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Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer (EVEREXES)

6 avril 2020 mis à jour par: Novartis Pharmaceuticals

A Phase IIIb, Multi-center, Open-label Study of RAD001 in Combination With EXemestane in Post-menopausal Women With EStrogen Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Locally Advanced or Metastatic Breast Cancer

This international, multi-center, open-label, single-arm study evaluated the safety and tolerability profile of everolimus in post-menopausal women with HR positive, HER2 negative locally advanced or metastatic breast cancer after documented recurrence or progression following a non-steroidal aromatase inhibitors (NSAI) therapy in Novartis Oncology emergent growth market (EGM) countries.Data was presented by Asian countries vs Non-Asian countries to confirm no difference in safety and efficacy. Summary statistics were presented.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

235

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Afrique du Sud
      • Western Cape, Afrique du Sud, 7925
        • Novartis Investigative Site
    • Western Cape
      • Cape Town, Western Cape, Afrique du Sud, 7925
        • Novartis Investigative Site
      • George, Western Cape, Afrique du Sud, 6530
        • Novartis Investigative Site
  • Australie
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australie, 2605
        • Novartis Investigative Site
    • New South Wales
      • Caringbah, New South Wales, Australie, 2229
        • Novartis Investigative Site
      • Liverpool, New South Wales, Australie, 2170
        • Novartis Investigative Site
    • Victoria
      • Box Hill, Victoria, Australie, 3128
        • Novartis Investigative Site
      • Heidelberg, Victoria, Australie, 3084
        • Novartis Investigative Site
      • Ringwood East, Victoria, Australie, 3135
        • Novartis Investigative Site
      • St Albans, Victoria, Australie, 3021
        • Novartis Investigative Site
  • Corée, République de
      • Busan, Corée, République de, 602739
        • Novartis Investigative Site
      • Jeollanam-do, Corée, République de, 519763
        • Novartis Investigative Site
      • Seoul, Corée, République de, 03080
        • Novartis Investigative Site
      • Seoul, Corée, République de, 06351
        • Novartis Investigative Site
      • Seoul, Corée, République de, 03722
        • Novartis Investigative Site
      • Seoul, Corée, République de, 02841
        • Novartis Investigative Site
      • Seoul, Corée, République de, 06273
        • Novartis Investigative Site
      • Seoul, Corée, République de, 01812
        • Novartis Investigative Site
      • Taegu, Corée, République de, 41944
        • Novartis Investigative Site
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Corée, République de, 443380
        • Novartis Investigative Site
    • Korea
      • Gyeonggi do, Korea, Corée, République de, 10408
        • Novartis Investigative Site
      • Seoul, Korea, Corée, République de, 05505
        • Novartis Investigative Site
    • Seocho Gu
      • Seoul, Seocho Gu, Corée, République de, 06591
        • Novartis Investigative Site
  • Inde
    • Gujarat
      • Karamsad, Gujarat, Inde, 388325
        • Novartis Investigative Site
    • Maharashtra
      • Nashik, Maharashtra, Inde, 422 004
        • Novartis Investigative Site
      • Pune, Maharashtra, Inde, 411013
        • Novartis Investigative Site
    • Orissa
      • Cuttack, Orissa, Inde, 753 007
        • Novartis Investigative Site
  • Indonésie
      • Bandung, Indonésie, 40161
        • Novartis Investigative Site
      • Jakarta, Indonésie, 11420
        • Novartis Investigative Site
      • Jogyakarta, Indonésie, 55284
        • Novartis Investigative Site
      • Semarang, Indonésie, 50212
        • Novartis Investigative Site
  • Jordan
      • Amman, Jordan, 11941
        • Novartis Investigative Site
  • Malaisie
    • MYS
      • Kuala Lumpur, MYS, Malaisie, 56000
        • Novartis Investigative Site
    • Sabah
      • Kota Kinabalu, Sabah, Malaisie, 88586
        • Novartis Investigative Site
    • Wilayah Persekutuan
      • Kuala Lumpur, Wilayah Persekutuan, Malaisie, 50586
        • Novartis Investigative Site
  • Maroc
      • Casablanca, Maroc
        • Novartis Investigative Site
      • Rabat, Maroc, 6527
        • Novartis Investigative Site
  • Taïwan
      • Changhua, Taïwan, 50006
        • Novartis Investigative Site
      • Kaohsiung City, Taïwan, 83301
        • Novartis Investigative Site
      • Kaoshiung, Taïwan, 80756
        • Novartis Investigative Site
      • Taipei, Taïwan, 10048
        • Novartis Investigative Site
      • Taipei, Taïwan, 10449
        • Novartis Investigative Site
    • TWN
      • New Taipei City, TWN, Taïwan, 23561
        • Novartis Investigative Site
  • Thaïlande
      • Bangkok, Thaïlande, 10400
        • Novartis Investigative Site
      • Bangkok, Thaïlande, 10300
        • Novartis Investigative Site
      • Chiang Mai, Thaïlande, 50200
        • Novartis Investigative Site
  • Tunisie
      • Ariana, Tunisie, 2080
        • Novartis Investigative Site
  • Turquie
      • Ankara, Turquie, 06100
        • Novartis Investigative Site
      • Ankara, Turquie, 06500
        • Novartis Investigative Site
      • Ankara, Turquie, 06460
        • Novartis Investigative Site
      • Gaziantep, Turquie, 27310
        • Novartis Investigative Site
      • Izmir, Turquie, 35040
        • Novartis Investigative Site
      • Kartal, Turquie, 34890
        • Novartis Investigative Site
      • Pendik / Istanbul, Turquie, 34899
        • Novartis Investigative Site
  • Viêt Nam
      • Ho Chi Minh, Viêt Nam, 700000
        • Novartis Investigative Site

