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

NCT04584112 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2023-03-15

No results posted yet for this study

Summary

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).

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-28
Primary Completion
2023-03-08
Completion
2023-03-08
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Germany
  • Russia
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04584112 on ClinicalTrials.gov