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Sponsor: Hoffmann-La Roche
Conditions: Metastatic Breast Cancer
Interventions: Trastuzumab Emtansine, Atezolizumab, Placebo
Countries: United States, Australia, Brazil, Canada, China, Colombia, Croatia, Finland
This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or MBC.Participants must have progressed either during or after prior trastuzumab- (+/- pertuzumab) and taxane-based therapy for LABC/MBC; or during (or within 6 months after completing) trastuzumab- (+/-pertuzumab) and taxane-based therapy in the neoadjuvant and/or adjuvant setting.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * HER2+ and PD-L1+ locally advanced (LABC) or metastatic breast cancer (MBC) * Progression must have occurred during most recent treatment for LABC/MBC or during, or within 6 months after completing, neoadjuvant and/or adjuvant therapy * Prior treatment with trastuzumab (+/- pertuzumab) and taxane in the neoadjuvant and/or adjuvant, locally advanced, or metastatic setting * No more than two prior lines of therapy in the metastatic setting * Measurable disease per RESIST version 1.1 * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Life expectancy \>= 6 months * Adequate hematologic and end-organ function * For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs * For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm Exclusion Criteria: * Prior treatment with trastuzumab emtansine in metastatic setting * History of exposure to cumulative doses of anthracyclines * Symptomatic or actively progressing central nervous system (CNS) metastases; asymptomatic CNS lesions ≤ 2cm without clinical requirement for local intervention or asymptomatic patients with treated CNS lesions are eligible * Current Grade \>= 3 peripheral neuropathy * Cardiopulmonary dysfunction * History of malignancy within 5 years prior to initiation of study treatment, with the exception of the cancer under investigation and malignancies with a negligible risk of metastasis or death * History of leptomeningeal disease * Active or history of autoimmune disease or immune deficiency * Active hepatitis B, hepatitis C and/or tuberculosis * Prior allogeneic stem cell or solid organ transplantation * Receipt of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, during treatment, or within 5 months following the last dose of study treatment * Pregnancy or lactation
- Redlands, California, United States
- Melbourne, Victoria, Australia
- Salvador, Estado de Bahia, Brazil
- Recife, Pernambuco, Brazil
- Ijuí, Rio Grande do Sul, Brazil
- São José do Rio Preto, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- Barrie, Ontario, Canada
- Montreal, Quebec, Canada
- Beijing, China
- Beijing, China
- Changchun, China
- Guangzhou, China
- Hangzhou, China
- Harbin, China
- Nanjing, China
- Tianjing, China
- Wuhan, China
- Zhengzhou, China
- Medellín, Colombia
- Montería, Colombia
- Zagreb, Croatia
- Zagreb, Croatia
- Helsinki, Finland
- Tampere, Finland
- Saint-Cloud, France
- Avellino, Campania, Italy
- Naples, Campania, Italy
- Bologna, Emilia-Romagna, Italy
- Oslo, Norway
- + 21 more on CT.gov