NCT03197935|CompletedPhase 3ResultsFDA Drug

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

IMpassion031

A Phase III Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Neoadjuvant Anthracycline/Nab-Paclitaxel-Based Chemotherapy Compared With Placebo and Chemotherapy in Patients With Primary Invasive Triple-Negative Breast Cancer

Hoffmann-La Roche ClinicalTrials.gov

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2 other identifiers

WO393922016-004734-22

Study Type

interventional

Target

333

Locations

13 countries

Sites

Timeline

RegisteredJun 2017

StartedJul 2017

CompletionSep 2022

Brief Summary

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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

333

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Jul 2017

Longer than P75 for phase_3

Geographic Reach

13 countries

68 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.2 years study duration

First Submitted

Initial submission to the registry

June 21, 2017

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2017

Completed

1 month until next milestone

Study Start

First participant enrolled

July 24, 2017

Completed

2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2020

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

June 2, 2021

Completed

1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2022

Completed

Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

2.7 years

First QC Date

June 21, 2017

Results QC Date

March 29, 2021

Last Update Submit

October 23, 2023

Conditions

Triple-negative Breast Cancer

Outcome Measures

Primary Outcomes (2)

Number of Participants With Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population
Number of participants with Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population. pCR is defined as eradication of invasive tumor from both breast and lymph nodes (ypT0/is ypN0). pCR was evaluated for each participant after neoadjuvant study treatment and surgery. Participants whose pCR assessment was missing will be counted as not achieving a pCR.
After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020
Number of Participants With pCR in Subpopulation With PD-L1-Positive Tumor Status (Tumor-infiltrating Immune Cell [IC] 1/2/3) Using AJCC Staging System
Number of participants with Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in the subpopulation with programmed death-ligand1 (PD-L1)-positive tumor status(tumor-infiltrating immune cell \[IC\] IC1/2/3) . pCR is defined as eradication of invasive tumor from both breast and lymph nodes (ypT0/is ypN0). pCR was evaluated for each participant after neoadjuvant study treatment and surgery. Participants whose pCR assessment was missing will be counted as not achieving a pCR.
After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020

Secondary Outcomes (12)

Event-Free Survival (EFS) in All Participants
From randomization and up to study final analysis data cut off on 28 September 2022.
Event-Free Survival (EFS) in Subpopulation With PD-L1-Postive Tumor Status
From randomization and up to study final analysis data cut off on 28 September 2022.
Disease-Free Survival (DFS) in All Participants Who Undergo Surgery
From surgery and up to study final analysis data cut off on 28 September 2022.
Disease-Free Survival (DFS) in Subpopulation of Participants With PD-L1-Positive Tumor Status Who Undergo Surgery
From surgery and up to study final analysis data cut off on 28 September 2022.
Overall Survival (OS) in All Participants
From randomization and up to study final analysis data cut off on 28 September 2022.
+7 more secondary outcomes

Study Arms (2)

Atezolizumab and Chemotherapy

EXPERIMENTAL

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.

Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibodyDrug: Nab-paclitaxelDrug: DoxorubicinDrug: CyclophosphamideDrug: FilgrastimDrug: Pegfilgrastim

Placebo and Chemotherapy

PLACEBO COMPARATOR

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.

Drug: PlaceboDrug: Nab-paclitaxelDrug: DoxorubicinDrug: CyclophosphamideDrug: FilgrastimDrug: Pegfilgrastim

Interventions

Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibodyDRUG

Atezolizumab was administered as per schedule described in respective arm.

Atezolizumab and Chemotherapy

PlaceboDRUG

Placebo matched to atezolizumab was administered as per schedule described in respective arm.

Placebo and Chemotherapy

Nab-paclitaxelDRUG

Nab-paclitaxel was administered as per schedule described in the arms.