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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) | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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)

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Study of the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo in Patients With HER2-Positive and PD-L1-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab- (+/- Pertuzumab) and Taxane-Based Therapy (KATE3)

NCT04740918•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or MBC.Participants must have progressed either during or after prior trastuzumab- (+/- pertuzumab) and taxane-based therapy for LABC/MBC; or during (or within 6 months after completing) trastuzumab- (+/-pertuzumab) and taxane-based therapy in the neoadjuvant and/or adjuvant setting.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•HER2+ and PD-L1+ locally advanced (LABC) or metastatic breast cancer (MBC)
•Progression must have occurred during most recent treatment for LABC/MBC or during, or within 6 months after completing, neoadjuvant and/or adjuvant therapy
•Prior treatment with trastuzumab (+/- pertuzumab) and taxane in the neoadjuvant and/or adjuvant, locally advanced, or metastatic setting
•No more than two prior lines of therapy in the metastatic setting
•Measurable disease per RESIST version 1.1
•Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
•Life expectancy \>= 6 months
•Adequate hematologic and end-organ function
•For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs
•For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm

Exclusion Criteria

•Prior treatment with trastuzumab emtansine in metastatic setting
•History of exposure to cumulative doses of anthracyclines
•Symptomatic or actively progressing central nervous system (CNS) metastases; asymptomatic CNS lesions ≤ 2cm without clinical requirement for local intervention or asymptomatic patients with treated CNS lesions are eligible
•Current Grade \>= 3 peripheral neuropathy
•Cardiopulmonary dysfunction
•History of malignancy within 5 years prior to initiation of study treatment, with the exception of the cancer under investigation and malignancies with a negligible risk of metastasis or death
•History of leptomeningeal disease
•Active or history of autoimmune disease or immune deficiency
•Active hepatitis B, hepatitis C and/or tuberculosis
•Prior allogeneic stem cell or solid organ transplantation
+2 more criteria

Locations (51)

Emad Ibrahim, Md, Inc

Redlands, California, United States

Peter MacCallum Cancer Center

Melbourne, Victoria, Australia

Hospital Sao Rafael - HSR

Salvador, Estado de Bahia, Brazil

Hospital do Cancer de Pernambuco - HCP

Recife, Pernambuco, Brazil

Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

Ijuí, Rio Grande do Sul, Brazil

Hospital de Base de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Núcleo de Pesquisa São Camilo

São Paulo, São Paulo, Brazil

Royal Victoria Hospital

Barrie, Ontario, Canada

Centre Hospitalier de l?Université de Montréal (CHUM)

Montreal, Quebec, Canada

Peking University People's Hospital

Beijing, China

Key Dates

Start Date

June 7, 2021

Primary Completion Date

June 19, 2024

Completion Date

June 19, 2024

Last Updated

August 8, 2025

Enrollment

ACTUAL participants

Conditions

Metastatic Breast Cancer

Interventions

Trastuzumab Emtansine

DRUG

Atezolizumab

DRUG

Placebo

OTHER

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

NCT06625775

Solid Tumor, AdultMetastatic Breast Cancer+9 more

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RECRUITINGPHASE2

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

NCT06649331

Advanced Breast CancerMetastatic Breast Cancer+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

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