker for distinction of luminal A/B-like tumors. Baseline characteristics were well balanced between study arms in both main study and central tumor bank subset. At 59 months median follow-up, superior efficacy of EC-Doc (vs. FEC) was seen in EFS and OS: 5-y EFS: 89.8% vs. 87.3% (p=0.038); 5-y OS: 94.5 vs. 92.8% (p=0.034); both tests one-tailed. EC-Doc caused more toxicity. In HR+ disease, only high-Ki-67 tumors (>20%) derived significant benefit from taxane-based therapy: hazard ratio=0.39 (95% CI: 0.18-0.82) for EC-Doc vs. FEC (test for interaction; p=0.01). EC-Doc significantly improved EFS and OS vs. FEC in intermediate-risk BC (1-3 LN) within all subgroups as defined by local pathology. In HR+ disease, patients with luminal A-like tumors may be potentially over-treated by taxane-based chemotherapy.
    Annals of Oncology 05/2014; · 7.38 Impact Factor
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    ABSTRACT: The 1st International Consensus Conference for Breast Cancer in Young Women (BCY1) took place in November 2012, in Dublin, Ireland organized by the European School of Oncology (ESO). Consensus recommendations for management of breast cancer in young women were developed and areas of research priorities were identified. This manuscript summarizes these international consensus recommendations, which are also endorsed by the European Society of Breast Specialists (EUSOMA).
    Breast (Edinburgh, Scotland) 04/2014; · 2.09 Impact Factor
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    ABSTRACT: Our phase IIa study characterized the safety and efficacy of two human epidermal growth factor receptor 2 (HER2) -targeted agents, trastuzumab emtansine (T-DM1) and pertuzumab, in patients with HER2-positive metastatic breast cancer (MBC). Patients with HER2-positive locally advanced breast cancer or MBC were treated with 3.6 mg/kg T-DM1 plus pertuzumab (840-mg loading dose, then 420 mg subsequently) once every 3 weeks. The primary efficacy end point was investigator-assessed objective response rate (ORR). Sixty-four patients (43 patients in the second-line or greater setting [advanced MBC]; 21 patients in the first-line setting [first-line MBC]) were enrolled. Patients with advanced MBC had received trastuzumab and a median of six prior nonhormonal treatments for MBC; 86% of first-line MBC patients had received trastuzumab in the (neo)adjuvant setting. The ORR was 41% overall, 33% in patients with advanced MBC, and 57% in first-line patients. Median progression-free survival was 6.6, 5.5, and 7.7 months, respectively. The most common adverse events were fatigue (61%), nausea (50%), and diarrhea (39%). The most frequent grade ≥ 3 adverse events were thrombocytopenia (13%), fatigue (11%), and liver enzyme elevations (increased ALT: 9%; increased AST: 9%). One patient had left ventricular ejection fraction of less than 40% after study drug discontinuation. Exploratory biomarker analyses demonstrated that patients with above-median tumor HER2 mRNA levels had a numerically higher ORR than patients with below-median levels (44% v33%, respectively). T-DM1 and pertuzumab can be combined at full doses with no unexpected toxicities. The preliminary efficacy in patients in the first-line and advanced MBC settings warrants further investigation.
