Local Treatment in ER-positive/HER2-negative Oligo-metastatic Breast Cancer

Local Treatment in Addition to Endocrine Therapy in ER-positive/HER2-negative Oligo-metastatic Breast Cancer (CLEAR): a Multicentre, Single -Arm, Phase 2 Trial

Patrocinadores

Patrocinador principal: Gangnam Severance Hospital

Colaborador: Severance Hospital
Samsung Medical Center
Asan Medical Center

Fuente Gangnam Severance Hospital
Resumen breve

Local treatment in addition to endocrine treatment as 1st line for oligo-metastatic ER-positive/HER2-negative breast cancer.

Descripción detallada

Local treatment included surgical resection, stereotactic body radiotherapy, palliative radiotherapy, and radiofrequency ablation. Stereotactic body radiotherapy is preferred as a radiation modality.

Endocrine therapies with/without target therapy including CDK4/6 inhibitors or mTOR inhibitors are the mainstay of 1st line treatment for ER-positive/HER2-negative metastatic breast cancer.

Estado general Recruiting
Fecha de inicio August 1, 2018
Fecha de Terminación July 31, 2025
Fecha de finalización primaria July 31, 2021
Fase Phase 2
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Progression-free survival From the date of registration to the date of first PFS failure or last follow-up; assessed up to 6 years; Median PFS of all registered patients will be over 30 months
Resultado secundario
Medida Periodo de tiempo
Overall survival From the date of registration to the date of death or last follow-up; assessed up to 10 years
Inscripción 110
Condición
Intervención

Tipo de intervención: Procedure

Nombre de intervención: Surgical resection

Descripción: Surgical resection for their metastatic lesions will be performed. Achievement of tumor-free margin is not mandatory.

Etiqueta de grupo de brazo: Endocrine and local treatments

Tipo de intervención: Radiation

Nombre de intervención: Stereotactic body radiotherapy

Descripción: Deliver appropriate metastasis directed radiotherapy while minimizing exposure of surrounding normal tissues. Total radiation dose and fractions are various according to metastatic lesions (57~97.5Gy/6~10 Fraction).

Etiqueta de grupo de brazo: Endocrine and local treatments

Otro nombre: SBRT

Tipo de intervención: Procedure

Nombre de intervención: Radiofrequency ablation

Descripción: RFA is a localized thermal treatment technique designed to induce tumor destruction by heating the tumor tissue to temperatures that exceed 60℃. The alternating current of radiofrequency waves passing down from an uninsulated electrode tip into the surrounding tissues generates changes in the direction of ions and creates ionic agitation and frictional heating. This tissue heating then drives extracellular and intracellular water out of the tissue, resulting in tissue destruction by coagulative necrosis.

Etiqueta de grupo de brazo: Endocrine and local treatments

Otro nombre: RFA

Elegibilidad

Criterios:

Inclusion Criteria:

-ER-positive/HER2-negative in primary tumor

- Oligometastases: ≤ 2 lesions in single organ or site (lung, bone, liver, adrenal glands, distant LNs)

- Recurrent cancer after completion of primary treatment (RFI≥1year)

- Metastatic lesions are feasible for resection or radiotherapy (Size≤3cm)

Exclusion Criteria:

- De Novo metastatic cancer at initial diganosis

- Recurrence-free inverval < 1 year

Género: Female

Basado en el género: Yes

Descripción de género: Biologically woman

Edad mínima: 20 Years

Edad máxima: 75 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Joon Jeong, Ph.D. Principal Investigator Gangnam Severance Hospital
Contacto general

Apellido: Sung Gwe Ahn, Ph.D.

Teléfono: 82-2-2019-4402

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Copia de seguridad de contactos: Gangnam Severance Hospital Joon Jeong, M.D.,Ph.D. 82220193370 [email protected]
Ubicacion Paises

Korea, Republic of

Fecha de verificación

February 2019

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Gangnam Severance Hospital

Nombre completo del investigador: Joon Jeong

Título del investigador: Professor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 1
Grupo de brazo

Etiqueta: Endocrine and local treatments

Tipo: Experimental

Descripción: Endocrine therapy is a standard-of-care for 1st line treatment in the patients with ER+/HER2- metastatic breast cancer. Endocrine options included aromatase inhibitors, aromatase inhibitors with CDK4/6 inhibitors, fulvestrant, fulvestrant with CDK4/6 inhibitors, everolimus with exemestane, tamoxifen. For premenopausal women, agents for ovarian function suppression using GnRH agonists or surgical ovarian ablation including bilateral salpingo-oophorectomy are allowed. Local treatments for metastatic lesions will be added in this group. Local treatments include modalities described below: i) Surgical resection: the achievement of tumor-free margin is not obligatory. ii) Stereotactic body radiotherapy iii) Radiofrequency ablation

Acrónimo CLEAR
Información de diseño del estudio

Asignación: N/A

Modelo de intervención: Single Group Assignment

Descripción del modelo de intervención: Endocrine therapy is a standard-of-care for 1st line treatment in the patients with ER+/HER2- metastatic breast cancer. Local treatments for metastatic lesions will be added in this group. All patients will undergo local treatments in addition to endocrine therapies. Local treatments include modalities described below: i) Surgical resection: the achievement of tumor-free margin is not obligatory. ii) Stereotactic body radiotherapy iii) Radiofrequency ablation

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov