Metastatic Breast Cancer

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Mario Campone - One of the best experts on this subject based on the ideXlab platform.

  • a pharmacokinetic evaluation of alpelisib for the treatment of hr her2 negative pik3ca mutated advanced or Metastatic Breast Cancer
    Expert Opinion on Drug Metabolism & Toxicology, 2021
    Co-Authors: Marion Bertho, Jeansebastien Frenel, Anne Patsouris, Paule Augereau, Marie Robert, Cyriac Blonz, Mario Campone
    Abstract:

    Introduction: In most cases, Metastatic Breast Cancer remains an incurable disease. A PIK3CA mutation is detected in 30–40% of all hormone receptor-positive (HR+), human epidermal growth factor rec...

  • pertuzumab trastuzumab and docetaxel in her2 positive Metastatic Breast Cancer
    The New England Journal of Medicine, 2015
    Co-Authors: Sandra M Swain, Sungbae Kim, Jean-marc Ferrero, Andreas Schneeweiss, V F Semiglazov, Jose Baselga, Jungsil Ro, E. Ciruelos, Mario Campone, Sarah Heeson
    Abstract:

    Background In patients with Metastatic Breast Cancer that is positive for human epidermal growth factor receptor 2 (HER2), progression-free survival was significantly improved after first-line therapy with pertuzumab, trastuzumab, and docetaxel, as compared with placebo, trastuzumab, and docetaxel. Overall survival was significantly improved with pertuzumab in an interim analysis without the median being reached. We report final prespecified overall survival results with a median followup of 50 months. Methods We randomly assigned patients with Metastatic Breast Cancer who had not received previous chemotherapy or anti-HER2 therapy for their Metastatic disease to receive the pertuzumab combination or the placebo combination. The secondary end points of overall survival, investigator-assessed progression-free survival, independently assessed duration of response, and safety are reported. Sensitivity analyses were adjusted for patients who crossed over from placebo to pertuzumab after the interim analysis. Results The median overall survival was 56.5 months (95% confidence interval [CI], 49.3 to not reached) in the group receiving the pertuzumab combination, as compared with 40.8 months (95% CI, 35.8 to 48.3) in the group receiving the placebo combination (hazard ratio favoring the pertuzumab group, 0.68; 95% CI, 0.56 to 0.84; P<0.001), a difference of 15.7 months. This analysis was not adjusted for crossover to the pertuzumab group and is therefore conservative. Results of sensitivity analyses after adjustment for crossover were consistent. Median progression-free survival as assessed by investigators improved by 6.3 months in the pertuzumab group (hazard ratio, 0.68; 95% CI, 0.58 to 0.80). Pertuzumab extended the median duration of response by 7.7 months, as independently assessed. Most adverse events occurred during the administration of docetaxel in the two groups, with long-term cardiac safety maintained. Conclusions In patients with HER2-positive Metastatic Breast Cancer, the addition of per tuzumab to trastuzumab and docetaxel, as compared with the addition of placebo, significantly improved the median overall survival to 56.5 months and extended the results of previous analyses showing the efficacy of this drug combination. (Funded by F. Hoffmann–La Roche and Genentech; CLEOPATRA ClinicalTrials.gov number, NCT00567190.)

  • what is the best choice of partner chemotherapy with trastuzumab for Metastatic Breast Cancer
    Expert Review of Anticancer Therapy, 2012
    Co-Authors: Carole Gourmelon, Jeansebastien Frenel, Mario Campone
    Abstract:

    The HER2 gene and its role in pathogenicity in human Breast Cancer were detected in the 1980s. Trastuzumab is a monoclonal antibody directed against the HER2 membrane receptor. The aim of this article is to describe chemotherapy–trastuzumab combinations that have been evaluated in patients with HER2-positive Metastatic Breast Cancer, and to define the possible standards and options.

Nikola Bangemann - One of the best experts on this subject based on the ideXlab platform.

  • phase ii study of capecitabine plus trastuzumab in human epidermal growth factor receptor 2 overexpressing Metastatic Breast Cancer pretreated with anthracyclines or taxanes
    Journal of Clinical Oncology, 2007
    Co-Authors: G Schaller, I Fuchs, Thomas Gonsch, Jan Weber, Anke Kleinetebbe, P Klare, Hansjoachim Hindenburg, Volker Lakner, Axel Hinke, Nikola Bangemann
    Abstract:

    Purpose The oral fluoropyrimidine carbamate, capecitabine, is a highly active and well-tolerated treatment for Metastatic Breast Cancer. In patients treated previously with anthracyclines and taxanes, capecitabine is an approved single-agent therapy. Trastuzumab, a monoclonal antibody targeting the human epidermal growth factor receptor 2 (HER-2), is also highly active in HER-2–overexpressing Breast Cancer. We have conducted a phase II study to confirm activity and feasibility of capecitabine and trastuzumab in combination in HER-2–overexpressing advanced/Metastatic Breast Cancer. Patients and Methods Twenty-seven patients with HER-2–overexpressing Metastatic Breast Cancer previously treated with anthracyclines and/or taxanes received oral capecitabine 1,250 mg/m2 bid for 14 days followed by a 7-day rest period combined with intravenous trastuzumab 4 mg/kg body weight on day 1 (loading dose) followed by 2 mg/kg weekly. Results Capecitabine/trastuzumab treatment achieved objective responses in 12 patients ...

