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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04740918




Registration number
NCT04740918
Ethics application status
Date submitted
3/02/2021
Date registered
5/02/2021

Titles & IDs
Public title
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)
Scientific 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)
Secondary ID [1] 0 0
2020-002818-41
Secondary ID [2] 0 0
MO42319
Universal Trial Number (UTN)
Trial acronym
KATE3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Trastuzumab Emtansine
Treatment: Drugs - Atezolizumab
Other interventions - Placebo

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.

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.


Treatment: Drugs: Trastuzumab Emtansine
Trastuzumab emtansine 3.6 mg/kg IV infusion

Treatment: Drugs: Atezolizumab
Atezolizumab 1200 mg IV infusion

Other interventions: Placebo
Placebo matched to atezolizumab
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) as Determined by Investigator's Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)
Timepoint [1] 0 0
Baseline until disease progression, death or end of study (approximately 78 months)
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
From baseline until death or end of study (approximately 78 months)
Secondary outcome [1] 0 0
Percentage of Participants With Objective Response Rate (ORR) as Determined by Investigator's Assessment Using RECIST v1.1
Timepoint [1] 0 0
Baseline until disease progression, death or end of study (approximately 78 months)
Secondary outcome [2] 0 0
Duration of Objective Response (DOR) as Determined by Investigator Assessment Using RECIST v1.1
Timepoint [2] 0 0
Baseline until disease progression, death or end of study (approximately 78 months)
Secondary outcome [3] 0 0
PFS as Determined by a Blinded Independent Central Review Committee Using RECIST v1.1
Timepoint [3] 0 0
Baseline until disease progression, death or end of study (approximately 78 months)
Secondary outcome [4] 0 0
PFS in Participants with Baseline Brain Metastases as Determined by Investigator Assessment Using RECIST v1.1
Timepoint [4] 0 0
Baseline until disease progression, death or end of study (approximately 78 months)
Secondary outcome [5] 0 0
OS in Participants with Baseline Brain Metastases
Timepoint [5] 0 0
From baseline until death or end of study (approximately 78 months)
Secondary outcome [6] 0 0
Central Nervous System (CNS) PFS as Determined by Investigator Assessment Using RECIST v1.1 in Participants with or Without Baseline CNS Metastases
Timepoint [6] 0 0
Baseline until disease progression, death or end of study (approximately 78 months)
Secondary outcome [7] 0 0
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)
Timepoint [7] 0 0
From Cycle 1 until 3 months after study completion
Secondary outcome [8] 0 0
Mean Change-From-Baseline Scores in Function (Physical, Role) and GHS/QoL as Measured by the EORTC QLQ-C30
Timepoint [8] 0 0
From Cycle 1 until 3 months after study completion
Secondary outcome [9] 0 0
Percentage of Participants with Clinically Meaningful Deterioration in GHS/QoL Physical, and Role Function as Measured by the EORTC QLQ-C30
Timepoint [9] 0 0
From Cycle 1 until 3 months after study completion
Secondary outcome [10] 0 0
Percentage of Participants with Adverse Events (AEs) According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
Timepoint [10] 0 0
Baseline up to end of study (approximately 78 months)
Secondary outcome [11] 0 0
Maximum Serum Concentration (Cmax) of Trastuzumab Emtansine
Timepoint [11] 0 0
Day 1 of Cycles 1, 2 and 4 (each cycle=21 days) and during study treatment completion/early discontinuation visit (approximately 78 months)
Secondary outcome [12] 0 0
Cmax of Atezolizumab
Timepoint [12] 0 0
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)
Secondary outcome [13] 0 0
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Trastuzumab Emtansine
Timepoint [13] 0 0
Day 1 of Cycles 1, 2 and 4 (each cycle=21 days) and during study treatment completion/early discontinuation visit (approximately 78 months)
Secondary outcome [14] 0 0
Percentage of Participants With ADAs to Atezolizumab
Timepoint [14] 0 0
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
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/06/2024
Sample size
Target
Accrual to date
Final
96
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Lake Macquarie Private Hospital - Gateshead
Recruitment hospital [2] 0 0
Royal North Shore Hospital; Oncology - St. Leonards
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Center - North Melbourne
Recruitment hospital [5] 0 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 0 0
2290 - Gateshead
Recruitment postcode(s) [2] 0 0
2065 - St. Leonards
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3051 - North Melbourne
Recruitment postcode(s) [5] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
