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GDF-15 y su relación con los eventos adversos relacionados con el tratamiento en el cáncer de mama (GRADE)

28 de septiembre de 2026 actualizado por: Breast Cancer Trials, Australia and New Zealand

Un estudio de cohorte prospectivo multicéntrico para explorar la relación entre los cambios en los niveles de GDF-15 y los eventos adversos relacionados con el tratamiento durante el tratamiento con T-DXd en pacientes con cáncer de mama.

GRADE is trying to find out if there is a link between a hormone called GDF-15 and the side effects that people can experience when taking T-DXd.

GDF-15 can be measured in the blood. GDF-15 levels in the blood will go up when the body is stressed under certain conditions, including breast cancer. There is a link between high GDF-15 levels and the nausea and vomiting experienced with "morning sickness" in pregnancy. It has also been shown that GDF-15 levels will go up with the use of other types of chemotherapy that are known to cause nausea and vomiting.

Side effects such as feeling sick (nausea), vomiting and weight loss are common with T-DXd. Sometimes, these can be so severe that treatment needs to be stopped early. The investigators can't predict who will get bad side effects and who will not.

If the investigators can find out if there is a link between GDF-15 and the side effects of T-DXd, they can use this information in future clinical trials.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

Growth differentiation factor 15 (GDF-15), a stress-related hormone also known as macrophage inhibitory cytokine-1 (MIC-1), is a member of the transforming growth factor-beta (TGF-β) superfamily. It is not expressed under basal conditions but can be released in response to pro-inflammatory conditions such as obesity, insulin resistance, renal and heart failure, and malignancy.

Pre-clinical studies have established the role of elevated GDF-15 levels in tumour and platinum-based chemotherapy induced emesis and cachexia. It has also been proposed as a biomarker for all-cause mortality, as well as for poor prognoses in patients with cancer.

The hypothesis is that there is a positive correlation between increased levels of GDF-15 and the severity of treatment-related adverse events (particularly nausea, vomiting and cachexia) experienced by patients with breast cancer receiving T-DXd.

The aim of the study is to explore the relationship between relative change in levels of GDF-15 from baseline (pre-treatment) to after receiving T-DXd (post-C2 and at end of treatment) and the severity of treatment-related adverse events experienced by patients with breast cancer receiving T-DXd.

If a positive relationship is found with any or all of these objectives, then monoclonal antibodies inhibiting GDF-15 (such as ponsegromab or visugromab) may present a promising therapeutic and supportive option for patients receiving T-DXd.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

150

Fase

  • No aplica

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

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Australia
    • New South Wales
      • Newcastle, New South Wales, Australia, 2290
        • Lake Macquarie Private Hospital
        • Contacto:
        • Investigador principal:
          • Nick Zdenkowski, Dr
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer Centre
        • Contacto:
        • Investigador principal:
          • Sherene Loi, Prof
  • Estados Unidos
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02215
        • Dana-Farber Cancer Institute
        • Contacto:
        • Investigador principal:
          • Michelle Li, Dr
  • Japón
      • Okayama, Japón, 700-8558
        • Okayama University Hospital
        • Contacto:
        • Investigador principal:
          • Tadahiko Shien, Prof

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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Participants aged ≥18 years.
  2. Histologically confirmed diagnosis of metastatic/advanced unresectable HER2-positive or HER2-low breast cancer.
  3. Planned to start treatment with T-DXd.
  4. Life expectancy of at least 4 months.

Exclusion Criteria:

  1. Current active reversible causes of decreased food intake, as determined by the Investigator.
  2. Receiving tube feedings or any kind of parenteral nutrition at the time of enrolment into the study.
  3. Ongoing cachexia attributable to other reasons unrelated to cancer or cancer treatment as determined by the Investigator that may confound interpretation of weight loss due to T-DXd.
  4. Current adherence to a calorie-restricted diet with the intention of weight loss.

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: Cuidados de apoyo
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: Blood Collection for GDF-15

Blood collection for GDF-15 during T-DXd treatment.
Otro: Blood collection for GDF-15

Blood samples of 20-30mL (approximately 1-2 tablespoons in total) will be taken 4 times:

  • Before first treatment with T-DXd
  • Two times during treatment (after the first and second doses of T-DXd); and
  • At the end of T-DXd treatment.

At each blood collection, participants will be asked about:

  • T-DXd side effects
  • Medications prescribe for T-DXd side effects
  • Weighed to see if their weight changes during treatment.

Personal and health information will also be collected from participants:

  • Date of birth and age, sex, ethnicity, height, weight, and activity levels.
  • Details about their cancer: diagnosis, type of cancer, other treatments, and pathology results.
  • Details about any previous pregnancies: how many, and the severity of any nausea or vomiting experienced during these pregnancies.
  • Details about their best response to treatment with T-DXd.
  • Details about the reason they stop T-DXd treatment.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Nausea prior to Cycle 3 of T-DXd, graded according to Common Terminology Criteria for Adverse Advents (CTCAE) v5.0.
Periodo de tiempo: From baseline to after receiving 2 cycles of T-DXd treatment (each cycle is 28 days).

To investigate if the percentage change in levels of GDF-15 from baseline to after receiving 2 cycles of T-DXd is associated with moderate/high grade nausea (CTCAE Grade 2-4) experienced at this timepoint by patients with metastatic/advanced unresectable HER2-positive or HER2-low breast cancer.
From baseline to after receiving 2 cycles of T-DXd treatment (each cycle is 28 days).

