Ensaio clínico em Câncer de Mama Metastático - Registro de Ensaios Clínicos

Visão geral do estudo

Status

Concluído

Condições

Câncer de Mama Metastático

Descrição detalhada

Os pacientes com BC metastático/localmente avançado HR+/HER2- cuja decisão de tratamento com palbociclibe foi tomada por seu médico assistente e que atendem aos critérios de elegibilidade serão convidados a participar do estudo. Os pacientes que iniciarem o tratamento com palbociclibe mais letrozol/inibidor de aromatase ou palbociclibe mais fulvestranto de acordo com a(s) indicação(ões) licenciada(s), como terapia de primeira ou segunda linha para BC metastático/localmente avançado na inscrição podem ser incluídos no estudo.

As variáveis avaliadas neste estudo serão dados demográficos do paciente, características clínicas, comorbidades e medicações concomitantes, histórico de tratamento HR+ HER2-localmente avançado e metastático para BC, tratamento atual para BC, status de desempenho (Eastern Cooperative Oncology Group (ECOG), resultados clínicos e QV. Todas as avaliações descritas neste protocolo são realizadas como parte da prática clínica normal ou diretrizes de prática padrão para a população de pacientes e profissionais de saúde especializados nos países onde este estudo não intervencional está sendo conduzido. Todos os dados coletados neste estudo destinam-se a capturar os padrões de tratamento do mundo real e os resultados para pacientes com BC metastático/localmente avançado HR+/HER2-. Um formulário eletrônico de relato de caso (eCRF) será usado para a coleta de dados. Os investigadores serão treinados com uma visita inicial à clínica no protocolo, sistema de captura eletrônica de dados (EDC) (ou seja, eCRF), arquivo mestre do local do investigador (ISMF), documentação e quaisquer processos de estudo aplicáveis. Qualquer nova informação relevante para a realização deste estudo não intervencional (NIS) será encaminhada à equipe médica durante o estudo. O monitoramento remoto de dados será conduzido durante a vida do estudo para garantir a comunicação oportuna de dados de segurança, integridade e consistência dos dados.

Tipo de estudo

Observacional

Inscrição (Real)

185

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

Arábia Saudita
- - Dammam, Arábia Saudita
    - King Fahad Specialist Hospital KFSH-Dammam
  - Riyadh, Arábia Saudita
    - National Guard Hospital, Riyadh
Catar
- - Doha, Catar
    - Hamad Medical Corporation
Egito
- - Alexandria, Egito
    - Alexandria School of Medicine/Clinical Research Center CRC
  - Cairo, Egito, 11796
    - National Cancer Institute
  - Cairo, Egito
    - Ain Shams University Hospital
  - Cairo, Egito, 11745
    - Dar El Salam Oncology Hospital
Jordânia
- - Amman, Jordânia, 11941
    - King Hussein Cancer Center
Líbano
- - Beirut, Líbano
    - American University of Beirut Medical Center
  - Beirut, Líbano
    - Hôtel Dieu de France (HDF)
  - Jdeidé - Metn, Líbano
    - Saint Joseph Hospital - Cancer Centers of Colorado
  - Sidon, Líbano
    - Hammoud Hospital University Medical Center (HHUMC)

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 a 90 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

Pacientes com câncer de mama metastático/localmente avançado HR+/HER2-

Descrição

Critério de inclusão:

≥18 anos ou mais com diagnóstico de adenocarcinoma da mama com evidência de doença metastática/localmente avançada não passível de tratamento com intenção curativa.
Tumor HR+ (ER+ e/ou PR+) documentado com base em padrões locais
Tumor HER2 documentado com base em padrões locais
Iniciará o tratamento com palbociclibe mais letrozol/inibidor de aromatase ou palbociclibe mais fulvestranto de acordo com a(s) indicação(ões) licenciada(s), como terapia de primeira ou segunda linha para BC metastático/localmente avançado na inscrição
Pacientes que, na opinião do investigador, estão dispostos e são capazes de cumprir visitas clínicas regulares
Evidência de um documento de consentimento informado pessoalmente assinado e datado, indicando que o paciente (ou um representante legalmente aceitável) foi informado de todos os aspectos pertinentes do estudo

Critério de exclusão:

Pacientes que participam de qualquer ensaio clínico intervencionista
Pacientes em tratamento ativo para malignidades diferentes de BC metastático/localmente avançado no momento da inscrição
Pacientes que não conseguem entender a natureza do estudo e não estão dispostos a assinar um consentimento informado

