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

Phase 1

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cohort a: day 1 of cycles (cycle=28 days) 1, 2, 3, 4, 8, 12, and 16 and at td visit from start of treatment up to approximately 17 months; cohort b: day 1 of cycles (cycle=28 days) 1-5 and at td visit from start of treatment up to approximately 5 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination of two drugs and chemotherapy for patients with a hard-to-treat type of breast cancer. The goal is to boost the immune system's ability to fight the cancer while also killing the cancer cells directly.

Eligible Conditions

Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cohort a: day 1 of cycles (cycle=28 days) 1, 2, 3, 4, 8, 12, and 16 and at td visit from start of treatment up to approximately 17 months; cohort b: day 1 of cycles (cycle=28 days) 1-5 and at td visit from start of treatment up to approximately 5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cohort a: day 1 of cycles (cycle=28 days) 1, 2, 3, 4, 8, 12, and 16 and at td visit from start of treatment up to approximately 17 months; cohort b: day 1 of cycles (cycle=28 days) 1-5 and at td visit from start of treatment up to approximately 5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and cohort a: day 1 of cycles (cycle=28 days) 1, 2, 3, 4, 8, 12, and 16 and at td visit from start of treatment up to approximately 17 months; cohort b: day 1 of cycles (cycle=28 days) 1-5 and at td visit from start of treatment up to approximately 5 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Serum Concentrations of Tiragolumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort B: Tiragolumab and Atezolizumab + Nab-pac-carbo-ACExperimental Treatment8 Interventions

Participants with early TNBC in the neoadjuvant setting, who are eligible for surgery, will receive tiragolumab and atezolizumab every 2 weeks (Q2W) in combination with nab-paclitaxel weekly (QW) and carboplatin every 3 weeks (Q3W) for four cycles, followed by tiragolumab and atezolizumab in combination with doxorubicin and cyclophosphamide Q2W with granulocyte colony-stimulating factor (G-CSF; filgrastim or pegfilgrastim) or granulocyte-macrophage colony-stimulating factor (GM-CSF) support for four doses.

Group II: Cohort B: Tiragolumab and Atezolizumab + Nab-pac-ACExperimental Treatment7 Interventions

Participantswith early TNBC in the neoadjuvant setting, who are eligible for surgery, will receive tiragolumab and atezolizumab Q2W in combination with nab-paclitaxel QW for 12 weeks, followed by tiragolumab and atezolizumab in combination with doxorubicin and cyclophosphamide Q2W with G-CSF (filgrastim or pegfilgrastim) or GM-CSF support for four doses.

Group III: Cohort A: Tiragolumab and Atezolizumab + Nab-paclitaxelExperimental Treatment3 Interventions

Participants with first-line metastatic TNBC will receive tiragolumab and atezolizumab on Day 1 of every 28-day cycle plus nab-paclitaxel on Days 1, 8, and 15 of every 28-day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Doxorubicin

2012

Completed Phase 3

~8030

Cyclophosphamide

2010

Completed Phase 4

~2310