A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer

CompletadoFase 3ClinicalTrials.gov

ID: NCT02425891Tipo: INTERVENTIONALInicio: 23 de jun de 2015Fin estimado: 31 de ago de 2021

Traducción no disponible, mostrando original

Resumen

This multicenter, randomized, double-blind study evaluated the efficacy, safety, and pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been determined in previous studies of participants with mBC and the safety data to date suggest that atezolizumab can be safely combined with standard chemotherapy agents.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Metastatic or locally advanced, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression
No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC
Eligible for taxane monotherapy (i.e., absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control)
A representative formalin-fixed, paraffin-embedded tumor specimen in paraffin blocks, or at least 20 unstained slides with an associated pathology report documenting ER, PR, and HER2 negativity. Participants with fewer than 20 unstained slides available at baseline, and not fewer than 12 unstained slides will be eligible upon discussion with Medical Monitor
Eastern Cooperative Oncology Group performance status of 0 or 1
Measurable disease as defined by RECIST v1.1
Adequate hematologic and end-organ function

Criterios de exclusión

Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases
Leptomeningeal disease
Pregnancy or lactation
History of autoimmune disease
Prior allogeneic stem cell or solid organ transplantation
Positive test for human immunodeficiency virus
Active hepatitis B or hepatitis C
Receipt of a live, attenuated vaccine within 4 weeks prior to randomization, during treatment, or within 5 months following the last dose of atezolizumab/placebo

Intervenciones

drug

Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody

Atezolizumab at a fixed dose of 840 milligrams via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle until disease progression or unacceptable toxicity.

drug

Nab-Paclitaxel

Nab-Paclitaxel at a starting dose of 100 milligrams per square meter via IV infusion on Days 1, 8, and 15 of each 28-day cycle. Nab-Paclitaxel was administered for a target of at least 6 cycles, with no maximum in the absence of disease progression or unacceptable toxicity.

drug

Placebo

Placebo administered via IV infusion on Days 1 and 15 of each 28-day cycle until disease progression or unacceptable toxicity.

Ubicaciones

Centro de Oncologia e Investigacion Buenos Aires (COIBA)

Buenos Aires, Argentina

Fundación CENIT para la Investigación en Neurociencias

Buenos Aires, Argentina

Centro Oncologico Riojano Integral (CORI)

La Rioja, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

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