A Study of the Safety, Efficacy, and Pharmacokinetics of Tiragolumab in Combination With Atezolizumab and Chemotherapy in Participants With Triple-Negative Breast Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

83

Participants

Timeline

Start Date

September 28, 2020

Primary Completion Date

March 8, 2023

Study Completion Date

March 8, 2023

Conditions
Triple-Negative Breast Cancer
Interventions
DRUG

Tiragolumab

Tiragolumab 840 milligrams (mg) administered by intravenous (IV) infusion on Day 1 of every 28-day cycle.

DRUG

Atezolizumab

Atezolizumab 1680 mg administered by IV infusion on Day 1 of every 28-day cycle.

DRUG

Nab-paclitaxel

Nab-paclitaxel 100 milligrams per square meter (mg/m\^2) administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.

DRUG

Tiragolumab

Tiragolumab 420 mg administered by IV infusion Q2W.

DRUG

Atezolizumab

Atezolizumab 840 mg administered by IV infusion Q2W.

DRUG

Nab-paclitaxel

Nab-paclitaxel 125 mg/m\^2 administered by IV infusion QW.

DRUG

Carboplatin

Carboplatin (area under the concentration-time curve \[AUC\]: 5 milligrams per milliliter per minute \[mg/mL/min\]) administered by IV infusion Q3W.

DRUG

Doxorubicin

Doxorubicin 60 mg/m\^2 Q2W administered by IV infusion.

DRUG

Cyclophosphamide

Cyclophosphamide 600 mg/m\^2 Q2W administered by IV infusion.

DRUG

Granulocyte colony-stimulating factor (G-CSF)

G-CSF support for four doses.

DRUG

Granulocyte-macrophage colony-stimulating factor (GM-CSF)

GM-CSF support for four doses.

Trial Locations (24)

100

National Taiwan Uni Hospital; General Surgery, Taipei

404

China Medical University Hospital; Surgery, Taichung

4101

Mater Hospital; Cancer Services, South Brisbane

6149

Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit, Bull Creek

15213

Magee-Woman's Hospital, Pittsburgh

15706

Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia, Santiago de Compostela

28204

Levine Cancer Institute, Charlotte

37203

Tennessee Onc., PLLC - SCRI, Nashville

41009

Hospital Universitario Virgen Macarena; Servicio de Oncologia, Seville

45136

Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum, Essen

46010

Hospital Clínico Universitario de Valencia; Servicio de Oncología, Valencia

60637

Univ of Chicago, Chicago

69120

Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg, Heidelberg

111123

"SBIH Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM", Moskva

115478

Blokhin Cancer Research Center; Combined Treatment, Moskva

163045

Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk

35294-3300

University of Alabama at Birmingham, Birmingham

41253-190

Hospital Sao Rafael - HSR, Salvador

74605-070

Hospital Araujo Jorge; Departamento de Ginecologia E Mama, Goiânia

01308-050

Hospital Sírio-Libanês, São Paulo

01317-001

Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda, São Paulo

003-722

Severance Hospital, Yonsei University Health System, Seoul

03080

Seoul National University Hospital, Seoul

05505

Asan Medical Center, Seoul

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT04584112 - A Study of the Safety, Efficacy, and Pharmacokinetics of Tiragolumab in Combination With Atezolizumab and Chemotherapy in Participants With Triple-Negative Breast Cancer | Biotech Hunter | Biotech Hunter