Kathleen C Horst - One of the best experts on this subject based on the ideXlab platform.

  • cost effectiveness of pertuzumab in human epidermal growth factor receptor 2 positive Metastatic Breast Cancer
    Journal of Clinical Oncology, 2016
    Co-Authors: Ben Y Durkee, Yushen Qian, Erqi L Pollom, Martin T King, S A Dudley, J Shaffer, Daniel T Chang, Iris C Gibbs, Jeremy D Goldhaberfiebert, Kathleen C Horst
    Abstract:

    PurposeThe Clinical Evaluation of Pertuzumab and Trastuzumab (CLEOPATRA) study showed a 15.7-month survival benefit with the addition of pertuzumab to docetaxel and trastuzumab (THP) as first-line treatment for patients with human epidermal growth factor receptor 2 (HER2) –overexpressing Metastatic Breast Cancer. We performed a cost-effectiveness analysis to assess the value of adding pertuzumab.Patient and MethodsWe developed a decision-analytic Markov model to evaluate the cost effectiveness of docetaxel plus trastuzumab (TH) with or without pertuzumab in US patients with Metastatic Breast Cancer. The model followed patients weekly over their remaining lifetimes. Health states included stable disease, progressing disease, hospice, and death. Transition probabilities were based on the CLEOPATRA study. Costs reflected the 2014 Medicare rates. Health state utilities were the same as those used in other recent cost-effectiveness studies of trastuzumab and pertuzumab. Outcomes included health benefits expres...

Carey K Anders - One of the best experts on this subject based on the ideXlab platform.

Geke A P Hospers - One of the best experts on this subject based on the ideXlab platform.

  • measuring residual estrogen receptor availability during fulvestrant therapy in patients with Metastatic Breast Cancer
    Cancer Discovery, 2015
    Co-Authors: Michel Van Kruchten, Elisabeth G E De Vries, Andor W J M Glaudemans, Meta C Van Lanschot, Martijn Van Faassen, Ido P Kema, Myles Brown, Carolien P Schroder, Erik F J De Vries, Geke A P Hospers
    Abstract:

    It is unknown whether the current dose of fulvestrant, an estrogen receptor (ER) downregulator, is sufficient for maximal ER downregulation in patients with Metastatic Breast Cancer. We performed a feasibility study to assess ER availability before and during fulvestrant. Sixteen patients with ER-positive Metastatic Breast Cancer underwent positron emission tomography/computed tomography (PET/CT) at baseline (Scan 1), day 28 (Scan 2) and day 84 (Scan 3) to monitor tumor [18F]fluoroestradiol (FES) uptake. Incomplete reduction in ER availability was predefined as < 75% decrease in median tumor FES uptake and a residual standardized uptake value (SUVmax) ≥ 1.5. In total 131 FES-positive lesions were identified (median SUVmax of 2.9, range 1.7-6.5). The median change in patients during fulvestrant treatment was -85% at Scan 2, but varied widely (-99% to +60%). Fulvestrant reduced tumor FES uptake incompletely at Scan 2 in 6 (38%) of the 16 patients, which was associated with early progression.

  • residual estrogen receptor availability during fulvestrant 500 mg therapy in patients with Metastatic Breast Cancer
    Journal of Clinical Oncology, 2014
    Co-Authors: Michel Van Kruchten, Elisabeth G E De Vries, Andor W J M Glaudemans, Ido P Kema, Myles Brown, Carolien P Schroder, Erik F J De Vries, Meta C Van Lanschot, Martijn Van Faassen, Geke A P Hospers
    Abstract:

    588 Background: Fulvestrant competitively binds the ER and can decrease its expression. However, it is currently unknown whether the standard dose of 500 mg intramuscularly (days 1, 14, 28 and every 4 weeks thereafter) in Metastatic Breast Cancer patients is sufficient for maximal ER downregulation. In a feasibility study we therefore evaluated whether fulvestrant 500 mg completely abolishes ER availability in patients with ER-positive Metastatic Breast Cancer. Methods: Sixteen patients received fulvestrant and underwent positron emission tomography/computed tomography (PET/CT) before therapy initiation (scan 1), on day 28 (scan 2) and day 84 (scan 3) to monitor tumor [18F]fluoroestradiol (FES) uptake. A relative decrease of <75% in the median (background-corrected) tumor FES uptake and a residual standardized uptake value (SUVmax) ≥1.5 was predefined as incomplete reduction in ER availability. Plasma fulvestrant levels were determined concurrently with the scans by liquid chromatography tandem mass spect...

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