A Study to Learn How Well Participants With a Specific Type of Early Breast Cancer (ER-Positive, HER2-Negative) Tolerate and Stay on Treatment With Giredestrant and How They Feel During Treatment (kalitERA)
15 de septiembre de 2026 actualizado por: Hoffmann-La Roche
A Phase IIIb, Single-arm, Open-Label, Multicenter Study Evaluating the Treatment Adherence, Tolerability, and Patient-Reported Outcomes of Giredestrant in Patients With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer
The purpose of this study is to evaluate treatment adherence, tolerability, and patient-reported outcomes of participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (eBC) who are treated with giredestrant.
The study will have two cohorts. Cohort A will comprise a broad upfront patient population with low-, medium-, or high-risk eBC. Cohort B will comprise patients with medium- or high-risk eBC who have completed adjuvant treatment with cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) (abemaciclib or ribociclib) and endocrine therapy and who are now switching to giredestrant monotherapy.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
1500
Fase
- Fase 3
Acceso ampliado
Disponible fuera del ensayo clínico.
Ver registro de acceso ampliado.
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Copia de seguridad de contactos de estudio
- Nombre: Reference Study ID Number: BO46775 https://forpatients.roche.com/ No attachments to email below.
- Número de teléfono: 888-662-6728 (U.S. Only)
- Correo electrónico: global-roche-genentech-trials@gene.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Histologically confirmed diagnosis of ER-positive, HER2-negative, Stage I-III, breast cancer
- Definitive surgery of primary breast tumor(s) and axillary lymph nodes (axillary lymph node dissection and/or sentinel lymph node biopsy)
- Participants must have completed any prior adjuvant chemotherapy before enrollment, if given
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2
- Adequate organ function
- Men and pre- or perimenopausal women must receive a concurrent approved luteinizing hormone-releasing hormone agonist
Exclusion Criteria:
- Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required
- Diagnosis of inoperable locally advanced or Stage IV breast cancer
- History of any prior (ipsilateral and/or contralateral) invasive breast cancer or ductal carcinoma in situ (DCIS)
- Planned surgery during the study
- Prior treatment with giredestrant, selective estrogen receptor degraders (SERDs), or investigational endocrine agents
- Active cardiac disease or history of cardiac dysfunction
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Cohort A: Upfront Adjuvant Endocrine Therapy Population
Participants will receive giredestrant.
|
Participants will receive giredestrant 30 mg orally once a day for up to 5 years.
Otros nombres:
|
|
Experimental: Cohort B: Switch Adjuvant Endocrine Therapy Population
Participants will receive giredestrant.
|
Participants will receive giredestrant 30 mg orally once a day for up to 5 years.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Incidence of Participants who Have Discontinued Giredestrant for any Reason
Periodo de tiempo: Month 12
|
Month 12
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Incidence and Severity of Adverse Events (AEs)
Periodo de tiempo: Up to approximately 5 years
|
Up to approximately 5 years
|
|
Treatment Adherence, as Measured by Dose Intensity
Periodo de tiempo: Up to approximately 5 years
|
Up to approximately 5 years
|
|
Treatment Adherence, as Measured by Treatment Duration
Periodo de tiempo: Up to approximately 5 years
|
Up to approximately 5 years
|
|
Cohort A: Mean Absolute Score for Joint Pain as Assessed by Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES)
Periodo de tiempo: At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in Joint Pain Score as Assessed by FACT-ES
Periodo de tiempo: At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Absolute Score for Hot Flashes as Assessed by FACT-ES
Periodo de tiempo: At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in Hot Flashes Score as Assessed by FACT-ES
Periodo de tiempo: At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Absolute Score for Vaginal Dryness as Assessed by FACT-ES
Periodo de tiempo: At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in Vaginal Dryness Score as Assessed by FACT-ES
Periodo de tiempo: At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Absolute Score for Sexual Dysfunction as Assessed by FACT-ES
Periodo de tiempo: At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in Sexual Dysfunction Score as Assessed by FACT-ES
Periodo de tiempo: At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Absolute Score for the Overall Endocrine Symptom Burden as Assessed by FACT-ES Endocrine Symptom Subscale Score
Periodo de tiempo: At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in the Overall Endocrine Symptom Burden Score as Assessed by FACT-ES Endocrine Symptom Subscale Score
