Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer (EVEREXES)
6 de abril de 2020 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
235
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Australian Capital Territory
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Garran, Australian Capital Territory, Austrália, 2605
- Novartis Investigative Site
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New South Wales
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Caringbah, New South Wales, Austrália, 2229
- Novartis Investigative Site
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Liverpool, New South Wales, Austrália, 2170
- Novartis Investigative Site
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Victoria
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Box Hill, Victoria, Austrália, 3128
- Novartis Investigative Site
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Heidelberg, Victoria, Austrália, 3084
- Novartis Investigative Site
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Ringwood East, Victoria, Austrália, 3135
- Novartis Investigative Site
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St Albans, Victoria, Austrália, 3021
- Novartis Investigative Site
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Bandung, Indonésia, 40161
- Novartis Investigative Site
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Jakarta, Indonésia, 11420
- Novartis Investigative Site
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Jogyakarta, Indonésia, 55284
- Novartis Investigative Site
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Semarang, Indonésia, 50212
- Novartis Investigative Site
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Amman, Jordânia, 11941
- Novartis Investigative Site
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MYS
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Kuala Lumpur, MYS, Malásia, 56000
- Novartis Investigative Site
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Sabah
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Kota Kinabalu, Sabah, Malásia, 88586
- Novartis Investigative Site
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Wilayah Persekutuan
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Kuala Lumpur, Wilayah Persekutuan, Malásia, 50586
- Novartis Investigative Site
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Casablanca, Marrocos
- Novartis Investigative Site
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Rabat, Marrocos, 6527
- Novartis Investigative Site
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Ankara, Peru, 06100
- Novartis Investigative Site
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Ankara, Peru, 06500
- Novartis Investigative Site
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Ankara, Peru, 06460
- Novartis Investigative Site
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Gaziantep, Peru, 27310
- Novartis Investigative Site
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Izmir, Peru, 35040
- Novartis Investigative Site
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Kartal, Peru, 34890
- Novartis Investigative Site
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Pendik / Istanbul, Peru, 34899
- Novartis Investigative Site
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Busan, Republica da Coréia, 602739
- Novartis Investigative Site
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Jeollanam-do, Republica da Coréia, 519763
- Novartis Investigative Site
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Seoul, Republica da Coréia, 03080
- Novartis Investigative Site
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Seoul, Republica da Coréia, 06351
- Novartis Investigative Site
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Seoul, Republica da Coréia, 03722
- Novartis Investigative Site
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Seoul, Republica da Coréia, 02841
- Novartis Investigative Site
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Seoul, Republica da Coréia, 06273
- Novartis Investigative Site
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Seoul, Republica da Coréia, 01812
- Novartis Investigative Site
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Taegu, Republica da Coréia, 41944
- Novartis Investigative Site
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Gyeonggi-do
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Suwon, Gyeonggi-do, Republica da Coréia, 443380
- Novartis Investigative Site
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Korea
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Gyeonggi do, Korea, Republica da Coréia, 10408
- Novartis Investigative Site
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Seoul, Korea, Republica da Coréia, 05505
- Novartis Investigative Site
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Seocho Gu
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Seoul, Seocho Gu, Republica da Coréia, 06591
- Novartis Investigative Site
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Bangkok, Tailândia, 10400
- Novartis Investigative Site
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Bangkok, Tailândia, 10300
- Novartis Investigative Site
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Chiang Mai, Tailândia, 50200
- Novartis Investigative Site
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Changhua, Taiwan, 50006
- Novartis Investigative Site
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Kaohsiung City, Taiwan, 83301
- Novartis Investigative Site
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Kaoshiung, Taiwan, 80756
- Novartis Investigative Site
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Taipei, Taiwan, 10048
- Novartis Investigative Site
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Taipei, Taiwan, 10449
- Novartis Investigative Site
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TWN
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New Taipei City, TWN, Taiwan, 23561
- Novartis Investigative Site
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Ariana, Tunísia, 2080
- Novartis Investigative Site
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Ho Chi Minh, Vietnã, 700000
- Novartis Investigative Site
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Western Cape, África do Sul, 7925
- Novartis Investigative Site
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Western Cape
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Cape Town, Western Cape, África do Sul, 7925
- Novartis Investigative Site
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George, Western Cape, África do Sul, 6530
- Novartis Investigative Site
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Gujarat
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Karamsad, Gujarat, Índia, 388325
- Novartis Investigative Site
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Maharashtra
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Nashik, Maharashtra, Índia, 422 004
- Novartis Investigative Site
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Pune, Maharashtra, Índia, 411013
- Novartis Investigative Site
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Orissa
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Cuttack, Orissa, Índia, 753 007
- Novartis Investigative Site
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: everolimus + exemestane
Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily
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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
Outros nomes:
25 mg tablet was administered orally once daily on a continuous dosing schedule starting on Day 1
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades
Prazo: 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
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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.
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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
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Percentage of Participants Response Rates (Best Overall and Overall)
Prazo: Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries
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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
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Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries
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Percentage of Participants Clinical Benefit Rate
Prazo: Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries
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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.
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Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries
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Progression Free Survival (PFS)
Prazo: Baseline up to approximately 43 weeks for Asian countires and 40 weeks for Non-Asian countries
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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
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Percent of Participants Event-free Probability Estimates of Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status
Prazo: Baseline up to approximately 50 weeks
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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.
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Baseline up to approximately 50 weeks
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
29 de março de 2013
Conclusão Primária (Real)
29 de janeiro de 2019
Conclusão do estudo (Real)
29 de janeiro de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
1 de junho de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de junho de 2017
Primeira postagem (Real)
5 de junho de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
7 de abril de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
6 de abril de 2020
Última verificação
1 de abril de 2020
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças de pele
- Neoplasias
- Neoplasias por local
- Doenças da mama
- Neoplasias da Mama
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores Enzimáticos
- Agentes Antineoplásicos
- Agentes imunossupressores
- Fatores imunológicos
- Hormônios, Substitutos Hormonais e Antagonistas Hormonais
- Antagonistas Hormonais
- Inibidores de Aromatase
- Inibidores da Síntese de Esteróides
- Antagonistas de Estrogênio
- Everolimo
- Exemestano
Outros números de identificação do estudo
- CRAD001JIC06
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em everolimus
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Seung-Jung ParkAbbott Medical Devices; CardioVascular Research Foundation, KoreaRescindidoDoença arterial coronáriaTailândia, Republica da Coréia, China, Malásia