Um estudo de alisertibe em combinação com terapia endócrina em pacientes com câncer de mama metastático ou recorrente HR-positivo, HER2-negativo (ALISCA-Breast1)
Um estudo de fase 2 de alisertibe em combinação com terapia endócrina em pacientes com câncer de mama HR+, HER2-negativo recorrente ou metastático
PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast cancer (MBC) following progression on or after at least two prior lines of endocrine therapy in the recurrent or metastatic setting. This study is intended to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy. Participants randomized prior to Amendment 4 are randomized 1:1:1 to Arm 1, Arm 2 or Arm 3. Participants randomized under Amendment 4 will be randomized 1:1 to Arm 1 or Arm 2.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
Contactos e Locais
Contato de estudo
- Nome: Puma Biotechnology, Inc. Clinical Operations Senior Director
- Número de telefone: 424-248-6500
- E-mail: ClinicalTrials@pumabiotechnology.com
Locais de estudo
-
-
-
Alicante, Espanha, 03010
- Recrutamento
- Hospital General Universitario Dr. Balmis
-
Barakaldo, Espanha, 48903
- Recrutamento
- Hospital Universitario de Cruces
-
Barcelona, Espanha, 08035
- Recrutamento
- Hospital Universitario Vall d'Hebron
-
Barcelona, Espanha, 08036
- Recrutamento
- Hospital Clínico de Barcelona
-
Bilbao, Espanha, 48013
- Recrutamento
- Hospital Universitario de Basurto
-
Cáceres, Espanha, 10003
- Recrutamento
- Hospital San Pedro de Alcántara
-
Granada, Espanha, 18012
- Recrutamento
- Hospital San Cecilio
-
Huelva, Espanha, 21005
- Recrutamento
- Hospital Universitario Juan Ramon Jimenez
-
Jaén, Espanha, 23007
- Recrutamento
- Hospital Universitario de Jaén
-
Lleida, Espanha, 25198
- Recrutamento
- Hospital Universitario Arnau de Vilanova
-
Madrid, Espanha, 28040
- Recrutamento
- Hospital Universitario Fundación Jiménez Díaz
-
Seville, Espanha, 41013
- Recrutamento
- Hospital Universitario Virgen del Rocío
-
Valencia, Espanha, 46010
- Recrutamento
- Hospital Clínico Universitario de Valencia
-
Valencia, Espanha, 46009
- Recrutamento
- Fundación Instituto Valenciano de Oncología (IVO)
-
-
-
-
Alabama
-
Birmingham, Alabama, Estados Unidos, 34235
- Recrutamento
- Alabama Oncology
-
-
Arizona
-
Phoenix, Arizona, Estados Unidos, 85054
- Recrutamento
- Mayo Clinic Hospital
-
-
California
-
Beverly Hills, California, Estados Unidos, 90211
- Recrutamento
- Beverly Hills Cancer Center
-
Fountain Valley, California, Estados Unidos, 92708
- Recrutamento
- MemorialCare Orange Coast Medical Center
-
Irvine, California, Estados Unidos, 92618
- Recrutamento
- City of Hope at Orange County Lennar Foundation Cancer Center
-
Los Angeles, California, Estados Unidos, 90095
- Recrutamento
- UCLA Department of Medicine - Hematology/Oncology
-
Los Angeles, California, Estados Unidos, 90017
- Recrutamento
- LA Cancer Network
-
San Francisco, California, Estados Unidos, 94158
- Recrutamento
- University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
-
-
Colorado
-
Aurora, Colorado, Estados Unidos, 80045
- Recrutamento
- University of Colorado School of Medicine
-
-
Connecticut
-
New Haven, Connecticut, Estados Unidos, 06520
- Retirado
- Yale University, Yale Cancer Center
-
-
Florida
-
Jacksonville, Florida, Estados Unidos, 32256
- Recrutamento
- Cancer Specialists of North Florida
-
Jacksonville, Florida, Estados Unidos, 32224
- Recrutamento
- Mayo Clinic Florida
-
Tampa, Florida, Estados Unidos, 33612
- Recrutamento
- Moffitt Cancer Center
-
-
Georgia
-
Atlanta, Georgia, Estados Unidos, 30322
- Recrutamento
- Winship Cancer Institute, Emory University
-
-
Illinois
-
Chicago, Illinois, Estados Unidos, 60612
- Recrutamento
- University of Illinois Cancer Center
-
Chicago, Illinois, Estados Unidos, 60637
- Recrutamento
- The University of Chicago
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02114
- Recrutamento
- Massachusetts General Hospital
-
Boston, Massachusetts, Estados Unidos, 02215
- Recrutamento
- Dana-Farber Cancer Institute
-
-
Minnesota
-
Minneapolis, Minnesota, Estados Unidos, 55455
- Recrutamento
- University of Minnesota, Masonic Cancer Center
-
Rochester, Minnesota, Estados Unidos, 55905
- Recrutamento
- Mayo Clinic
-
-
Missouri
-
Columbia, Missouri, Estados Unidos, 65201
- Recrutamento
- Missouri Cancer Associates
-
Kansas City, Missouri, Estados Unidos, 64111
- Recrutamento
- Saint Luke's Cancer Institute
-
Springfield, Missouri, Estados Unidos, 65807
- Recrutamento
- Oncology Hematology Associates
-
St Louis, Missouri, Estados Unidos, 63110
- Recrutamento
- Washington University School of Medicine
-
-
Nevada
-
Reno, Nevada, Estados Unidos, 89511
- Recrutamento
- Cancer Care Specialists
-
-
New York
-
Rochester, New York, Estados Unidos, 14642
- Recrutamento
- University of Rochester Medical Center
-
-
North Carolina
-
Chapel Hill, North Carolina, Estados Unidos, 27514
- Recrutamento
- UNC Hospitals, University of North Carolina at Chapel Hill
-
-
Ohio
-
Columbus, Ohio, Estados Unidos, 43212
- Recrutamento
- The Ohio State University, Stefanie Spielman Comprehensive Breast Center
-
Maumee, Ohio, Estados Unidos, 43537
- Recrutamento
- Taylor Cancer Research Center
-
-
Pennsylvania
-
Horsham, Pennsylvania, Estados Unidos, 19044
- Recrutamento
- Alliance Cancer Specialists
-
Philadelphia, Pennsylvania, Estados Unidos, 19104
- Recrutamento
- University of Pennsylvania, Abramson Cancer Center, Perelman Center for Advanced Medicine
-
Pittsburgh, Pennsylvania, Estados Unidos, 15213
- Recrutamento
- University of Pittsburgh (UPMC)
-
-
Tennessee
-
Nashville, Tennessee, Estados Unidos, 37203
- Recrutamento
- Tennessee Oncology, Greco-Hainsworth Center for Research
-
-
Texas
-
Dallas, Texas, Estados Unidos, 75246
- Recrutamento
- Texas Oncology
-
-
Virginia
-
Richmond, Virginia, Estados Unidos, 23229
- Recrutamento
- Virginia Cancer Institute
-
-
-
-
-
Lisbon, Portugal, 1998-018
- Recrutamento
- Hospital CUF Descobertas
-
Lisbon, Portugal, 1099-023
- Recrutamento
- Instituto Português de Oncologia de Lisboa Francisco Gentil (IPO Lisboa)
-
Lisbon, Portugal, 1400-038
- Recrutamento
- Fundação Champalimaud
-
Porto, Portugal, 4200-072
- Recrutamento
- Instituto Português Oncologia Do Porto
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Aged ≥18 years at signing of informed consent.
- Pathology-confirmed diagnosis of breast cancer with evidence of recurrent or metastatic disease not amenable to curative therapy.
- Progression on or after treatment with at least two prior lines of endocrine therapy in the recurrent or metastatic setting. a. If metastatic disease recurrence occurs during or within six months of discontinuing adjuvant endocrine therapy, then that endocrine therapy will count as one line of prior therapy.
- Participants must have received a CDK4/6i in combination with endocrine therapy in the recurrent or metastatic setting.
- HR-positive and HER2-negative tumor status reported per local laboratory testing. HR and HER2 testing must be performed consistent with current American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) or European Society of Medical Oncology (ESMO) guidelines.
Exclusion Criteria:
- Treatment with chemotherapy in the recurrent or metastatic setting, including antibody drug conjugates with a chemotherapeutic payload.
- Prior treatment with an Aurora Kinase A (AURKA) specific-targeted or pan-Aurora-targeted agent, including alisertib, in any setting.
Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Alisertib 50 mg
Alisertib with selected endocrine therapy |
Alisertib enteric-coated tablets will be taken by mouth twice daily on days 1-3, 8-10, and 15-17 of each 28-day cycle.
Outros nomes:
Investigator selected endocrine therapy will be taken in 28-day dosing cycles according to the approved prescribing information. 1 mg of anastrozole tablet by mouth once daily or 2.5 mg of letrozole tablet by mouth once daily or 25 mg of exemestane tablet by mouth once daily or 20 mg of tamoxifen tablet by mouth once daily or 500 mg of fulvestrant intramuscular injection on Study Day 1, 15, 29, and once every 28 days thereafter |
|
Experimental: Alisertib 40 mg
Alisertib with selected endocrine therapy |
Alisertib enteric-coated tablets will be taken by mouth twice daily on days 1-3, 8-10, and 15-17 of each 28-day cycle.
Outros nomes:
Investigator selected endocrine therapy will be taken in 28-day dosing cycles according to the approved prescribing information. 1 mg of anastrozole tablet by mouth once daily or 2.5 mg of letrozole tablet by mouth once daily or 25 mg of exemestane tablet by mouth once daily or 20 mg of tamoxifen tablet by mouth once daily or 500 mg of fulvestrant intramuscular injection on Study Day 1, 15, 29, and once every 28 days thereafter |
|
Experimental: Alisertib 30 mg
Alisertib with selected endocrine therapy Cohort closed to enrollment in Amendment 4 |
Alisertib enteric-coated tablets will be taken by mouth twice daily on days 1-3, 8-10, and 15-17 of each 28-day cycle.