Periodo de tiempo: At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Absolute Score for Pain as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Pain Severity Composite Score
Periodo de tiempo: At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in Pain as Assessed by the BPI-SF Pain Severity Composite Score
Periodo de tiempo: At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Absolute Score for Pain Interference as Assessed by the BPI-SF Pain Interference Composite Score
Periodo de tiempo: At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in Pain Interference as Assessed by the BPI-SF Pain Interference Composite Score
Periodo de tiempo: At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Percentage of Participants Reporting Each Response Option for the Treatment Side-Effect Bother Single-Item GP5 (General Physical Well-Being Item 5) as Assessed by the Functional Assessment of Cancer Therapy-General (FACT-G)
Periodo de tiempo: At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Change From Baseline in the Treatment Side-Effect Bother Single-Item GP5 as Assessed by FACT-G
Periodo de tiempo: At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort B: Percentage of Participants Achieving Improvement in Joint Pain Score as Assessed by FACT-ES
Periodo de tiempo: Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort B: Percentage of Participants Achieving Improvement in Hot Flashes Score as Assessed by FACT-ES
Periodo de tiempo: Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort B: Percentage of Participants Achieving Improvement in Vaginal Dryness Score as Assessed by FACT-ES
Periodo de tiempo: Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort B: Percentage of Participants Achieving Improvement in Sexual Dysfunction Score as Assessed by FACT-ES
Periodo de tiempo: Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Endocrine Therapy-Specific Symptom Burden as Assessed by the FACT-ES Endocrine Symptom Subscale Score
Periodo de tiempo: Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Pain-Related Burden as Assessed by the BPI-SF Pain Severity Composite Score
Periodo de tiempo: Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Pain-Related Burden as Assessed by the BPI-SF Pain Interference Composite Score
Periodo de tiempo: Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort B: Percentage of Participants Achieving Improvement in Global Treatment Bother as Assessed by the Single-Item GP5 From the FACT-G
Periodo de tiempo: Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort A: Mean Absolute Score for Physical Function as Assessed by the European Organization for Research and Treatment of Cancer Item Library 492 (EORTC IL 492)
Periodo de tiempo: At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in Physical Function Score as Assessed by EORTC IL 492
Periodo de tiempo: At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Absolute Score for Role Function as Assessed by EORTC IL 492
Periodo de tiempo: At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in Role Function Score as Assessed by EORTC IL 492
Periodo de tiempo: At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Absolute Score for Cognitive Function as Assessed by EORTC IL 492
Periodo de tiempo: At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in Cognitive Function Score as Assessed by EORTC IL 492
Periodo de tiempo: At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Absolute Score for Health-Related Quality of Life (HRQoL) as Assessed by EORTC IL 492
Periodo de tiempo: At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in HRQoL Score as Assessed by EORTC IL 492
Periodo de tiempo: At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Physical Function as Assessed by EORTC IL 492
Periodo de tiempo: Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Role Function as Assessed by EORTC IL 492
Periodo de tiempo: Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Cognitive Function as Assessed by EORTC IL 492 Subscale Score
Periodo de tiempo: Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in HRQoL as Assessed by EORTC IL 492 Subscale Score
Periodo de tiempo: Month 6 and Month 12
|
Month 6 and Month 12
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Clinical Trials, Hoffmann-La Roche
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
30 de octubre de 2026
Finalización primaria (Estimado)
30 de noviembre de 2028
Finalización del estudio (Estimado)
30 de noviembre de 2032
Fechas de registro del estudio
Enviado por primera vez
15 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
15 de septiembre de 2026
Publicado por primera vez (Actual)
18 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
15 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BO46775
- 2026-526742-27-00 (Ctis)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
For eligible studies, qualified researchers may request access to individual patient level clinical data.
See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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