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

6 kwietnia 2020 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

235

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Kobieta

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: everolimus + exemestane
Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily
Lek: 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
Inne nazwy:
  • RAD001
Lek: exemestane
25 mg tablet was administered orally once daily on a continuous dosing schedule starting on Day 1

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Participants Response Rates (Best Overall and Overall)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Novartis Pharmaceuticals

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

29 marca 2013

Zakończenie podstawowe (Rzeczywisty)

29 stycznia 2019

Ukończenie studiów (Rzeczywisty)

29 stycznia 2019

Daty rejestracji na studia

Pierwszy przesłany

1 czerwca 2017

Pierwszy przesłany, który spełnia kryteria kontroli jakości

1 czerwca 2017

Pierwszy wysłany (Rzeczywisty)

5 czerwca 2017

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

7 kwietnia 2020

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

6 kwietnia 2020

Ostatnia weryfikacja

1 kwietnia 2020

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CRAD001JIC06

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Post Menopausal Breast Cancer

Badania kliniczne na everolimus

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Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Oman

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

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