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

Modelos de observação: Coorte
Perspectivas de Tempo: Prospectivo

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Percentage of Participants Who Were Progression Free at 6 Months Post Palbociclib Initiation Prazo: At 6 months from the date of palbociclib initiation in routine clinical practice	Percentage of participants who were progression free was defined as percentage of participants who were alive and for whom no progression of disease was reported. Progression of disease was defined as an increase in visible disease and/or presence of any new lesions, which were evaluated as per local guidelines by the clinician and were collected in the electronic case report form (e-CRF). Kaplan-Meier method was used.	At 6 months from the date of palbociclib initiation in routine clinical practice
Percentage of Participants Who Were Progression Free at 12 Months Post Palbociclib Initiation Prazo: At 12 months from the date of palbociclib initiation in routine clinical practice	Percentage of participants who were progression free was defined as percentage of participants who were alive and for whom no progression of disease was reported. Progression of disease was defined as an increase in visible disease and/or presence of any new lesions, which were evaluated as per local guidelines by the clinician and were collected in the e-CRF. Kaplan-Meier method was used.	At 12 months from the date of palbociclib initiation in routine clinical practice
Percentage of Participants Who Were Progression Free at 18 Months Post Palbociclib Initiation Prazo: At 18 months from the date of palbociclib initiation in routine clinical practice	Percentage of participants who were progression free was defined as percentage of participants who were alive and for whom no progression of disease was reported. Progression of disease was defined as an increase in visible disease and/or presence of any new lesions, which were evaluated as per local guidelines by the clinician and were collected in the e-CRF. Kaplan-Meier method was used.	At 18 months from the date of palbociclib initiation in routine clinical practice
Percentage of Participants Who Were Progression Free at 24 Months Post Palbociclib Initiation Prazo: At 24 months from the date of palbociclib initiation in routine clinical practice	Percentage of participants who were progression free was defined as percentage of participants who were alive and for whom no progression of disease was reported. Progression of disease was defined as an increase in visible disease and/or presence of any new lesions, which were evaluated as per local guidelines by the clinician and were collected in the e-CRF. Kaplan-Meier method was used.	At 24 months from the date of palbociclib initiation in routine clinical practice
Percentage of Participants Who Were Alive at 1 Year Post Palbociclib Initiation Prazo: At 1 year from the date of palbociclib initiation in routine clinical practice	Percentage of participants who were alive at 1 year post palbociclib initiation were reported in this outcome measure.	At 1 year from the date of palbociclib initiation in routine clinical practice
Percentage of Participants Who Were Alive at 2 Years Post Palbociclib Initiation Prazo: At 2 year from the date of palbociclib initiation in routine clinical practice	Percentage of participants who were alive at 2 years post palbociclib initiation were reported in this outcome measure.	At 2 year from the date of palbociclib initiation in routine clinical practice

Medidas de resultados secundários

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Pfizer

Investigadores

Diretor de estudo: Pfizer CT.gov Call Center, Pfizer

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.

Links úteis

To obtain contact information for a study center near you, click here.

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)

15 de julho de 2021

Conclusão Primária (Real)

29 de abril de 2025

Conclusão do estudo (Real)

29 de abril de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

8 de junho de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de junho de 2021

Primeira postagem (Real)

24 de junho de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

A5481150
PRECIOUS (Outro identificador: Alias Study Number)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

A Pfizer fornecerá acesso a dados de participantes não identificados individuais e documentos de estudo relacionados (por exemplo, protocolo, Plano de Análise Estatística (SAP), Relatório de Estudo Clínico (CSR)) mediante solicitação de pesquisadores qualificados e sujeito a certos critérios, condições e exceções. Mais detalhes sobre os critérios de compartilhamento de dados da Pfizer e o processo de solicitação de acesso podem ser encontrados em: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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 .

