A Study of Tersolisib (LY4064809) and Abemaciclib With Hormone Therapies in Participants With PIK3CA-Mutated Early Breast Cancer (PIKALO-3)
A Phase 2, Open-label, Randomized Study Investigating the Tolerability of Concurrent Versus Staggered Administration of Abemaciclib and Endocrine Therapy With Tersolisib in Patients With HR+, HER2- Node-Positive, PIK3CA-Mutated Early Breast Cancer.
The main purpose of this study is to compare two ways of giving the anti-cancer medicines abemaciclib and hormone therapy with tersolisib in participants with early breast cancer that has a genetic mutation (PIK3CA mutation).
For each participant, the study will last up to 56 weeks and include 12 visits.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
Contactos e Locais
Contato de estudo
- Nome: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Número de telefone: 1-317-615-4559
- E-mail: LillyTrials@Lilly.com
Estude backup de contato
- Nome: Physicians interested in becoming principal investigators please contact
- E-mail: clinical_inquiry_hub@lilly.com
Locais de estudo
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California
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Los Alamitos, California, Estados Unidos, 90720
- Cancer and Blood Specialty Clinic
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Investigador principal:
- Sassan Farjami
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Colorado
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Lakewood, Colorado, Estados Unidos, 80228
- USO - Rocky Mountain Cancer Centers
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Investigador principal:
- Sara Robinson
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Georgia
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Atlanta, Georgia, Estados Unidos, 30308
- Winship Cancer Institute, Emory University
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Investigador principal:
- Manali Bhave
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Dana-Farber Cancer Institute
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Investigador principal:
- Erica Mayer
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Ohio
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Columbus, Ohio, Estados Unidos, 43212
- Stefanie Spielman Comprehensive Breast Center
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Investigador principal:
- Robert Wesolowski
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Texas
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Amarillo, Texas, Estados Unidos, 79106
- Texas Oncology - West Texas
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Investigador principal:
- Ines Sanchez-Rivera
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Austin, Texas, Estados Unidos, 78731
- Texas Oncology - Balcones
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Investigador principal:
- Kathryn Hudson
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San Antonio, Texas, Estados Unidos, 78229-3307
- South Texas Accelerated Research Therapeutics (START)
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Investigador principal:
- Amita Patnaik
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Virginia
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Reston, Virginia, Estados Unidos, 20190
- USO - Virginia Cancer Specialists
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Investigador principal:
- Isabelle Le
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
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Have histologically or cytologically confirmed breast cancer, defined as individuals with:
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early stage, resected, invasive breast cancer without evidence of distant metastasis, and
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have confirmed hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) status defined by
- Hormone Receptor (HR) status: documented estrogen receptor positive (ER+) and/or progesterone receptor+ tumor, defined as greater than or equal to (≥) 1% of tumor cells stained positive, assessed locally on primary disease specimen, as defined by American Society of Clinical Oncology College of American Pathologists (ASCO/CAP) Guidelines
- HER status: fulfill the requirement of HER2- disease by local testing on primary disease specimen; tumor must be HER2- according to ASCO/CAP guidelines for HER2 testing
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Have evidence of an activating phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA) mutation in tumor tissue.
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Must have undergone definitive locoregional therapy, defined as surgery of the primary breast tumor(s), with or without radiation therapy, and/or systemic therapy (neo/adjuvant chemotherapy and or Endocrine Therapy (ET)) per standard guidelines.
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Individuals with bilateral breast cancer (diagnosis of invasive tumors in both breasts simultaneously or within 6 months of each other) may be eligible if all lesions tested on both sides are HR+ HER2- and adequate surgery has been performed for both breasts.
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Tumor involvement in at least 1 axillary lymph node (ALN).
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≥ ipsilateral positive ALN, OR
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1 to 3 ipsilateral positive ALN and either:
- tumor size ≥5cm, or
- histologic Grade 3 tumor (as defined by a combined score of at least 8 points per the modified Bloom-Richardson grading system or equivalent
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Individuals must be randomized within 16 months from the time of definitive breast cancer surgery.
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May have received up to 12 weeks of ET with AIs or tamoxifen until randomization following the last non-ET (surgery, chemotherapy, or radiation), whichever is last.
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Are willing to follow contraception requirements.
Exclusion Criteria:
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Have evidence of
- metastatic disease
- inflammatory breast cancer at primary breast cancer diagnosis
- breast cancer recurrence (local, regional, or distant), or
- a history of previous invasive breast cancer
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Has an established diagnosis of type 1 diabetes mellitus or type 2 diabetes mellitus with Hemoglobin A1c (HbA1c) ≥8 percent (%), fasting plasma glucose ≥140 mg/dL (7.7 mmol/L), or requiring insulin.
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Has a history of malignancy other than breast cancer
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Have active Hepatitis B Virus (HBV)
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Have active Hepatitis C Virus (HCV)
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Have untreated Human Immunodeficiency Virus (HIV) infection
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Have any other active systemic infection requiring system therapy
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Have a history of Kaposi sarcoma or multicentric Castleman disease
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Have a serious cardiac condition
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 |
|---|---|
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Experimental: Arm A: Abemaciclib and Endocrine Therapy (ET) + Tersolisib - Staggered
Abemaciclib in combination with physician's choice of endocrine therapy (ET). Tersolisib will be added in a staggered approach after 2 cycles of abemaciclib and ET. All drugs will be administered orally. |
Administered orally Administered orally Administered orally Administered orally Administered orally
Outros nomes:
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Experimental: Arm B: Abemaciclib and Endocrine Therapy (ET) + Tersolisib - Concurrent
Abemaciclib and tersolisib will be administered concurrently in combination with physician's choice of ET. All drugs will be administered orally. |
Administered orally Administered orally Administered orally Administered orally Administered orally
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Rate of Participants who Discontinue Tersolisib Due to Treatment Emergent Adverse Events (TEAEs).
Prazo: Cycle 1 through study completion (estimated as 56 weeks)
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Cycle 1 through study completion (estimated as 56 weeks)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Duration of Exposure to Study Intervention
Prazo: Start of study intervention through study completion (estimated as 56 weeks)
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Study intervention start is defined as Cycle -1 for Arm A and Cycle 1 for Arm B. Arm A includes an additional 8 weeks. |
Start of study intervention through study completion (estimated as 56 weeks)
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Number of Study Intervention Dose Adjustments
Prazo: Start of study intervention through study completion (estimated as 56 weeks)
|
Study intervention start is defined as Cycle -1 for Arm A and Cycle 1 for Arm B. Arm A includes an additional 8 weeks. |
Start of study intervention through study completion (estimated as 56 weeks)
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Pharmacokinetics (PK): Predose Plasma Concentrations (Cmax) of Tersolisib
Prazo: Day 15 through study completion (estimated as 56 weeks)
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Day 15 through study completion (estimated as 56 weeks)
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Change from Baseline in Side-Effect Burden as Measured by Functional Assessment of Cancer Therapy - General Item GP5 (FACT-GP5)
Prazo: Baseline to end of study completion (estimated as 56 weeks)
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Baseline to end of study completion (estimated as 56 weeks)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
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
- 27842
- 2026-526410-87-00 (Ctis)
- J6M-MC-JSGH (Outro identificador: Eli Lilly and Company)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Prazo de Compartilhamento de IPD
Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Critérios de acesso de compartilhamento IPD
A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CSR
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