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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) (KATE3)

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ClinicalTrials.gov Identifier: NCT04740918
Recruitment Status : Active, not recruiting
First Posted : February 5, 2021
Last Update Posted : February 28, 2023
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Trastuzumab Emtansine Drug: Atezolizumab Other: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : June 7, 2021
Estimated Primary Completion Date : August 9, 2026
Estimated Study Completion Date : December 31, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm A: Trastuzumab Emtansine and Placebo
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.
 Drug: Trastuzumab Emtansine
Trastuzumab emtansine 3.6 mg/kg IV infusion
Other Name: Kadcyla, T-DM1, RO5304020

Other: Placebo
Placebo matched to atezolizumab
Experimental: Arm B: Trastuzumab Emtansine and Atezolizumab
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.
 Drug: Trastuzumab Emtansine
Trastuzumab emtansine 3.6 mg/kg IV infusion
Other Name: Kadcyla, T-DM1, RO5304020

Drug: Atezolizumab
Atezolizumab 1200 mg IV infusion
Other Name: Tecentriq, RO5541267, MPDL3280A


Outcome Measures
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Primary Outcome Measures :
  1. Progression-Free Survival (PFS) as Determined by Investigator's Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) [ Time Frame: Baseline until disease progression, death or end of study (approximately 78 months) ]
  2. Overall Survival (OS) [ Time Frame: From baseline until death or end of study (approximately 78 months) ]

Secondary Outcome Measures :
  1. Percentage of Participants With Objective Response Rate (ORR) as Determined by Investigator's Assessment Using RECIST v1.1 [ Time Frame: Baseline until disease progression, death or end of study (approximately 78 months) ]
  2. Duration of Objective Response (DOR) as Determined by Investigator Assessment Using RECIST v1.1 [ Time Frame: Baseline until disease progression, death or end of study (approximately 78 months) ]
  3. PFS as Determined by a Blinded Independent Central Review Committee Using RECIST v1.1 [ Time Frame: Baseline until disease progression, death or end of study (approximately 78 months) ]
  4. PFS in Participants with Baseline Brain Metastases as Determined by Investigator Assessment Using RECIST v1.1 [ Time Frame: Baseline until disease progression, death or end of study (approximately 78 months) ]
  5. OS in Participants with Baseline Brain Metastases [ Time Frame: From baseline until death or end of study (approximately 78 months) ]
  6. Central Nervous System (CNS) PFS as Determined by Investigator Assessment Using RECIST v1.1 in Participants with or Without Baseline CNS Metastases [ Time Frame: Baseline until disease progression, death or end of study (approximately 78 months) ]
  7. 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) [ Time Frame: From Cycle 1 until 3 months after study completion ]
  8. Mean Change-From-Baseline Scores in Function (Physical, Role) and GHS/QoL as Measured by the EORTC QLQ-C30 [ Time Frame: From Cycle 1 until 3 months after study completion ]
  9. Percentage of Participants with Clinically Meaningful Deterioration in GHS/QoL Physical, and Role Function as Measured by the EORTC QLQ-C30 [ Time Frame: From Cycle 1 until 3 months after study completion ]
  10. Percentage of Participants with Adverse Events (AEs) According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 [ Time Frame: Baseline up to end of study (approximately 78 months) ]
  11. Maximum Serum Concentration (Cmax) of Trastuzumab Emtansine [ Time Frame: Day 1 of Cycles 1, 2 and 4 (each cycle=21 days) and during study treatment completion/early discontinuation visit (approximately 78 months) ]
  12. Cmax of Atezolizumab [ Time Frame: Day 1 of Cycles 1, 2, 3, 4 and 8 and every 8 cycles thereafter (each cycle=21 days) and during study treatment completion/early discontinuation visit (approximately 78 months) ]
  13. Percentage of Participants With Anti-Drug Antibodies (ADAs) to Trastuzumab Emtansine [ Time Frame: Day 1 of Cycles 1, 2 and 4 (each cycle=21 days) and during study treatment completion/early discontinuation visit (approximately 78 months) ]
  14. Percentage of Participants With ADAs to Atezolizumab [ Time Frame: Day 1 of Cycles 1, 2, 3, 4 and 8 and every 8 cycles thereafter (each cycle=21 days) and during study treatment completion/early discontinuation visit (approximately 78 months) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Receipt of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, during treatment, or within 5 months following the last dose of study treatment
  • Pregnancy or lactation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04740918


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04740918    
Other Study ID Numbers: MO42319
2020-002818-41 ( EudraCT Number )
First Posted: February 5, 2021    Key Record Dates
Last Update Posted: February 28, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Ado-Trastuzumab Emtansine
Atezolizumab
 Maytansine
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action