A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05382299Tipo: INTERVENTIONALInicio: 20 de jul de 2022Fin estimado: 1 de jul de 2028

Traducción no disponible, mostrando original

Resumen

The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) versus treatment of physician's choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (PD-L1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose tumors do express PD-L1.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Individuals, regardless of race and ethnic group, with previously untreated locally advanced, inoperable or metastatic triple-negative breast cancer (TNBC)
Individuals whose tumors are programmed cell death ligand 1 (PD-L1) negative at screening or individuals whose tumors are PD-L1 positive at screening if they have received an anti-PD-(L)1 inhibitor in the (neo) adjuvant setting or if they cannot be treated with a checkpoint inhibitor due to a comorbidity
Centrally confirmed TNBC and PD-L1 status on fresh or archival tissue
Individuals must have completed treatment for Stage I-III breast cancer, if indicated, and ≥ 6 months must have elapsed (with the exception of endocrine therapy) between completion of treatment with curative intent and first documented local or distant disease recurrence
Individuals presenting with de novo metastatic TNBC are eligible
Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) in accordance with per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. as evaluated locally
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Demonstrates adequate organ function
Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception
Individuals with human immunodeficiency virus (HIV) must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease

Criterios de exclusión

Positive serum pregnancy test or women who are lactating
Received systemic anticancer treatment within the previous 6 months or radiation therapy within 2 weeks prior to enrollment
Have not recovered from adverse events (AEs) due to a previously administered agent at the time study entry
May not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. Individuals participating in observational studies are eligible
Previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor
Active second malignancy
Active serious infection requiring antibiotics
Positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease
Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

Intervenciones

drug

Sacituzumab Govitecan-hziy

Administered intravenously

drug

Paclitaxel

Administered intravenously

drug

nab-Paclitaxel

Administered intravenously

drug

Gemcitabine

Administered intravenously

drug

Carboplatin

Administered intravenously

Ubicaciones

Hospital Británico de Buenos Aires

Buenos Aires, Argentina

Instituto de Oncologia Angel H.Roffo

CABA, Argentina

Fundacion CORI para la Investigacion y Prevencion del Cancer

Capital, Argentina

Instituto de Oncología de Rosario

Rosario, Argentina

Centro para la Atencion Integral del Paciente Oncologico Centro Médico C.A.I.P.O

San Miguel de Tucumán, Argentina

Clinica Viedma

Viedma, Argentina

Patrocinadores

PrincipalGilead Sciences

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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