    Journal of Clinical Oncology 04/2014; · 18.04 Impact Factor
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    ABSTRACT: Invasive lobular carcinomas (ILC) show better clinical behaviour compared with other histological types, but significantly lower pathological complete response (pCR) rates after neoadjuvant chemotherapy (NACT). We investigated whether factors influencing pCR rate in ILC after NACT can be identified and whether clinical outcome is different. 9,020 breast cancer patients from nine German neoadjuvant trials with known histological type were pooled. 11.7 % of tumours were ILC. Endpoints were: pCR rate, surgery type and survival. ILC was associated with older age, larger tumour size, lymph node negativity, lower grade and positive hormone-receptor-status (HR). Patients with ILC achieved a significantly lower pCR rate compared with non-ILC patients (6.2 vs. 17.4 %, P < 0.001). The pCR rate was 4.2 % in ILC/HR+/G1-2, 7.0 % in ILC with either HR- or G3, and 17.8 % in ILC/HR-/G3. Mastectomy rate was higher in ILC compared with non-ILC patients irrespective of response to NACT (pCR: 27.4 vs. 16.6 %, P = 0.037 and non-pCR: 41.8 % vs. 31.5 %, P < 0.0001). Age and HR independently predicted pCR in ILC. In ILC patients, pCR did not predict distant disease free (DDFS) and loco-regional disease free survival (LRFS), but overall survival (OS). Non-pCR patients with ILC had significantly better DDFS (P = 0.018), LRFS (P < 0.0001) and OS (P = 0.044) compared with non-ILC patients. Patients with ILC had a low chance of obtaining a pCR and this is not well correlated with further outcome. The mastectomy rate was considerably high in ILC patients even after obtaining a pCR. We, therefore, suggest to offer NACT mainly to ILC patients with HR-negative tumours.
    Breast Cancer Research and Treatment 02/2014; · 4.47 Impact Factor
  • Christoph Thomssen, Nadia Harbeck
    Breast Care 02/2014; 9(1):5-6. · 0.68 Impact Factor
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    ABSTRACT: The Advanced Breast Cancer Second International Consensus Conference (ABC2) on diagnosis and treatment of advanced breast cancer took place in Lisbon, Portugal, on November 7-9, 2013. The focus of the conference was inoperable, locally advanced breast cancer. The diagnosis and treatment of metastatic breast cancer had already been discussed 2 years before at the ABC1 Consensus and were only updated regarding special issues as part of this year's ABC2 Consensus. Like 2 years ago, a working group of German breast cancer experts commented on the voting results of the ABC panelists, with special consideration of the German guidelines for the diagnosis and treatment of breast cancer (German Gynecological Oncology Working Group (AGO) recommendations, S3 Guideline) in order to adapt them for daily clinical practice in Germany. The goal of both the ABC Consensus and the German comments is to facilitate evidence-based therapy decisions.
    Breast Care 02/2014; 9(1):52-9. · 0.68 Impact Factor
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    ABSTRACT: Background Clinical decision-making in patients with early stage breast cancer requires adequate risk estimation by medical oncologists. This survey evaluates the agreement among oncologists on risk estimations and adjuvant systemic treatment (AST) decisions and the impact of adding the 70-gene signature to known clinico-pathological factors. Methods Twelve medical oncologists assessed 37 breast cancer cases (cT1–3N0M0) and estimated their risk of recurrence (high or low) and gave a recommendation for AST. Cases were presented in two written questionnaires sent 4 weeks apart. Only the second questionnaire included the 70-gene signature result. Results The level of agreement among oncologists in risk estimation (κ = 0.57) and AST recommendation (κ = 0.57) was ‘moderate’ in the first questionnaire. Adding the 70-gene signature result significantly increased the agreement in risk estimation to ‘substantial’ (κ = 0.61), while agreement in AST recommendations remained ‘moderate’ (κ = 0.56). Overall, the proportion of high risk was reduced with 7.4% (range: 6.9–22.9%; p < 0.001) and the proportion of chemotherapy that was recommended was reduced with 12.2% (range: 5.4–29.5%; p < 0.001). Conclusion Oncologists’ risk estimations and AST recommendations vary greatly. Even though the number of participating oncologists is low, our results underline the need for a better standardisation tool in clinical decision-making, in which integration of the 70-gene signature may be helpful in certain subgroups to provide patients with individualised, but standardised treatment.
