A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer

Conditions

• Triple-negative Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody — DRUG
  Atezolizumab was administered as per schedule described in respective arm.
• Placebo — DRUG
  Placebo matched to atezolizumab was administered as per schedule described in respective arm.
• Nab-paclitaxel — DRUG
  Nab-paclitaxel was administered as per schedule described in the arms.
• Doxorubicin — DRUG
  Doxorubicin was administered as per schedule described in the arms.
• Cyclophosphamide — DRUG
  Cyclophosphamide was administered as per schedule described in the arms.
• Filgrastim — DRUG
  Filgrastim was administered according to local prescribing information as determined by the Investigator for 4 doses after completion of initial 12 weeks.
• Pegfilgrastim — DRUG
  Pegfilgrastim was administered according to local prescribing information as determined by the Investigator for 4 doses after completion of initial 12 weeks.

Study Details

This is a global Phase III, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (anti-programmed death-ligand 1 \[anti-PD-L1\] antibody) and nab-paclitaxel followed by doxorubicin and cyclophosphamide (nab-pac-AC), or placebo and nab-pac-AC in participants eligible for surgery with initial clinically assessed triple-negative breast cancer (TNBC).

Key Dates

Start date

Jul 24, 2017

Status verified

Oct 2023

Primary completion

Apr 3, 2020

Completion

Sep 28, 2022

Study Design

Enrollment

333 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Atezolizumab and Chemotherapy
  Participants received atezolizumab (840 milligrams \[mg\]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter \[mg/m\^2\]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m\^2) and cyclophosphamide (600 mg/m\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.
• Placebo Comparator: Placebo and Chemotherapy
  Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m\^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m\^2) and cyclophosphamide (600 mg/m\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will be unblinded post-surgery and will continue to be followed.

Primary Outcome Measure

Number of Participants With Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population [ Time Frame: After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020 ]

Locations (12)

Find similar trials in Palo Alto, CA

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