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

6. april 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

235

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: everolimus + exemestane
Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily
Medicin: 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
Andre navne:
  • RAD001
Medicin: exemestane
25 mg tablet was administered orally once daily on a continuous dosing schedule starting on Day 1

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Response Rates (Best Overall and Overall)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novartis Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. marts 2013

Primær færdiggørelse (Faktiske)

29. januar 2019

Studieafslutning (Faktiske)

29. januar 2019

Datoer for studieregistrering

Først indsendt

1. juni 2017

Først indsendt, der opfyldte QC-kriterier

1. juni 2017

Først opslået (Faktiske)

5. juni 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. april 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. april 2020

Sidst verificeret

1. april 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CRAD001JIC06

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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