A Study of a Medicine Called Atirmociclib in Combination With Giredestrant in Adult Participants With ER-positive, HER2-negative Early-stage Breast Cancer
AN INTERVENTIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, RANDOMIZED, MULTICENTER PHASE 3 STUDY OF ATIRMOCICLIB (PF-07220060) PLUS GIREDESTRANT COMPARED TO GIREDESTRANT MONOTHERAPY AS ADJUVANT TREATMENT IN ADULT PARTICIPANTS WITH ESTROGEN RECEPTOR (ER)-POSITIVE, HER2-NEGATIVE EARLY-STAGE BREAST CANCER WITH MEDIUM OR HIGH RISK OF RECURRENCE (FOURLIGHT-4)
This Phase 3 study will evaluate whether atirmociclib plus giredestrant improves invasive breast cancer-free survival compared with giredestrant alone in adults with ER-positive, HER2-negative early breast cancer at medium or high risk of recurrence.
This is a Phase 3, double blind, placebo controlled study of atirmociclib plus giredestrant vs. giredestrant monotherapy as adjuvant treatment in adult patients with ER+, HER2- early breast cancer. The study plans to enroll 3800 participants randomized 1:1 into one of two treatment arms (Arm A - investigational: atirmociclib plus giredestrant taken continuously in a 28-day cycle) or (Arm B - comparator: placebo plus giredestrant taken continuously in a 28-day cycle). Participants may be treated with atirmociclib/placebo up to 3 years and giredestrant up to 5 years followed by long term follow up for survival and evaluation of recurrence of disease.
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Tipo de estudo
Tipo de estudo
Inscrição (Estimado)
Inscrição
Estágio
Estágio
- Fase 3
Contactos e Locais
Contato de estudo
Contato de estudo
- Nome: Pfizer CT.gov Call Center
- Número de telefone: 1-800-718-1021
- E-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
KEY INCLUSION CRITERIA
-
Histologically confirmed unilateral primary adenocarcinoma of the breast
- ER-positive by local assessment
- documented HER2-negative
-
Node positive or node negative as defined by:
-
Pathological node positive (microscopic and/or macroscopic tumor involvement >/=pN1)
-
pN0 and pT >1cm with at least one of the following:
- pT4N0 or
- histologically Grade 3 disease or
- high-risk classification based on genomic assay
-
-
Randomization within 16 months of definitive breast surgery
-
If indicated, completed adjuvant and/or neoadjuvant chemotherapy, adjuvant radiation therapy >/= 21 days prior to randomization
KEY EXCLUSION CRITERIA
-
Distant metastases of breast cancer beyond regional lymph nodes
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Multicentric or multifocal breast cancer if any tumor foci meet pathologic criteria for ER(-) or HER2(+)
-
Clinically significant cardiovascular disease or cardiac repolarization abnormality for 6 months prior to randomization; resting heart rate <50bpm
-
Has received the following prior systemic anti-cancer therapy for breast cancer
- prior atirmociclib, giredestrant, other investigational anti-cancer agent
- prior treatment with olaparib
NOTES:
- short course of prior neo/adjuvant CDK4/6 inhibitor treatment (</=8 weeks) is permitted; 10-day washout period required
- short course of prior neoadjuvant and/or adjuvant ET (</=18 weeks) is permitted; 35-day washout period for tamoxifen is required
-
Prior treatment with investigational product within 30 days or 5 half-lives
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Número de braços
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
|
Experimental: Arm A : Atirmociclib + giredestrant
Atirmociclib tablet given orally twice daily, plus giredestrant capsule given orally once per day |
Atirmociclib tablet given orally twice daily, plus giredestrant capsule given orally once per day
Outros nomes:
giredestrant capsule given once a day |
|
Comparador Ativo: Arm B: Placebo for atirmociclib + giredestrant
Placebo atirmociclib tablets given orally twice a day plus giredestrant capsule given once a day |
giredestrant capsule given once a day Atirmociclib placebo tablet given twice a day |
O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Invasive Breast Cancer Free Survival (iBCFS)
Prazo: From randomization to first iBCFS event, up to 16 years
|
iBCFS is defined as the time from the date of randomization to the date of first documented occurrence of invasive ipsilateral breast tumor recurrence, local-regional invasive breast cancer recurrence, invasive contralateral breast cancer, distant recurrence, or death from any cause, as determined by investigator assessment per STEEP v2.0 criteria |
From randomization to first iBCFS event, up to 16 years
|
Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Invasive Disease Free Survival (iDFS)
Prazo: From randomization to first iDCFS event, up to 16 years
|
iDFS defined as the time from the date of randomization to the date of first documented occurrence of invasive ipsilateral breast tumor recurrence, local-regional invasive breast cancer recurrence, invasive contralateral breast cancer, distant recurrence, second primary invasive non-breast cancer, or death from any cause, as determined by investigator assessment per STEEP v2.0 criteria |
From randomization to first iDCFS event, up to 16 years
|
|
Disease Recurrence Free Survival (DRFS)
Prazo: From randomization to first DRFS event, up to 16 years
|
DRFS as per investigator assessment, defined as the time from the date of randomization to the date of distant recurrence as determined by investigator assessment or death from any cause, whichever occurs first |
From randomization to first DRFS event, up to 16 years
|
|
Overall survival (OS)
Prazo: From randomization to death from any cause, up to 16 years
|
OS is defined as the time from the date of randomization to the date of death due to any cause |
From randomization to death from any cause, up to 16 years
|
|
Number and percentage of Participants with Treatment-Emergent Adverse Events (AEs)
Prazo: From start of treatment until 28 days after last dose of study treatment, up to 5 years
|
Type, incidence, severity of AE graded by NCI CTCAE v 5.0, seriousness and relationship to study intervention |
From start of treatment until 28 days after last dose of study treatment, up to 5 years
|
|
Percentage of participants With Clinical Laboratory Abnormalities
Prazo: From start of treatment until 28 days after last dose of study treatment, up to 5 years
|
From start of treatment until 28 days after last dose of study treatment, up to 5 years
|
|
|
Percentage of Participants With ECG abnormalities
Prazo: From start of treatment until 28 days after last dose of study treatment, up to 5 years
|
From start of treatment until 28 days after last dose of study treatment, up to 5 years
|
|
|
Patient Reported Outcomes (PRO)
Prazo: From start of treatment until 28 days after last dose of study treatment, up to 5 years
|
Change from baseline in participant reported total score, well-being subscales and symptoms scores and TOI per FACT-ES |
From start of treatment until 28 days after last dose of study treatment, up to 5 years
|
|
Pre-dose Plasma Concentration (Ctrough) of atirmociclib
Prazo: Cycle 1 Day 15, Cycle 2 Day 1, and Cycle 3 Day 1; Cycle is defined as 28 days
|
Cycle 1 Day 15, Cycle 2 Day 1, and Cycle 3 Day 1; Cycle is defined as 28 days
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Diretor de estudo: Pfizer CT.gov Call Center, Pfizer
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Início do estudo
Conclusão Primária (Estimado)
Conclusão Primária
Conclusão do estudo (Estimado)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
Outros números de identificação do estudo
- C4391026
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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