    European journal of cancer (Oxford, England: 1990) 01/2014; · 4.12 Impact Factor
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    ABSTRACT: WSG-ARA plus trial evaluated the effect of adjuvant darbepoetin alfa (DA) on outcome in node positive primary breast cancer (BC). One thousand two hundred thirty-four patients were randomized to chemotherapy either with DA (DA+; n = 615) or without DA (DA-; n = 619). DA (500 µg q3w) was started at hemoglobin (Hb) levels <13.0 g/dl (<12 g/dl after DA label amendment) and stopped at Hb levels ≥14.0 g/dl (12 g/dl after label amendment). Primary efficacy end point was event-free survival (EFS); secondary end points were toxicity, quality of life (QoL) and overall survival (OS). Venous thrombosis (DA+: 3.0%, DA-: 1.0%; P = 0.013) was significantly higher for DA+, but not pulmonary embolism (0.3% in both arms). Median Hb levels were stable in DA+ (12.6 g/dl) and decreased in DA- (11.7 g/dl). Hb levels >15 g/dl were reported in 0.8% of cycles. QoL parameters did not significantly differ between arms. At 39 months, DA had no significant impact on EFS (DA+: 89.3%, DA-: 87.5%; Plog-rank = 0.55) or OS (DA+: 95.5%, DA-: 95.4%; Plog-rank = 0.77). DA treatment did not impact EFS or OS in routine adjuvant BC treatment.
    Annals of Oncology 01/2014; 25(1):75-80. · 7.38 Impact Factor
  • Nadia Harbeck, Flavio Solca, Thomas C Gauler
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    ABSTRACT: Aberrant signaling of the ErbB family of receptors plays an integral role in the tumorigenesis of many cancer types, including head and neck squamous cell carcinoma (HNSCC) and breast cancer (BC). Significant research efforts have focused on developing new treatments that target ErbB family members, with the last decade seeing the approval of small-molecule tyrosine kinase inhibitors and monoclonal antibodies that inhibit ErbB signaling. However, treatment resistance is an ever-growing problem and, therefore, new therapies are being investigated to overcome this hurdle. Afatinib is an irreversible ErbB family blocker that has demonstrated potent anti-tumor activity in preclinical models and has displayed clinical efficacy in patients with non-small-cell lung cancer, and activity in HNSCC and BC. Here, the preclinical and clinical development of afatinib in the treatment of non-small-cell lung cancer, HNSCC and BC is described in the context of currently approved agents.
    Future Oncology 01/2014; 10(1):21-40. · 3.20 Impact Factor
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    ABSTRACT: The 1st International Consensus Conference for Breast Cancer in Young Women (BCY1) took place in November 2012, in Dublin, Ireland organized by the European School of Oncology (ESO). Consensus recommendations for management of breast cancer in young women were developed and areas of research priorities were identified. This manuscript summarizes these international consensus recommendations, which are also endorsed by the European Society of Breast Specialists (EUSOMA).
    The Breast. 01/2014;
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    ABSTRACT: This prospective study evaluated the relationship between arthralgia and compliance during the first year of adjuvant anastrozole therapy in postmenopausal women with hormone receptor-positive early breast cancer. COMPliance and Arthralgia in Clinical Therapy (COMPACT) was an open-label, multicenter, noninterventional study conducted in Germany. Patients had started adjuvant anastrozole 3-6 months before the study start. The primary end points were arthralgia, compliance, and the relationship between compliance and arthralgia, assessed at specific time points. Overall, 1916 patients received upfront anastrozole. Mean arthralgia scores were increased from baseline at each visit up to 9 months. Compliance with anastrozole therapy gradually decreased over time from baseline to 9 months (P < 0.001). At 9 months, investigators estimated that >95% of patients were compliant versus patient reports of <70%. There was a significant association between arthralgia mean scores and noncompliance at 6 months (P < 0.0001), 9 months (P < 0.0001), and overall (P < 0.0001). Over time, new events or impairment of existing arthralgias were reported in 14% (3 months), 11% (6 months), and 9% (9 months) of patients. Arthralgia is important in the clinical management of women with early breast cancer and may contribute to noncompliance and clinical outcomes. NCT00857012.
