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

Activo, no reclutaFase 2ClinicalTrials.gov

ID: NCT04576455Tipo: INTERVENTIONALInicio: 27 de nov de 2020Fin estimado: 25 de ago de 2027

Oncología Endocrinología Obstetricia y Ginecología

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

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

Intervenciones

drug

Giredestrant

Giredestrant is taken orally once per day on Days 1-28 of each 28-day cycle.

drug

Fulvestrant or an Aromatase Inhibitor (Physician Choice)

Physician choice of endocrine monotherapy (fulvestrant or an aromatase inhibitor) is taken in accordance with the local prescribing information for the respective product.

drug

LHRH Agonist

Only premenopausal/perimenopausal participants and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.

Ubicaciones

Instituto Angel Roffo

Buenos Aires, Argentina

Fundación CENIT para la Investigación en Neurociencias

Buenos Aires, Argentina

Fundación Scherbovsky

Mendoza, Argentina

Hosp Provincial D. Centenarios

Rosario, Argentina

Organizacion Medica de Investigacion

San Nicolás, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

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