Palbociclib / Letrozole or Fulvestrant in African American Women With HR+ HER2- Breast Cancer (PALINA)
7 de setembro de 2021 atualizado por: Georgetown University
Phase II Safety Study of Palbociclib in Combination With Letrozole or Fulvestrant in African American Women With Hormone Receptor Positive HER2 Negative Advanced Breast Cancer
This study aims to evaluate the hematological safety of palbociclib with letrozole and fulvestrant in African American women with hormone receptor positive HER2 negative advanced breast cancer.
Hematological safety is a composite endpoint of episodes of febrile neutropenia and treatment discontinuation due to neutropenia according to current recommendations for management of neutropenia
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Descrição detalhada
The study is designed to assess the rate of completion of planned oncology therapy in the absence of a hematological event defined as episodes of febrile neutropenia and treatment discontinuation due to neutropenia. A completion rate of 80% is considered of clinical relevance as to benefit breast cancer patients who are at a higher risk of having ethnic neutropenia where as a completion rate of 60% is considered poor and to justify additional safety studies. A two stage design with a total of 35 patients is used to test if the completion rate is at least 80% versus if it is below 60% with 80% power at a significance level of 5%.
An exact confidence interval of the completion rate will be calculated. Investigators estimate there will be no more than a 10% rate of febrile neutropenia. Due to the small sample size, the analysis of secondary endpoints will be descriptive and will not include specific hypothesis testing.
Tipo de estudo
Intervencional
Inscrição (Real)
35
Estágio
- Fase 2
- 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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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20007
- MedStar Georgetown University Hospital
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Washington, District of Columbia, Estados Unidos, 20013
- MedStar Washington Hospital Center
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Illinois
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Chicago, Illinois, Estados Unidos, 60637
- University of Chicago
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Maryland
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Baltimore, Maryland, Estados Unidos, 21218
- MedStar Union Memorial Hospital
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Baltimore, Maryland, Estados Unidos, 21239
- MedStar Good Samaritan Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19107
- Thomas Jefferson University
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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:
- Self-identified Black, African or African American women of ≥ 18 years of age with proven diagnosis of advanced adenocarcinoma of the breast (locoregionally recurrent or metastatic disease)
- ER-positive and/or PgR-positive tumor based on local laboratory results
- HER2-negative breast cancer based on local laboratory results (test to be used as per local practice)
- Patients must be appropriate candidates for letrozole or fulvestrant therapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Adequate bone marrow function:
- Absolute Neutrophil Count (ANC) ≥ 1,000/mm3 (1.0 x 109/L);
- Platelets ≥100,000/mm3 (100 x 109/L);
- Hemoglobin ≥9 g/dL (90 g/L).
Exclusion Criteria:
- Current use of food or drugs known to be potent inhibitors or inducers of CYP3A4
- Active uncontrolled or symptomatic brain metastases. Previously treated and clinically stable, as per Investigator's judgment, brain metastases are permitted.
Previous CDK4/6 inhibitor
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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: Palbociclib + Letrozole or Fulvestrant
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Palbociclib x 21 days with a 7 day rest plus 2.5 mg Letrozole QD (no break) or Fulvestrant 500mg IM every 2 weeks for 3 doses and then every 4 weeks until progression or maximum of 12 months
Outros nomes:
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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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Number of Patients Who Complete Planned Oncologic Therapy Without the Development of a Hematological Event
Prazo: 12 months
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For study purpose febrile neutropenia will be defined according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0: "ANC less than 1000/mm3 with a single temperature of >38.3 degrees Celsius (101 degrees Fahrenheit) or a sustained temperature of 38 degrees Celsius (100.4 degrees Fahrenheit) for more than one hour." Planned oncology therapy is defined as completion of one year of therapy for advanced breast cancer in the absence of disease progression or cessation of study drug due to progressive disease or non-hematological toxicity. |
12 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Dose Delays in Palbociclib Attributed to Neutropenia
Prazo: 12 months
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Number of patients who required dose delays in palbociclib attributed to neutropenia.
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12 months
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Dose Reductions in Palbociclib Therapy Attributed to Neutropenia
Prazo: 12 months
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Number of patients who required dose reductions in palbociclib therapy
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12 months
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Clinical Benefit Rate
Prazo: 24 weeks
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Clinical Benefit Rate (CBR), for those with evaluable disease, defined as the percentage of patients who achieved complete response, partial response and stable disease.
RECIST 1.1 was used as the standard way to measure response to treatment.
The mean (SD) of specific metabolites were calculated at each time point and graphically assess these measures over time with clinical response and hematological toxicity.
The mean change in these variables from baseline to each follow-up point was be calculated.
Generalized linear model was utilized for the correlative analysis of clinical response and hematologic events.
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24 weeks
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Claudine Isaacs, MD, MedStar Georgetown University Hospital
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
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- A study of Palbociclib (PD-0332991) + letrozole vs. letrozole for first line treatment of postmenopausal women with ER/HER2- advanced breast cancer (PALOMA-2). Available at: https://clinicaltrials.gov/ct2/show/NCT01740427. Accessed on August 9, 2015
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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)
1 de setembro de 2016
Conclusão Primária (Real)
16 de dezembro de 2019
Conclusão do estudo (Real)
23 de março de 2021
Datas de inscrição no estudo
Enviado pela primeira vez
23 de fevereiro de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
25 de fevereiro de 2016
Primeira postagem (Estimativa)
26 de fevereiro de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
28 de setembro de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de setembro de 2021
Última verificação
1 de agosto de 2021
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
- Hormônios, Substitutos Hormonais e Antagonistas Hormonais
- Agentes Antineoplásicos Hormonais
- Inibidores de proteína quinase
- Antagonistas Hormonais
- Inibidores de Aromatase
- Inibidores da Síntese de Esteróides
- Antagonistas de Estrogênio
- Antagonistas dos receptores de estrogênio
- Letrozol
- Fulvestranto
- Palbociclibe
Outros números de identificação do estudo
- 2015-1396
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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 .