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

Conditions

• Triple-Negative Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tiragolumab — DRUG
  Tiragolumab 840 milligrams (mg) administered by intravenous (IV) infusion on Day 1 of every 28-day cycle.
• Atezolizumab — DRUG
  Atezolizumab 1680 mg administered by IV infusion on Day 1 of every 28-day cycle.
• Nab-paclitaxel — DRUG
  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.
• Tiragolumab — DRUG
  Tiragolumab 420 mg administered by IV infusion Q2W.
• Atezolizumab — DRUG
  Atezolizumab 840 mg administered by IV infusion Q2W.
• Nab-paclitaxel — DRUG
  Nab-paclitaxel 125 mg/m\^2 administered by IV infusion QW.
• Carboplatin — DRUG
  Carboplatin (area under the concentration-time curve \[AUC\]: 5 milligrams per milliliter per minute \[mg/mL/min\]) administered by IV infusion Q3W.
• Doxorubicin — DRUG
  Doxorubicin 60 mg/m\^2 Q2W administered by IV infusion.
• Cyclophosphamide — DRUG
  Cyclophosphamide 600 mg/m\^2 Q2W administered by IV infusion.
• Granulocyte colony-stimulating factor (G-CSF) — DRUG
  G-CSF support for four doses.
• Granulocyte-macrophage colony-stimulating factor (GM-CSF) — DRUG
  GM-CSF support for four doses.

Study Details

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 Dates

Start date

Sep 28, 2020

Status verified

Mar 2023

Primary completion

Mar 8, 2023

Completion

Mar 8, 2023

Study Design

Enrollment

83 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort A: Tiragolumab and Atezolizumab + Nab-paclitaxel
  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.
• Experimental: Cohort B: Tiragolumab and Atezolizumab + Nab-pac-carbo-AC
  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.
• Experimental: Cohort B: Tiragolumab and Atezolizumab + Nab-pac-AC
  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.

Primary Outcome Measure

Percentage of Participants With Adverse Events (Cohort B) [ Time Frame: Up to approximately 21 months ]

Locations (5)

Find similar trials in Birmingham, AL

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