Atezolizumab for Metastatic Breast Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Metastatic Breast CancerAtezolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare two different treatments for people with late-stage breast cancer that is HER2-positive and PD-L1-positive. The first treatment is standard care, which consists of the drug trastuzumab emtansine plus atezolizumab. The second treatment is trastuzumab emtansine plus placebo. The trial will evaluate how well each treatment works and how safe each is.

Eligible Conditions
  • Metastatic Breast Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 14 Secondary · Reporting Duration: Baseline up to end of study (approximately 78 months)

Month 78
Central Nervous System (CNS) PFS as Determined by Investigator Assessment Using RECIST v1.1 in Participants with or Without Baseline CNS Metastases
Duration of Objective Response (DOR) as Determined by Investigator Assessment Using RECIST v1.1
PFS as Determined by a Blinded Independent Central Review Committee Using RECIST v1.1
PFS in Participants with Baseline Brain Metastases as Determined by Investigator Assessment Using RECIST v1.1
Percentage of Participants With Objective Response Rate (ORR) as Determined by Investigator's Assessment Using RECIST v1.1
Progression-Free Survival (PFS) as Determined by Investigator's Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)
Month 78
Percentage of Participants with Adverse Events (AEs) According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
Month 78
Trastuzumab
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Trastuzumab Emtansine
Month 78
Cmax of Atezolizumab
Percentage of Participants With ADAs to Atezolizumab
Month 3
Mean Absolute Scores in Function (Physical, Role) and Global Health Status (GHS)/Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30)
Mean Change-From-Baseline Scores in Function (Physical, Role) and GHS/QoL as Measured by the EORTC QLQ-C30
Percentage of Participants with Clinically Meaningful Deterioration in GHS/QoL Physical, and Role Function as Measured by the EORTC QLQ-C30
Month 78
OS in Participants with Baseline Brain Metastases
Overall Survival (OS)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Arm A: Trastuzumab Emtansine and Placebo
1 of 2
Arm B: Trastuzumab Emtansine and Atezolizumab
1 of 2

Active Control

Experimental Treatment

320 Total Participants · 2 Treatment Groups

Primary Treatment: Atezolizumab · Has Placebo Group · Phase 3

Arm B: Trastuzumab Emtansine and AtezolizumabExperimental Group · 2 Interventions: Atezolizumab, Trastuzumab Emtansine · Intervention Types: Drug, Drug
Arm A: Trastuzumab Emtansine and PlaceboActiveComparator Group · 2 Interventions: Trastuzumab Emtansine, Placebo · Intervention Types: Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
FDA approved
Trastuzumab emtansine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to end of study (approximately 78 months)

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,360 Previous Clinical Trials
1,093,371 Total Patients Enrolled
16 Trials studying Metastatic Breast Cancer
2,879 Patients Enrolled for Metastatic Breast Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,146 Previous Clinical Trials
901,425 Total Patients Enrolled
11 Trials studying Metastatic Breast Cancer
2,451 Patients Enrolled for Metastatic Breast Cancer

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
HER2+ and PD-L1+ LABC or MBC.
You have had no more than two prior lines of therapy in the metastatic setting.
If you are younger than 6 months, you must have a life expectancy of at least 6 months.