Outros nomes:
Investigator selected endocrine therapy will be taken in 28-day dosing cycles according to the approved prescribing information. 1 mg of anastrozole tablet by mouth once daily or 2.5 mg of letrozole tablet by mouth once daily or 25 mg of exemestane tablet by mouth once daily or 20 mg of tamoxifen tablet by mouth once daily or 500 mg of fulvestrant intramuscular injection on Study Day 1, 15, 29, and once every 28 days thereafter |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Objective Response Rate (ORR) Within Dose Subgroup
Prazo: From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
|
Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study. |
From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
|
|
Duration of Response (DOR) Within Dose Subgroup
Prazo: From start date of response (after date of randomization) to first PD, assessed up to 48 months
|
Duration of response is measured from the time at which measurement criteria are first met for Complete Response (CR) or Partial Response (PR) (whichever status is recorded first) until the first date of recurrence or progressive disease (PD) or death is objectively documented. |
From start date of response (after date of randomization) to first PD, assessed up to 48 months
|
|
Disease Control Rate (DCR) Within Dose Subgroup
Prazo: From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
|
Disease control rate is the proportion of participants who achieve overall tumor response (confirmed CR or PR) or Stable Disease (SD) lasting for at least 24 weeks from randomization. |
From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
|
|
Progression Free Survival (PFS) Within Dose Subgroup
Prazo: From date of randomization to date of recurrence, progression or death, assessed up to 48 months
|
Progression Free Survival (PFS) is measured in months and based on the local tumor assessment. The time interval from the date of randomization until the first date on which recurrence, progression, or death due to any cause, is documented. |
From date of randomization to date of recurrence, progression or death, assessed up to 48 months
|
|
Overall Survival (OS) Within Dose Subgroup
Prazo: From date of randomization to death, assessed up to 48 months
|
Overall survival (OS) is defined as the time from randomization to death due to any cause, censored at the last date known alive on or prior to the data cutoff employed for the analysis, whichever was earlier. |
From date of randomization to death, assessed up to 48 months
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) in the Enrolled Population
Prazo: From date of first dose through last dose plus 28 days, assessed up to 48 months
|
Treatment emergent adverse events are those events reported on or after the first dose of investigational product and up to 28 days after last dose. |
From date of first dose through last dose plus 28 days, assessed up to 48 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Objective Response Rate (ORR) Within Biomarker-Defined Subgroup
Prazo: From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
|
Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study. |
From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
|
|
Duration of Response (DOR) Within Biomarker-Defined Subgroup
Prazo: From start date of response (after date of randomization) to first PD, assessed up to 48 months
|
Duration of response is measured from the time at which measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of recurrence or progressive disease (PD) or death is objectively documented. |
From start date of response (after date of randomization) to first PD, assessed up to 48 months
|
|
Disease Control Rate (DCR) Within Biomarker-Defined Subgroup
Prazo: From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
|
Disease control rate is the proportion of participants who achieve overall tumor response (confirmed CR or PR) or SD lasting for at least 24 weeks from randomization. |
From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
|
|
Progression Free Survival (PFS) Within Biomarker-Defined Subgroup
Prazo: From date of randomization to date of recurrence, progression or death, assessed up to 48 months
|
Progression Free Survival (PFS) is measured in months and based on the local tumor assessment. The time interval from the date of randomization until the first date on which recurrence, progression, or death due to any cause, is documented. |
From date of randomization to date of recurrence, progression or death, assessed up to 48 months
|
|
Overall Survival (OS) Within Biomarker-Defined Subgroup
Prazo: From date of randomization to death, assessed up to 48 months
|
Overall survival (OS) is defined as the time from randomization to death due to any cause, censored at the last date known alive on or prior to the data cutoff employed for the analysis, whichever was earlier. |
From date of randomization to death, assessed up to 48 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Chief Reg Affairs, PV, Medical Affairs and Law Officer, Puma Biotechnology, Inc.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PUMA-ALI-1201
- 2024-511497-79-00 (Ctis)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.
In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.
Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information.
Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.
Prazo de Compartilhamento de IPD
Clinical study documents and clinical trial data may be requested by qualified researchers and study participants for studies that have been completed for at least 18 months, and for which the indication of the drug has been approved in the US and/or EU, as applicable. Requests will be accepted for up to 24 months after the criteria described in this section are met.
Critérios de acesso de compartilhamento IPD
Requestors must provide organizational contact information; a detailed research plan, including outcomes; timeline for completion of the research; qualifications of the research team; funding source; and potential conflicts of interest.
Puma will not provide access to patient-level data if there is a reasonable likelihood that individual patients could be identified, or in cases where confidentiality or consent provisions prohibit transfer of data or information to third parties. Additionally, Puma will not disclose information that jeopardizes intellectual property rights or divulges confidential commercial information.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .