A Study of the Safety, Efficacy, and Pharmacokinetics of Tiragolumab in Combination With Atezolizumab and Chemotherapy in Participants With Triple-Negative Breast Cancer
Completed · Phase 1
Conditions studied: Triple-Negative Breast Cancer
In brief
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of tiragolumab in combination with atezolizumab and chemotherapy in participants with metastatic and early triple-negative breast cancer (TNBC).
Key facts
- Study ID
- NCT04584112
- Run by
- Hoffmann-La Roche
- People needed
- 83
- Starts
- 2020-09-28
- Expected to finish
- 2023-03-08
- Last updated by the study team
- 2023-03-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Cohort A:
- Metastatic or locally advanced unresectable, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression
- Only patients with metastatic TNBC tumors that are centrally tested and found to be programmed death-ligand 1 (PD-L1) positive will be enrolled
- No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Measurable disease, as assessed by the investigator according to RECIST v1.1
- Adequate hematologic and end-organ function
- Cohort B:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically documented TNBC (negative HER2, ER, and PR status)
- Confirmed tumor PD-L1 evaluation as documented through central testing of a representative tumor tissue specimen
- Primary breast tumor size of greater than (>) 2 centimeters (cm) by at least one radiographic or clinical measurement
- Stage at presentation: cT2-cT4, cN0-cN3, cM0
- Baseline left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 53 percent (%) measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans
- Adequate hematologic and end-organ function
You may not qualify if…
- Cohort A:
- Formalin-fixed, paraffin-embedded (FFPE) tumor tissue that is PD-L1 negative, as determined on the SP142 PD-L1 immunohistochemistry assay, with positivity defined as immune cells greater than or equal to (>/=) 1%
- Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >2 weeks prior to initiation of study treatment
- Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases
- Leptomeningeal disease
- Cohort B:
- History of invasive breast cancer
- Stage IV (metastatic) breast cancer
- Prior systemic therapy for treatment and prevention of breast cancer
- Previous therapy with anthracyclines, platinum, or taxanes for any malignancy
- Synchronous, bilateral invasive breast cancer
- Cardiopulmonary dysfunction
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- Univ of Chicago — Chicago, Illinois, United States
- Levine Cancer Institute — Charlotte, North Carolina, United States
- Magee-Woman's Hospital — Pittsburgh, Pennsylvania, United States
- Tennessee Onc., PLLC - SCRI — Nashville, Tennessee, United States
- Mater Hospital; Cancer Services — South Brisbane, Queensland, Australia
- Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit — Bull Creek, Western Australia, Australia
- Hospital Sao Rafael - HSR — Salvador, Estado de Bahia, Brazil
- Hospital Araujo Jorge; Departamento de Ginecologia E Mama — Goiânia, Goiás, Brazil
- Hospital Sírio-Libanês — São Paulo, São Paulo, Brazil
- Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda — São Paulo, São Paulo, Brazil
- Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum — Essen, Germany
- Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg — Heidelberg, Germany
- Arkhangelsk Regional Clinical Oncology Dispensary — Arkhangelsk, Arhangelsk, Russia
- SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM" — Moskva, Moscow Oblast, Russia
- Blokhin Cancer Research Center; Combined Treatment — Moskva, Moscow Oblast, Russia
- Severance Hospital, Yonsei University Health System — Seoul, South Korea
- Seoul National University Hospital — Seoul, South Korea
- Asan Medical Center — Seoul, South Korea
- Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia — Santiago de Compostela, LA Coruña, Spain
- Hospital Universitario Virgen Macarena; Servicio de Oncologia — Seville, Spain
- Hospital Clínico Universitario de Valencia; Servicio de Oncología — Valencia, Spain
- China Medical University Hospital; Surgery — Taichung, Taiwan
- National Taiwan Uni Hospital; General Surgery — Taipei, Taiwan
Full record on ClinicalTrials.gov
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