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Vomiting prior to Cycle 3 of T-DXd, graded as per CTCAE v5.0.
Periodo de tiempo: From baseline to after receiving 2 cycles of T-DXd treatment (each cycle is 28 days).

To investigate if the percentage change in levels of GDF-15 from baseline to after receiving 2 cycles of T-DXd is associated with moderate/high grade vomiting (CTCAE Grade 2-4) experienced by patients at this timepoint.
From baseline to after receiving 2 cycles of T-DXd treatment (each cycle is 28 days).
Weight loss (cachexia) prior to Cycle 3 of T-DXd, graded as per CTCAE v5.0.
Periodo de tiempo: From baseline to after receiving 2 cycles of T-DXd treatment (each cycle is 28 days).

To investigate if the percentage change in levels of GDF-15 from baseline to after receiving 2 cycles of T-DXd is associated with moderate/high grade cachexia (CTCAE Grade 2-4) experienced by patients at this timepoint.
From baseline to after receiving 2 cycles of T-DXd treatment (each cycle is 28 days).
Percentage change in GDF-15 and its correlation with treatment-related adverse events (TRAEs)
Periodo de tiempo: From baseline to after receiving 2 cycles of T-DXd treatment (each cycle is 28 days).

To explore the correlation of the percentage change in levels of GDF-15 with the treatment-related adverse events (CTCAE Grade 2-4). Treatment-related adverse events (TRAEs) are adverse events classified as possibly, probably or definitely related to T-DXd treatment. TRAEs will be graded as per CTCAE v5.0.
From baseline to after receiving 2 cycles of T-DXd treatment (each cycle is 28 days).
Progression-free survival (PFS)
Periodo de tiempo: Time from treatment start with T-DXd to the first occurrence of disease progression or death due to any cause, whichever came first, assessed up to 6 months.

To explore the relationship between baseline levels of GDF-15 and progression-free survival (PFS) on T-DXd
Time from treatment start with T-DXd to the first occurrence of disease progression or death due to any cause, whichever came first, assessed up to 6 months.
Time to treatment failure (TTF)
Periodo de tiempo: Time from treatment start with T-DXd to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death, whichever came first, assessed up to 6 months.

To explore the relationship between baseline levels of GDF-15 and time to treatment failure (TTF) on T-DXd.
Time from treatment start with T-DXd to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death, whichever came first, assessed up to 6 months.
HER2 copy number
Periodo de tiempo: Prior to treatment commencement.

To explore the relationship between HER2 copy number and change in levels of GDF-15. HER2 copy number determined by in-situ hybridization (ISH) on most recent available histopathology specimen or tumour/plasma genomic data (DNA/RNA), preferably in the metastatic setting
Prior to treatment commencement.

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Exploratory: Association of baseline levels of GDF-15 with Treatment Related Adverse Events (TRAEs).
Periodo de tiempo: TRAEs occurring after Cycle 2, after Cycle 3 and within 30 days of end of treatment with T-DXd (each cycle is 28 days).

To explore if baseline levels of GDF-15 are associated with the incidence and severity of TRAEs experienced by patients on T-DXd, graded as per CTCAE v5.0.
TRAEs occurring after Cycle 2, after Cycle 3 and within 30 days of end of treatment with T-DXd (each cycle is 28 days).
Exploratory: Longitudinal change in weight after 2 cycles of T-DXd
Periodo de tiempo: After receiving 2 cycles of T-DXd (each cycle is 28 days).

To explore if the longitudinal change in levels of GDF-15 from baseline to after receiving 2 cycles of T-DXd is associated with trends in weight change. Weight change is measured as a percentage of baseline weight. End-of-treatment is defined as cessation of treatment due to disease progression or treatment toxicity.
After receiving 2 cycles of T-DXd (each cycle is 28 days).
Exploratory: Longitudinal change in weight at end-of-treatment
Periodo de tiempo: At end-of-treatment with T-DXd; end-of-treatment is defined as cessation of treatment due to disease progression or treatment toxicity, whichever came first, assessed up to 6 months.

To explore if the longitudinal change in levels of GDF-15 from baseline at end-of-treatment with T-DXd is associated with trends in weight change. Weight change is measured as a percentage of baseline weight.
At end-of-treatment with T-DXd; end-of-treatment is defined as cessation of treatment due to disease progression or treatment toxicity, whichever came first, assessed up to 6 months.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Breast Cancer Trials, Australia and New Zealand

Investigadores

  • Director de estudio: Heath Badger, Breast Cancer Trials, Australia and New Zealand
  • Silla de estudio: Sherene Loi, Prof, Peter MacCallum Cancer Centre, Australia
  • Silla de estudio: Michelle Li, Dr, Peter MacCallum Cancer Centre, Australia

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.

Enlaces Útiles

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)

1 de octubre de 2026

Finalización primaria (Estimado)

1 de octubre de 2028

Finalización del estudio (Estimado)

1 de octubre de 2028

Fechas de registro del estudio

Enviado por primera vez

26 de febrero de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de marzo de 2026

Publicado por primera vez (Actual)

11 de marzo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

28 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • BCT 2502

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Anonymised Individual Patient Data (IPD) collected during the trial.

Marco de tiempo para compartir IPD

Data will be made available for request after publication of the main/final study results; no end date.

Criterios de acceso compartido de IPD

Researchers who submit a research proposal and BCT Data Request Application, which is assessed by BCT to have appropriate scientific value. Applications will be subject to approval by Breast Cancer Trials concept@bctrials.org.au (refer to BCT Data Sharing Guidelines).

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • CÓDIGO_ANALÍTICO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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