Brazil
State/province [2] 0 0
BA
Country [3] 0 0
Brazil
State/province [3] 0 0
GO
Country [4] 0 0
Brazil
State/province [4] 0 0
RS
Country [5] 0 0
Brazil
State/province [5] 0 0
SP
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
China
State/province [8] 0 0
Beijing
Country [9] 0 0
China
State/province [9] 0 0
Changchun City
Country [10] 0 0
China
State/province [10] 0 0
Changsha City
Country [11] 0 0
China
State/province [11] 0 0
Guangzhou City
Country [12] 0 0
China
State/province [12] 0 0
Hangzhou
Country [13] 0 0
China
State/province [13] 0 0
Harbin
Country [14] 0 0
China
State/province [14] 0 0
Kunming City
Country [15] 0 0
China
State/province [15] 0 0
Nanjing City
Country [16] 0 0
China
State/province [16] 0 0
Shenzhen
Country [17] 0 0
China
State/province [17] 0 0
Tianjin
Country [18] 0 0
China
State/province [18] 0 0
Wuhan City
Country [19] 0 0
China
State/province [19] 0 0
Xian
Country [20] 0 0
China
State/province [20] 0 0
Zhejiang
Country [21] 0 0
China
State/province [21] 0 0
Zhengzhou
Country [22] 0 0
Colombia
State/province [22] 0 0
Medellin
Country [23] 0 0
Colombia
State/province [23] 0 0
Monteria
Country [24] 0 0
Colombia
State/province [24] 0 0
Pereira
Country [25] 0 0
Croatia
State/province [25] 0 0
Split
Country [26] 0 0
Croatia
State/province [26] 0 0
Zagreb
Country [27] 0 0
Finland
State/province [27] 0 0
Helsinki
Country [28] 0 0
Finland
State/province [28] 0 0
Oulu
Country [29] 0 0
Finland
State/province [29] 0 0
Tampere
Country [30] 0 0
France
State/province [30] 0 0
Amiens
Country [31] 0 0
France
State/province [31] 0 0
Bordeaux
Country [32] 0 0
France
State/province [32] 0 0
Grenoble
Country [33] 0 0
France
State/province [33] 0 0
Lille
Country [34] 0 0
France
State/province [34] 0 0
Nice
Country [35] 0 0
France
State/province [35] 0 0
Paris
Country [36] 0 0
France
State/province [36] 0 0
Poitiers
Country [37] 0 0
France
State/province [37] 0 0
Saint-Cloud
Country [38] 0 0
France
State/province [38] 0 0
Toulouse
Country [39] 0 0
Greece
State/province [39] 0 0
Athens
Country [40] 0 0
Greece
State/province [40] 0 0
Heraklion, Crete
Country [41] 0 0
Greece
State/province [41] 0 0
Thessaloniki
Country [42] 0 0
Italy
State/province [42] 0 0
Campania
Country [43] 0 0
Italy
State/province [43] 0 0
Emilia-Romagna
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Seoul
Country [45] 0 0
Norway
State/province [45] 0 0
Oslo
Country [46] 0 0
Philippines
State/province [46] 0 0
Cebu City
Country [47] 0 0
Philippines
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Quezon City
Country [48] 0 0
Philippines
State/province [48] 0 0
San Juan
Country [49] 0 0
Poland
State/province [49] 0 0
?ód?
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Poland
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Gdansk
Country [51] 0 0
Poland
State/province [51] 0 0
Konin
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Poland
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Kraków
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Poland
State/province [53] 0 0
Opole
Country [54] 0 0
Poland
State/province [54] 0 0
Poznan
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Poland
State/province [55] 0 0
Warszawa
Country [56] 0 0
Poland
State/province [56] 0 0
Wieliszew
Country [57] 0 0
Portugal
State/province [57] 0 0
Lisboa
Country [58] 0 0
Portugal
State/province [58] 0 0
Porto
Country [59] 0 0
Russian Federation
State/province [59] 0 0
Baskortostan
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Moskovskaja Oblast
Country [61] 0 0
Russian Federation
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Sankt Petersburg
Country [62] 0 0
Russian Federation
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Samara
Country [63] 0 0
Russian Federation
State/province [63] 0 0
Saratov
Country [64] 0 0
Slovenia
State/province [64] 0 0
Ljubljana
Country [65] 0 0
Spain
State/province [65] 0 0
Castellon
Country [66] 0 0
Spain
State/province [66] 0 0
Madrid
Country [67] 0 0
Spain
State/province [67] 0 0
Pontevedra
Country [68] 0 0
Spain
State/province [68] 0 0
Barcelona
Country [69] 0 0
Spain
State/province [69] 0 0
Malaga
Country [70] 0 0
Spain
State/province [70] 0 0
Sevilla
Country [71] 0 0
Turkey
State/province [71] 0 0
Adana
Country [72] 0 0
Turkey
State/province [72] 0 0
Adapazari/Sakarya
Country [73] 0 0
Turkey
State/province [73] 0 0
Ankara
Country [74] 0 0
Turkey
State/province [74] 0 0
Bakirkoy / Istanbul
Country [75] 0 0
Turkey
State/province [75] 0 0
Istanbul
Country [76] 0 0
Turkey
State/province [76] 0 0
Izmir
Country [77] 0 0
Turkey
State/province [77] 0 0
Kayseri
Country [78] 0 0
Turkey
State/province [78] 0 0
Sihhiye/Ankara
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Leicester
Country [80] 0 0
United Kingdom
State/province [80] 0 0
London
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Milton Keynes
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04740918