A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer

Conditions

• Triple Negative Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab — DRUG
  Atezolizumab will be administered by IV, 840 mg every 2 weeks, for 10 doses. Atezolizumab maintenance will be administered by IV, 1200 mg every 3 weeks to complete 1 year
• Paclitaxel — DRUG
  Paclitaxel will be administered by IV, 80 mg/m\^2 every week for 12 weeks.
• Dose-dense Doxorubicin or dose-dense Epirubicin — DRUG
  Dose-dense doxorubicin will be administered by IV, 60 mg/m\^2 every 2 weeks for a total of 4 doses. Or Dose-dense epirubicin will be administered by IV, (90 mg/m\^2) every 2 weeks for a total of 4 doses
• Cyclophosphamide — DRUG
  Cyclophosphamide will be administered by IV, 600 mg/m\^2 every 2 weeks for 4 doses

Study Details

This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator's choice) and cyclophosphamide alone in patients with Stage II-III TNBC (Triple Negative Breast Cancer)

Key Dates

Start date

Aug 2, 2018

Status verified

Jul 2024

Primary completion

Aug 14, 2023

Completion

Aug 14, 2023

Study Design

Enrollment

2,199 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Atezolizumab + Chemotherapy
  Participants will receive atezolizumab (in combination with chemotherapy as described below) every 2 weeks for 10 doses, followed by atezolizumab maintenance therapy every 3 weeks to complete 1 year of treatment from the first dose Chemotherapy will consist of paclitaxel every week for 12 weeks, followed by dose-dense doxorubicin +cyclophosphamide or dose-dense epirubicin + cyclophosphamide every 2 weeks, for 4 doses supported with Granulocyte Colony-Stimulating Factor (G-CSF) or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)
• Active Comparator: Chemotherapy
  Chemotherapy will consist of paclitaxel every week for 12 weeks, followed by dose-dense doxorubicin +cyclophosphamide or dose-dense epirubicin + cyclophosphamide every 2 weeks, for 4 doses supported with Granulocyte Colony-Stimulating Factor (G-CSF) or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)

Primary Outcome Measure

Invasive Disease-Free Survival (iDFS) [ Time Frame: From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years) ]

Locations (17)

Find similar trials in Concord, CA

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