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Monoclonal Antibodies

Trastuzumab Emtansine + Atezolizumab for Breast Cancer (KATE3 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 end of study (approximately 78 months)

Awards & highlights

KATE3 Trial 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.

Who is the study for?

This trial is for adults with HER2-positive and PD-L1-positive advanced or metastatic breast cancer who have had no more than two prior treatments in the metastatic setting. They must have seen their disease progress during or shortly after previous therapies, be relatively healthy otherwise, and not pregnant. Men and women must agree to use birth control.Check my eligibility

What is being tested?

The study tests if adding Atezolizumab to Trastuzumab Emtansine improves outcomes compared to using Trastuzumab Emtansine with a placebo. Participants are randomly assigned to one of these treatment groups and monitored for effectiveness and safety.See study design

What are the potential side effects?

Possible side effects include reactions at the infusion site, fatigue, liver issues, heart problems related to Trastuzumab Emtansine; immune-related effects like inflammation of organs due to Atezolizumab; plus general risks such as nausea and low blood cell counts.

KATE3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to end of study (approximately 78 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to end of study (approximately 78 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to end of study (approximately 78 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival (OS)

Progression-Free Survival (PFS) as Determined by Investigator's Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)

Secondary outcome measures

Central Nervous System (CNS) PFS as Determined by Investigator Assessment Using RECIST v1.1 in Participants with or Without Baseline CNS Metastases

Cmax of Atezolizumab

Duration of Objective Response (DOR) as Determined by Investigator Assessment Using RECIST v1.1

+11 more

KATE3 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm B: Trastuzumab Emtansine and AtezolizumabExperimental Treatment2 Interventions

Atezolizumab 1200 mg IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor.

Group II: Arm A: Trastuzumab Emtansine and PlaceboActive Control2 Interventions

Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trastuzumab Emtansine

2016

Completed Phase 3

~5630

Atezolizumab

2017

Completed Phase 3

~5860

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,428 Previous Clinical Trials

1,088,958 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

888,406 Total Patients Enrolled

138 Trials studying Breast Cancer

72,096 Patients Enrolled for Breast Cancer

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04740918 — Phase 3

Breast Cancer Research Study Groups: Arm A: Trastuzumab Emtansine and Placebo, Arm B: Trastuzumab Emtansine and Atezolizumab

Breast Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04740918 — Phase 3

Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04740918 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Atezolizumab a danger to people's health?

"Atezolizumab has received a score of 3 for safety. This is based off the fact that it is currently in Phase 3 trials, meaning that while there is data supporting efficacy, multiple rounds of testing have also supported its safety."

Answered by AI

What are Atezolizumab's most common indications?

"Atezolizumab is an immunotherapy treatment for small cell lung cancer (sclc), but it can also help patients with non-small cell lung carcinoma, malignant neoplasms, and postoperative conditions."

Answered by AI

Can you provide some context for Atezolizumab's clinical trial history?

"Atezolizumab was first trialled in 2008 at the Rocky Mountain Cancer Center. To date, there have been 18386 completed clinical trials worldwide. Of these, 390 are still active; a large portion of these ongoing studies taking place in Oshawa, Ontario."

Answered by AI

Have medical researchers conducted this kind of study before?

"Atezolizumab was first trialed in 2008 with subsequent clinical trials happening in the years since. In 2008, Hoffmann-La Roche sponsored the initial study which included 720 participants. After Phase 2 approval, there are now 390 live Atezolizumab trials taking place all over the world."

Answered by AI

What's the maximum capacity for this trial?

"320 individuals that meet the clinical study's eligibility requirements are required for the trial to commence. The sponsor, Hoffmann-La Roche, will be managing the research from different locations; these include Lakeridge Health Oshawa; Oncology in Oshawa, Ontario and Royal Victoria Hospital in Barrie, Texas."

Answered by AI

Can new subjects still participate in this research project?

"The trial, which began recruiting on 6/7/2021 according to clinicaltrials.gov, is still seeking participants."

Answered by AI

Is this research being conducted in several locations across North America?

"In total, this study is running at 11 different locations. These include Lakeridge Health Oshawa; Oncology in Oshawa, Ontario, Royal Victoria Hospital in Barrie, Texas, and The Ottawa Hospital Cancer Centre; Oncology in Ottawa, Pennsylvania among others."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC)

2021. "A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04740918.

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