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Un estudio que compara el uso de GDC-9545 con la terapia hormonal elegida por el médico en personas con cáncer de mama avanzado o metastásico, cuyo tratamiento previo no haya funcionado.
Un estudio que evalúa la eficacia y la seguridad del giredestrant en comparación con la monoterapia endocrina elegida por el médico en pacientes con cáncer de mama metastásico o localmente avanzado, HER2 negativo con receptor de estrógeno positivo tratados previamente
- Cáncer
- Cáncer de mama
- Cáncer de mama Er-positivo
- Cáncer de mama Her-2 negativo
- Cáncer de mama localmente avanzado o metastásico
- Receptor estrogénico (RE) positivo
Tenga en cuenta que el estado de reclutamiento del estudio clínico en su centro puede diferir del estado general del estudio debido a que algunos centros del estudio pueden llevar a cabo el reclutamiento antes que otros.
Estado del estudio:
Activo, no reclutando
Este estudio clínico se lleva a cabo en
Ciudades
- ABD
- Ankara
- Antalya
- Aschaffenburg
- ashdod
- Ashland
- Austin
- Berlín
- Białystok
- Billings
- Bloemfontein
- Buenos Aires
- Ceará
- Chang Wat Chiang Mai
- chang-chun-shi
- Changhua County
- Cheonan
- Cleveland
- Darlinghurst
- Diyarbakır
- Eastleigh
- El Paso
- Esmirna
- Gliwice
- Goyang-si
- gqeberha
- guang-zhou-shi
- Hamburgo
- hang-zhou-shi
- Harbin
- Harlow
- Houston
- İstanbul
- Jerusalem
- Kazán
- Kefar Sava
- Krasnodar
- Krung Thep Maha Nakhon
- Kyiv
- linyi
- London
- Marietta
- Mendoza
- nan-chang-shi
- Niles
- Nizhni Nóvgorod
- Nottingham
- Paderborn
- Peterborough
- Portland
- Rio Grande do Sul
- Rosario
- Saint Albans
- Samara
- Samsun
- San Petersburgo
- Sankt-Peterburg
- Seoul
- Shanghai
- Singapore
- Stralsund
- Sumy
- São Paulo
- Tainan City
- Taipei City
- tambon-kho-hong
- tian-jin-shi
- Tyler
- volgograd
- Warszawa
- wu-han-shi
- xi-an-shi
- Yaroslavl
- Yitomir
- Óblast de Moscú
Identificador del Ensayo:
NCT04576455 2020-001984-10 RENIS IS003742 WO42312
Resumen del estudio
This Phase II, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant compared with physician's choice of endocrine monotherapy in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have received one or two prior lines of systemic therapy in the locally advanced or metastatic setting.
Hoffmann-La Roche
Patrocinador
Fase 2
Fase
NCT04576455, WO42312, 2020-001984-10, RENIS IS003742
Identificador del Ensayo
Giredestrant, Fulvestrant or an Aromatase Inhibitor (Physician Choice), LHRH Agonist
Tratamientos
Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
Afección
Título Oficial
A Phase II, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Compared With Physician's Choice of Endocrine Monotherapy in Patients With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
Criterios de selección
Todos
Género
≥18 Años
Edad
No
Voluntarios sanos
Criterios de Inclusión
- Women who are postmenopausal or premenopausal/perimenopausal
- For women who are premenopausal or perimenopausal and for men: willing to undergo and maintain treatment with approved LHRH agonist therapy for the duration of study treatment
- Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
- Documented ER-positive tumor and HER2-negative tumor, assessed locally
- Disease progression after treatment with one or two lines of systemic therapy (but not more than one prior targeted therapy) in the locally advanced or metastatic setting
- Measurable disease as defined per RECIST v.1.1 or bone only disease which must have at least one predominantly lytic bone lesion confirmed by CT or MRI which can be followed
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Adequate organ function
Criterios de Exclusión
- Prior treatment with a selective estrogen receptor degrader (SERD), with the exception of fulvestrant, if fulvestrant treatment was terminated at least 28 days prior to randomization
- Treatment with any investigational therapy within 28 days prior to randomization
- Advanced, symptomatic, visceral spread that is at risk of life-threatening complications
- Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
- Active cardiac disease or history of cardiac dysfunction
- Pregnant or breastfeeding