Medida de resultado	Descrição da medida	Prazo
Objective Response Rate (ORR) Prazo: From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)	ORR was defined as the percentage of participants with an overall tumor response of complete response (CR) or partial response (PR) or stable disease. Complete response was defined as complete reduction of all visible disease; partial response was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease; stable disease was defined as no change in overall size of visible disease, also including cases where some lesions increased in size and some lesions decreased in size. The responses were evaluated as per local guidelines by the clinician and were collected in the e-CRF.	From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)
Time From Initial Breast Cancer Diagnosis to Recurrence of Breast Cancer Prazo: At baseline (prior to initiation of palbociclib treatment)	Data for time from initial breast cancer diagnosis to recurrence of breast cancer was collected at baseline from participants medical records.	At baseline (prior to initiation of palbociclib treatment)
Number of Participants According to Stage of Breast Cancer Prazo: At baseline (prior to initiation of palbociclib treatment)	Breast cancer stages included Stage I,IIA,IIB,IIIA,IIIB,IIIC as determined using Tumor Node Metastasis (TNM) classification system. Stage I: cancer is small and only in breast tissue or may be found in lymph nodes close to breast. Stage 2: there is cancer in breast or nearby lymph nodes or both. Stage IIA: no tumor found in breast, but cancer is found in one to three axillary lymph nodes, tumor measures 2 centimeter (cm) or smaller; IIB: tumor is larger than 2 cm. Stage 3: cancer is found in lymph nodes close to breast, skin of breast, or chest wall. Stage IIIA: any size tumor; spread to four to nine lymph nodes. Stage IIIB: any size tumor and has spread to chest wall and/or skin of breast and may have spread to up to nine axilliary lymph nodes or near breastbone. Stage IIIC: any size tumor and may have spread to chest wall or skin of breast and ten or more lymph nodes. Higher stage indicates more advanced disease.	At baseline (prior to initiation of palbociclib treatment)
Number of Participants According to Node Status Prazo: At baseline (prior to initiation of palbociclib treatment)	Number of participants classified according to node status were reported in this outcome measure. Node status included: N0, N1, N2, N3, NX. N0: there is no cancer in nearby lymph nodes, N1, N2 and N3: number and location of lymph nodes that contained cancer and NX: cancer is nearby lymph nodes cannot be measured.	At baseline (prior to initiation of palbociclib treatment)
Number of Participants According to Menopausal Status Prazo: At baseline (prior to initiation of palbociclib treatment)	Number of participants classified according to menopausal status were reported in this outcome measure. Menopausal status included: pre-menopausal and post-menopausal.	At baseline (prior to initiation of palbociclib treatment)
Number of Participants According to Prescribed Palbociclib Combination Prazo: At baseline (prior to initiation of palbociclib treatment)	Number of participants classified according to palbociclib combination prescribed (palbociclib plus letrozole/aromatase inhibitor and palbociclib plus fulvestrant) at palbociclib treatment initiation were reported in this outcome measure.	At baseline (prior to initiation of palbociclib treatment)
Number of Participants According to Sites of Metastases Prazo: At baseline (prior to initiation of palbociclib treatment)	Number of participants classified according to sites of metastases (visceral and non-visceral) were reported in this outcome measure.	At baseline (prior to initiation of palbociclib treatment)
Number of Participants According to Metastatic Status Prazo: At baseline (prior to initiation of palbociclib treatment)	Number of participants classified according to metastatic status (denovo advanced BC and recurrent/relapse advanced BC) were reported in this outcome measure.	At baseline (prior to initiation of palbociclib treatment)
Mean Weight of the Participants Prazo: At baseline (prior to initiation of palbociclib treatment)		At baseline (prior to initiation of palbociclib treatment)
Number of Participants Categorized According to Family History of Breast Cancer Prazo: At baseline (prior to initiation of palbociclib treatment)	Number of participants categorized according to family history of breast cancer (Yes/No) were reported in this outcome measure.	At baseline (prior to initiation of palbociclib treatment)
Number of Participants Categorized According to Treatment Schedule Prazo: From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)	Number of participants categorized according to treatment schedule of 3 weeks on, 1 week off (Yes) were reported in this outcome measure.	From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)
Number of Participants Categorized According to Palbociclib Dose Prazo: From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)	Number of participants categorized according to palbociclib dose (75 milligram [mg], 100 mg and 125 mg) were reported in this outcome measure.	From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)
Number of Participants Categorized According to Accompanying Endocrine Treatments Prazo: From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)	Number of participants categorized according to accompanying endocrine treatments were reported in this outcome measure. Accompanying endocrine treatments included: tamoxifen/NOLVADEX , toremifene / FARESTON, raloxifene / EVISTA, anastrozole / ARIMIDEX, letrozole / FEMARA, exemestane / AROMASIN, fulvestrant / FASLODEX, goserlin acetate / Zoaldex, leuprorelin /Lupron, triptorelin / Decapeptyl, degarelix / Firmagon. One participant may have received more than one endocrine treatment accompanying palbociclib treatment.	From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)
Number of Participants With Dose Interruption Prazo: From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)	Number of participants with palbociclib dose interruption were reported in this outcome measure.	From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)
Number of Participants With Dose Delays Prazo: From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)	Number of participants with dose delays were reported in this outcome measure.	From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)
Number of Participants Who Discontinued Palbociclib Treatment Prazo: From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)	Number of participants who discontinued palbociclib treatment were reported in this outcome measure.	From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)
Duration of Palbociclib Treatment Prazo: From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)	Duration of palbociclib treatment was defined as time (in days) from first to last day in palbociclib treatment.	From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)
Number of Participants According to Supportive Therapies Received During Palbociclib Combination Treatment Prazo: From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)	Number of participants according to supportive therapies received during palbociclib combination treatment were reported in this outcome measure. Supportive therapies included: zoledronic acid, calcium supplement, alfacalcidol, letrozole, vitamin D, gabapentin, tramadol, denosumab, granisetron, morphine, filgrastim, metoclopramide, dexamethasone, domperidone, duloxetine, fulvestrant, ondansetron, prednisolone, citalopram, itopride, oxycodone, pregabalin, sertraline. One participant may have received more than one supportive therapy.	From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)
Number of Participants Categorized According to Adjuvant Therapies Prazo: At baseline (prior to initiation of palbociclib treatment)	Number of participants categorized according to adjuvant therapies were reported in this outcome measure. Adjuvant therapies included: adjuvant chemotherapy, adjuvant hormonal therapy, experimental adjuvant therapy, neoadjuvant chemotherapy, neoadjuvant hormonal therapy, radiotherapy and surgery. One participant may have received more than one type of adjuvant therapy.	At baseline (prior to initiation of palbociclib treatment)
Time Between Start of Palbociclib Treatment and End of Adjuvant Therapy for Early/Locally Advanced Breast Cancer Prazo: At baseline (prior to initiation of palbociclib treatment)	Time between start of palbociclib treatment and end of therapy for early/locally advanced BC was calculated as date of initiation of palbociclib treatment - date of end of therapy for early/locally advanced therapy. Time between start of palbociclib treatment and end of adjuvant therapy for early/locally advanced breast cancer was collected at baseline from participant's medical records.	At baseline (prior to initiation of palbociclib treatment)
Number of Participants According to Therapies Received Before Palbociclib Treatment Prazo: At baseline (prior to initiation of palbociclib treatment)	Number of participants according to therapies received before palbociclib treatment were reported in this outcome measure. Therapies included: MBC chemotherapy, MBC hormonal therapy (other than Palbociclib combination), combination therapy, other therapy, radiotherapy and surgery. One participant may have received more than one type of therapy. Therapies for which non-zero data were available have been reported below.	At baseline (prior to initiation of palbociclib treatment)
Duration of Therapy for Treatment Received Before Palbociclib Treatment Prazo: At baseline (prior to initiation of palbociclib treatment)		At baseline (prior to initiation of palbociclib treatment)
Number of Participants According to First Subsequent Therapy Received After Palbociclib Treatment Discontinuation Prazo: From palbociclib treatment discontinuation until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)	Number of participants according to first subsequent therapy received after palbociclib treatment discontinuation were reported in this outcome measure. Subsequent therapies included systemic therapy, radiotherapy, surgery and other therapy. Subsequent therapies for which non-zero data were available have been reported below.	From palbociclib treatment discontinuation until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scale Scores Prazo: At 6, 12, 18 and 24 months post palbociclib treatment initiation	EORTC QLQ-30 included five functional scales (physical functioning, role, emotional, cognitive and social functioning), nine symptom scales (fatigue, nausea or vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties, and a global health status scale (GHS). The GHS/QoL scale ranged from 1=very poor to 7=excellent. All other items ranged from 1=not at all to 4=very much. A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS and functional scales, and 0 being the best and 100 being the worst for symptom scales.	At 6, 12, 18 and 24 months post palbociclib treatment initiation

Padrões de Tratamento e Resultados Clínicos das Combinações de Palbociclibe em HR+HER2-MBC (PRECIOUS)

Combinações de palbociclibe em pacientes com câncer de mama metastático HR+/HER2-: um estudo prospectivo não intervencional sobre os padrões de tratamento e resultados clínicos na África, Oriente Médio (PRECIOUS)