What side effects are associated with this type of intervention?

Trastuzumab Emtansine (T-DM1) commonly causes side effects such as decreased neutrophil count, anemia, nausea, and interstitial lung disease. Atezolizumab, an immune checkpoint inhibitor, is associated with fatigue, decreased appetite, nausea, and immune-related adverse events like pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. Combining these treatments may heighten the risk of these side effects, necessitating close monitoring of patients.

What prior FDA approvals exist?

Trastuzumab Emtansine (T-DM1) is an FDA-approved antibody-drug conjugate for HER2-positive metastatic breast cancer, particularly for patients who have previously been treated with trastuzumab and a taxane. Atezolizumab, a PD-L1 inhibitor, has been approved for various cancers, including non-small cell lung cancer and urothelial carcinoma, but its combination with T-DM1 in breast cancer is still under investigation. Another similar treatment is Fam-trastuzumab deruxtecan (T-DXd), an ADC approved for HER2-positive breast cancer patients who have received prior anti-HER2 therapies.

What other types of research exist?

Promising alternatives include Trastuzumab Deruxtecan, which has shown significant efficacy in previously treated HER2-positive breast cancer, and the tucatinib-trastuzumab-capecitabine regimen, which has demonstrated effectiveness in treating leptomeningeal metastasis in HER2-positive breast cancer. Both options have shown potential in clinical trials and may be viable alternatives in 2024.

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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 from baseline until death or end of study (approximately 78 months)

Awards & highlights

Pivotal Trial

Summary

This trial tests a combination of two drugs versus one drug in patients with specific types of advanced or metastatic breast cancer who have not responded to previous treatments. The treatment works by directly killing cancer cells and enhancing the immune system's ability to fight cancer.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline until death or end of study (approximately 78 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline until death or end of study (approximately 78 months)

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Cmax of Atezolizumab

Trastuzumab

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)

+5 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

2016

Completed Phase 3

~5860

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer, such as antibody-drug conjugates (ADCs) and immune checkpoint inhibitors, work by targeting specific mechanisms in cancer cells. ADCs like Trastuzumab Emtansine bind to the HER2 receptor on cancer cells and deliver cytotoxic agents directly to these cells, reducing harm to normal cells. Immune checkpoint inhibitors like Atezolizumab target PD-L1, a protein that allows cancer cells to evade the immune system, thereby boosting the body's immune response against the cancer. These mechanisms are significant for breast cancer patients as they offer targeted, effective treatment options with potentially fewer side effects, improving overall treatment outcomes.

Human Epidermal Growth Factor Receptor 2-Targeting Approaches for Colorectal Cancer: Clinical Implications of Novel Treatments and Future Therapeutic Avenues.Metastatic breast cancer: Endocrine therapy landscape reshaped.Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer (EMILIA): a descriptive analysis of final overall survival results from a randomised, open-label, phase 3 trial.