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

  • Postmenopausal women with metastatic, recurrent or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.
  • Histological or cytological confirmation of hormone-receptor positive (HR+) breast cancer.
  • Disease refractory to non-steroidal aromatase inhibitors, defined as:
  • Recurrence while on, or within 12 months (365 days) of completion of adjuvant therapy with letrozole or anastrozole, or
  • Progression while on, or within one month (30 days) of completion of letrozole or anastrozole treatment for locally advanced or metastatic breast cancer (ABC).
  • Radiological or objective evidence of recurrence or progression on or after the last systemic therapy prior to enrolment.
  • Patients must have had:

  • At least one lesion that could have been accurately measured in at least one dimension

    • 20 mm with conventional imaging techniques or ≥ 10 mm with spiral CT or MRI, or
  • Bone lesions: lytic or mixed (lytic + blastic) in the absence of measurable disease as defined above.
  • Adequate bone marrow, coagulation, liver and renal function.
  • ECOG performance status ≤ 2.

Exclusion Criteria:

  • Patients overexpressing HER2 by local laboratory testing (IHC 3+ staining or in situ hybridization positive). Patients with IHC 2+ must have a negative in situ hybridization test.
  • Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites).
  • Patients with more than one prior chemotherapy line for ABC. A chemotherapy line is an anticancer regimen(s) that contained at least 1 cytotoxic chemotherapy agent, given for a minimum of 21 days.
  • Previous treatment with mTOR inhibitors.
  • Known hypersensitivity to mTOR inhibitors, e.g. Sirolimus (rapamycin).
  • Patients with a known history of HIV seropositivity. Screening for HIV infection at baseline was not required.
  • Patient who were being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A
  • History of brain or other CNS metastases, including leptomeningeal metastasis.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: everolimus + exemestane
Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily
Médicament: everolimus
one 10 mg tablet or two 5 mg tablets of everolimus were administered orally once daily on a continuous dosing schedule starting on Day 1
Autres noms:
  • RAD001
Médicament: exemestane
25 mg tablet was administered orally once daily on a continuous dosing schedule starting on Day 1

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades
Délai: Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries including a 30 day post treatment follow up period
Adverse events (AEs), serious adverse events (SAEs), changes from baseline in vital signs and laboratory results (hematology, blood chemistry, lipid profile) qualifying and reported as AEs. Although a patient might had two or more adverse events the patient is only counted once in a category. The same patient might appear in different categories. AESI: Adverse events of special interest.
Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries including a 30 day post treatment follow up period

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants Response Rates (Best Overall and Overall)
Délai: Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries
The best overall response for each patient is determined from the sequence of investigator overall lesion responses according to RECIST 1.1: Complete Response (CR)=disappearance of target lesions, Partial Response (PR) was >=30% decrease in sum of diameter of lesions, Progressive Disease (PD) was >=20% decrease in sum of diameter of lesions, Stable Disease (SD) does not qualify for PR, CR or PD, Unknown=not documented or assessed. To be assigned a best overall response of CR at least two determinations of CR at least 4 weeks apart before progression are required. To be assigned a best overall response of PR at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) are required. The Overall response rate (ORR) is the percentage of patients with a best overall response of confirmed complete (CR) or partial (PR) response. The 95% confidence intervals (CI) were computed using the Clopper-Pearson method
Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries
Percentage of Participants Clinical Benefit Rate
Délai: Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries
Clinical benefit rate: Patients with best overall response rate of CR (any duration), PR (any duration) and SD with duration of 24 weeks or longer according to RECIST 1.1 criteria: Complete Response (CR)=disappearance of target lesions, Partial Response (PR) was >=30% decrease in sum of diameter of lesions, Progressive Disease (PD) was >=20% decrease in sum of diameter of lesions, Stable Disease (SD) does not qualify for PR, CR or PD, Unknown=not documented or assessed. Best overall response of CR = at least two determinations of CR at least 4 weeks apart before progression are required. Best overall response of PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) are required. The Overall response rate (ORR) is the percentage of patients with a best overall response of confirmed complete (CR) or partial (PR) response. The 95% confidence intervals (CI) were computed using the Clopper-Pearson method.
Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries
Progression Free Survival (PFS)
Délai: Baseline up to approximately 43 weeks for Asian countires and 40 weeks for Non-Asian countries

PFS is time from date of start of treatment to date of disease progression or death due to any cause, whichever occurs first.

b Percentiles with 95% CIs are calculated from PROC LIFETEST output using method of Brookmeyer and Crowley (1982)
Baseline up to approximately 43 weeks for Asian countires and 40 weeks for Non-Asian countries
Percent of Participants Event-free Probability Estimates of Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status
Délai: Baseline up to approximately 50 weeks
Time to deterioration of ECOG performance status, from baseline will be assessed using the ECOG Performance Status Scale (Oken, 1982). Time to deterioration is the time from date of start of treatment to the date of the event defined as deterioration. Deterioration is defined as an increase in performance status from 0 to 2 or greater, an increase in performance status from 1-2 to 3 or greater, or death due to any cause. Event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point. Event-free probability estimates were are obtained from the Kaplan-Meier survival estimates.
Baseline up to approximately 50 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Novartis Pharmaceuticals

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

29 mars 2013

Achèvement primaire (Réel)

29 janvier 2019

Achèvement de l'étude (Réel)

29 janvier 2019

Dates d'inscription aux études

Première soumission

1 juin 2017

Première soumission répondant aux critères de contrôle qualité

1 juin 2017

Première publication (Réel)

5 juin 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

7 avril 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 avril 2020

Dernière vérification

1 avril 2020

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CRAD001JIC06

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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