    Annals of Oncology 12/2013; · 7.38 Impact Factor
  • Christoph Thomssen, Nadia Harbeck
    Breast Care 12/2013; 8(6):455-6. · 0.68 Impact Factor
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    ABSTRACT: The developments in gene expression analysis have made it possible to sub-classify hormone receptor-positive (luminal) breast cancer in different prognostic subgroups. This sub-classification is currently used in clinical routine as prognostic signature (e.g. 21-gene Onoctype DX®, 70-gene Mammaprint®). As yet, the optimal method for sub-classification has not been defined. Moreover, there is no evidence from prospective trials. This review explores widely used genomic signatures in luminal breast cancer, making a critical appraisal of evidence from retrospective/prospective trials. It is based on systematic literature search performed using Medline (accessed September 2013) and abstracts presented at the Annual Meeting of American Society of Clinical Oncology and San Antonio Breast Cancer Symposium.
    Breast Care 12/2013; 8(6):414-422. · 0.68 Impact Factor
  • Nadia Harbeck, Rachel Wuerstlein
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    ABSTRACT: With the advent of the monoclonal antibody trastuzumab over 2 decades ago for breast cancer therapy, the outcome of patients with human epidermal growth factor receptor (HER) 2-positive disease has improved dramatically. Based on its substantial efficacy and good tolerability, trastuzumab has become the therapeutic gold standard for early as well as advanced breast cancer. Nevertheless, despite adjuvant trastuzumab, patients do experience recurrence and require further anti-HER2-targeted therapy. Next to the small molecule tyrosine kinase inhibitor lapatinib, which was the first approved therapy option after trastuzumab failure, several new anti-HER2 agents are currently already available for clinical use [i.e. pertuzumab, T-DM1 (trastuzumab emtansine)] or are still being evaluated (e.g. afatinib, neratinib). Recent evidence from neoadjuvant as well as metastatic therapy suggests that dual blockade may be superior to single-agent HER2 blockade. While the number of available or potential therapies has increased considerably, no additional predictive biomarkers beyond HER2 have been validated for the use of the different anti-HER2 therapies. Moreover, novel therapeutic concepts such as the antibody-drug conjugate T-DM1 warrant excellent determination methodology for HER2 and suggest re-evaluation of tumor biology upon first metastasis. The clinical challenge remains to optimally choose, utilize, and sequence anti-HER2 therapy in early as well as metastatic breast cancer. This article will provide evidence-based guidance for sequencing anti-HER2 therapy throughout the continuum of breast cancer therapy.
    Drugs 10/2013; · 4.63 Impact Factor
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    ABSTRACT: Targeting HER2 with multiple HER2-directed therapies represents a promising area of treatment for HER2-positive cancers. We investigated combining the HER2-directed antibody-drug conjugate trastuzumab emtansine (T-DM1) with the HER2 dimerization inhibitor pertuzumab (Perjeta™). Drug combination studies with T-DM1 and pertuzumab were performed on cultured tumor cells and in mouse xenograft models of HER2-amplified cancer. In patients with HER2-positive locally advanced or metastatic breast cancer, T-DM1 was dose-escalated with a fixed standard pertuzumab dose in a 3+3 Phase Ib/II study design. Treatment of HER2-overexpressing tumor cells in vitro with T-DM1 plus pertuzumab resulted in synergistic inhibition of cell proliferation and induction of apoptotic cell death. The presence of the HER3 ligand, heregulin (NRG-1β) reduced the cytotoxic activity of T-DM1 in a subset of breast cancer lines; this effect was reversed by the addition of pertuzumab. Results from mouse xenograft models showed enhanced anti-tumor efficacy with T-DM1 and pertuzumab resulting from the unique anti-tumor activities of each agent. In patients with metastatic breast cancer previously treated with trastuzumab, lapatinib, and chemotherapy, T-DM1 could be dosed at the maximum tolerated dose (MTD, 3.6 mg/kg every 3 weeks) with standard-dose pertuzumab. Adverse events were mostly Grade 1 and 2, with indications of clinical activity. Dual-targeting of HER2 with the combination of T-DM1 and pertuzumab in cell culture and mouse xenograft models resulted in enhanced anti-tumor activity. In patients, this combination showed an encouraging safety and tolerability profile with preliminary evidence of efficacy.
