Your session is about to expire
← Back to Search
Monoclonal Antibodies
Nab-paclitaxel for Breast Cancer (IMpassion031 Trial)
Phase 3
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 baseline up to approximately 20 months
Awards & highlights
IMpassion031 Trial Summary
This trial is testing a new cancer treatment that could help people with triple-negative breast cancer.
Eligible Conditions
- Breast Cancer
IMpassion031 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to approximately 20 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to approximately 20 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population
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
Secondary outcome measures
Disease-Free Survival (DFS) in All Participants Who Undergo Surgery
Disease-Free Survival (DFS) in Subpopulation of Participants With PD-L1-Positive Tumor Status Who Undergo Surgery
Event-Free Survival (EFS) in All Participants
+9 moreIMpassion031 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Atezolizumab and ChemotherapyExperimental Treatment6 Interventions
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.
Group II: Placebo and ChemotherapyPlacebo Group6 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
2017
Completed Phase 3
~1890
Doxorubicin
2012
Completed Phase 3
~7940
Pegfilgrastim
2013
Completed Phase 3
~4410
Nab-paclitaxel
2014
Completed Phase 3
~2030
Cyclophosphamide
1995
Completed Phase 3
~3770
Filgrastim
2000
Completed Phase 3
~3670
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,721 Total Patients Enrolled
160 Trials studying Breast Cancer
91,467 Patients Enrolled for Breast Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,169 Total Patients Enrolled
138 Trials studying Breast Cancer
72,096 Patients Enrolled for Breast Cancer
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger