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Freigegeben für Präsentation und Abgabe an Fachkreisangehörige

Freigegeben für Präsentation und Abgabe an Fachkreisangehörige. Planned recruitment : 300 patients ; No . o f sites : approx . 100; FPFV: June 2012; LPFV: June 2013; LPLV: May 2014

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Freigegeben für Präsentation und Abgabe an Fachkreisangehörige

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  1. Freigegeben für Präsentation und Abgabe an Fachkreisangehörige

  2. Plannedrecruitment: 300 patients; No. ofsites: approx. 100; • FPFV:June 2012; LPFV: June 2013; LPLV: May 2014 • Treatment duration: 48 weeksoruntilprogression, inacceptabletoxicityorwithdrawalofconsent. • Stratitfication: • First linetreatment vs. 2nd/3rdlinetreatment • Prior chemotherapy vs. nopriorchemotherapy • Prior Exemestanetreatment vs. nopriorExemestanetreatment

  3. Objectives • Primary objective • To assess the Overall Response Rate (ORR) in postmenopausal women with hormone receptor positive breast cancer progressing following prior therapy with NSAIs treated with the combination of Everolimus and Exemestane. • Secondary objectives • To evaluate the following objectives: • Progression free survival (PFS) • Overall survival (OS) • Safety • Change in QoL scores over time • Health resource utilization

  4. ExploratoryObjectives • Anxiety and depression: To screen metastatic breast cancer outpatients for anxiety and depression under Exemestane/Everolimus treatment, and to investigate the influence of age, performance status, cancer activity and inflammation (IL-6 levels) on these two mood disorders. • Bone turnover: Assess changes in serum bone-turnover biomarkers (e.g. PINP, CTx, Vitamin D, OPG, RANKL, SOST, FSH, Estradiol) • Pharmacogenetics of Everolimus in patients with advanced breast cancer:Association of germline genotype (DNA to be isolated from white blood cells) and characteristics of free circulating nucleic acids with the treatment response, long term prognosis, molecular tumor profile and treatment toxicity. • Presence and molecular characteristics of Circulating Tumor Cells: Association of treatment response and prognosis with presence and molecular characteristics of circulating tumor cells. • Proteomics: Correlation of response to Exemestane/Everolimus with Proteomics, i.e. autoantibodies to proteins of the mTOR-signaling pathway

  5. Population: • This study will be performed in 300 postmenopausal women with hormone receptor positive locally advanced or metastatic breast cancer progressing following prior therapy with non-steroidal aromatase inhibitors (NSAI) as defined by: • Recurrence while on or after completion of an adjuvant treatment including Letrozole or Anastrozole, or • Progression while on or following the completion of Letrozole or Anastrozole treatment for locally advanced or metastatic breast cancer • The treatment with Letrozole or Anastrazole must not have been the most current treatment prior to enrolment. • Patients may have already taken Exemestane. • Except for prior use of mTOR inhibitors, there are no restrictions as to the last anticancer treatment, i.e. chemotherapy or endocrine therapy prior to enrolment. • Patients must have documented evidence of recurrence or progression on or after the last therapy prior to enrollment: • Patients must have • at least one lesion that can be accurately measured or • bone lesions: lytic or mixed (lytic + sclerotic) in the absence of measurable disease.

  6. Amendment 1 • Bone scans may be replaced by whole body CT, provided that this is local standard. The whole body CT must be performed within a two weeks window of the visit. • Laboratory evaluations are to be performed according to local standard. • CT for chest, abdomen, pelvis may be replaced by MRT, if clinically contraindicated, e.g. allergy/sensitivity to the radiographic contrast media, metastatic presentation. • Local radiotherapy is allowed during the study duration for analgesic purpose or for lytic lesions at risk of fracture.

  7. Recruitmentcompleted in < 5 mo.25 Jun – 12 Nov 2012: 300 patients

  8. Recruitment Facts 25 Jun – 1 Dec 2012: 297 patients

  9. 4EVER Trial Sites

  10. PreliminaryBaseline Data Purposeof last treatment • Nur zur Präsentation, nicht zu Abgabe.

  11. BOLERO 2 vs. 4EVER • Freigegeben für Präsentation und Abgabe an Fachkreisangehörige • * BaselgaJ. et al. Everolimus in Postmenopausal Hormone-Receptor–Positive Advanced Breast Cancer. N Engl J Med 2012; 366:520-529.

  12. BOLERO-2: PFS für Everolimus in der 1stlineProgress oder Rezidiv während adjuvanter Therapie (zentrale Auswertung) 100 HR=0.32 (95% CI, 0.18-0.57) Kaplan-Meier medians 80 EVE+EXE: 15,24 Monate PBO+EXE: 4.21 Monate 60 Probability of Event, % 40 20 Censoringtimes EVE+EXE (n/N=36/100) PBO+EXE (n/N=19/37) 0 0 6 12 18 24 30 36 42 48 54 60 66 72 78 84 90 96 102 108 Time (wk) Patients at risk EVE+EXE 100 94 86 73 59 53 44 38 35 25 21 16 10 8 7 4 4 3 0 PBO+EXE 37 29 17 14 9 6 5 5 4 4 2 1 1 1 0 0 0 0 0 Abkürzungen: CI, confidenceinterval; EVE, everolimus; EXE, exemestane; HR, hazardratio; PBO, placebo; PFS, progression-freesurvival. Modifiziert nach Campone M. et al., posterpresentedatSt. Gallen International Breast Cancer Conference. 2013, Abstract 276

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