    Clinical Cancer Research 10/2013; · 7.84 Impact Factor
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    ABSTRACT: Paraneoplastic hypoglycemia is a rare syndrome amoung tumorous diseases. It is often associated with a paraneoplastic secretion of 'big' insulin-like growth factor-II. We describe this syndrome in a 60-year-old patient with advanced breast cancer 8 years after primary diagnosis. This non-islet cell tumor-induced hypoglycemia may be the only evidence for an otherwise clinically occult disease progression. Fast diagnosis and appropriate acute and causal treatment concepts should be part of oncological management.
    Breast Care 10/2013; 8(5):368-70. · 0.68 Impact Factor
  • Nadia Harbeck
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    ABSTRACT: The American Society of Clinical Oncology 2013 Annual Meeting took place from May 31 until June 4 2013 in Chicago (IL, USA). Highlights within the area of gynecological oncology and breast cancer included two studies in cervical cancer addressing screening as well as treatment of advanced disease. In breast cancer, the presented studies covered a wide range of topics from local therapy to targeted therapy in the advanced setting. They were not practice changing but rather for the most part confirmatory of earlier findings. Last but not least, a positive Phase III study, BOLERO III, proved the hypothesis that trastuzumab resistance can be overcome by intracellular signal transduction using the mTOR inhibitor everolimus.
    Future Oncology 10/2013; 9(10):1433-1436. · 3.20 Impact Factor
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    ABSTRACT: In early breast cancer (eBC), established clinicopathological factors are not sufficient for clinical decision making particularly regarding adjuvant chemotherapy since substantial over- or undertreatment may occur. Thus, novel protein- and molecular markers have been put forward as decision aids. Since these potential prognosis and/or predictive tests differ substantially regarding their methodology, analytical and clinical validation, this review attempts to summarize the essential facts for clinicians. This review focuses on those markers which are the most advanced so far in their development towards routine clinical application, i.e. two protein markers (i.e. uPA/PAI-1 and IHC4) and six molecular multigene tests (i.e. Mammaprint®, Oncotype DX®, PAM50, Endopredict®, the 97-gene genomic grade, and 76 gene Rotterdam signatures). Next to methodological aspects, we summarized the clinical evidences, in particular the main prospective clinical trials which have already been fully recruited (i.e. MINDACT, TAILORx, WSG PLAN B) or are still ongoing (i.e. RxPONDER/SWOG S1007, WSG-ADAPT). Last but not least, this review points out the key elements for clinicians to select one test among the wide panel of proposed assays, for a specific population of patients in term of level of evidence, analytical and clinical validity as well as cost effectiveness.
    Cancer Treatment Reviews 09/2013; · 6.02 Impact Factor
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    ABSTRACT: Everolimus has shown to stop formation and activity of osteoclasts. Breast cancer patients with bone metastases only are candidates for effective but low toxic treatment. We evaluated everolimus in a double-blind, placebo-controlled, phase II, randomized discontinuation study in breast cancer patients with HER2 negative breast cancer patients with bone metastases only. After being stable on 8 weeks of everolimus 10 mg/day, patients were randomized to everolimus-continuation or placebo. Primary outcome was time (from randomization) to progression (TTP). Seventy-six patients would have had to be randomized to show a hazard ration (HR) of 0.5 for everolimus-continuation. Eighty-nine patients were enrolled in 4 years. Thirty-nine patients with SD after 8 weeks on everolimus were randomized to everolimus-continuation or placebo. TTP in patients with everolimus-continuation was 37.0 (95 % CI 16.7-40.3) versus 12.6 weeks (95 % CI 7.1-17.9) with placebo [HR 0.554 (95 % CI 0.282-1.09) p = 0.0818], adjusted for endocrine therapy [HR 0.464 (95 % CI 0.226-0.954) p = 0.037]. TTP in everolimus responders (n = 6) was 86 weeks. The RADAR study is mainly hypothesis generating. It suggests that everolimus has single-agent activity, and patients with bone metastases only may retrieve long-term benefit from everolimus if they do not progress within 8 weeks of treatment.
    Journal of Cancer Research and Clinical Oncology 09/2013; · 2.91 Impact Factor

Publication Stats

6k Citations
1,279.97 Total Impact Points


  • 2013
    • Kliniken Essen-Mitte Knappschafts-Krankenhaus
      Essen, North Rhine-Westphalia, Germany
    • Paracelsus Medical University Salzburg
      Salzburg, Salzburg, Austria
  • 2012–2013
    • Philipps University of Marburg
      Marburg, Hesse, Germany
    • University of Duisburg-Essen
      Essen, North Rhine-Westphalia, Germany
    • Massachusetts General Hospital
      Boston, Massachusetts, United States
    • US Oncology
      The Woodlands, Texas, United States
    • European School of Oncology
      Milano, Lombardy, Italy
  • 1994–2013
    • Ludwig-Maximilian-University of Munich
      • • Department of Internal Medicine II
      • • Clinic and Polyclinic for Obstetrics and Gynecology
      München, Bavaria, Germany
  • 2010–2012
    • Martin Luther University of Halle-Wittenberg
      • Klinik und Poliklinik für Gynäkologie
      Halle-on-the-Saale, Saxony-Anhalt, Germany
    • Hospital Frankfurt Hoechst
      Frankfurt, Hesse, Germany
  • 2011
    • Kantonsspital St. Gallen
      San Gallo, Saint Gallen, Switzerland
    • Medical University of Vienna
      Wien, Vienna, Austria
  • 2008–2011
    • German Breast Group
      Neulsenburg, Hesse, Germany
    • Johannes Gutenberg-Universität Mainz
      Mayence, Rheinland-Pfalz, Germany
  • 2007–2011
    • University of Cologne
      Köln, North Rhine-Westphalia, Germany
  • 1991–2011
    • Technische Universität München
      • • Institut für Medizinische Statistik und Epidemiologie
      • • Frauenklinik und Poliklinik
      München, Bavaria, Germany
  • 2009–2010
    • Epigenomics
      Berlin Mitte, Berlin, Germany
    • Technische Universität Dresden
      Dresden, Saxony, Germany
    • The University of Edinburgh
      • Department of Clinical Biochemistry
      Edinburgh, SCT, United Kingdom
  • 1995–2010
    • Deutsches Herzzentrum München
      München, Bavaria, Germany
  • 2004–2009
    • Erasmus MC
      • Department of Internal Oncology
      Rotterdam, South Holland, Netherlands
    • The American Society for Biochemistry and Molecular Biology
      Атина, Georgia, United States
    • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
      Milano, Lombardy, Italy
  • 2006
    • University of Toronto
      • Department of Laboratory Medicine and Pathobiology
      Toronto, Ontario, Canada
    • University of British Columbia - Vancouver
      Vancouver, British Columbia, Canada
  • 2005
    • University of Chicago
      • Department of Obstetrics & Gynecology
      Chicago, IL, United States
  • 2003–2004
    • Mount Sinai Hospital, Toronto
      • Department of Pathology and Laboratory Medicine
      Toronto, Ontario, Canada
    • University of Hamburg
      • Department of Gynaecology
      Hamburg, Hamburg, Germany
  • 2002
    • Goethe-Universität Frankfurt am Main
      Frankfurt, Hesse, Germany
  • 1998–2001
    • University Medical Center Hamburg - Eppendorf
      Hamburg, Hamburg, Germany
  • 1999
    • University Hospital München
      München, Bavaria, Germany