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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04873362




Registration number
NCT04873362
Ethics application status
Date submitted
21/04/2021
Date registered
5/05/2021

Titles & IDs
Public title
A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy
Scientific title
A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy
Secondary ID [1] 0 0
2020-003681-40
Secondary ID [2] 0 0
WO42633
Universal Trial Number (UTN)
Trial acronym
Astefania
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

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

Active comparator: Arm A: Placebo + Trastuzumab Emtansine - Participants will receive an intravenous (IV) infusion of placebo prior to the IV infusion of trastuzumab emtansine on Day 1 of each 21-day cycle for a total of 14 cycles.

Experimental: Arm B: Atezolizumab + Trastuzumab Emtansine - Participants will receive an IV infusion of atezolizumab prior to the IV infusion of trastuzumab emtansine on Day 1 of each 21-day cycle for a total of 14 cycles.


Treatment: Drugs: Atezolizumab
Atezolizumab will be administered at a dose of 1200 mg every three weeks (Q3W) for 14 cycles.

Treatment: Drugs: Trastuzumab Emtansine
Trastuzumab emtansine will be administered at a dose of 3.6 mg/kg Q3W for 14 weeks.

Treatment: Drugs: Placebo
Placebo matched to atezolizumab will be administered at a dose of 1200 mg Q3W for 14 cycles.

Treatment: Drugs: Trastuzumab
Trastuzumab will be used to complete 14 cycles of study treatment if trastuzumab emtansine is discontinued for toxicity not considered to be related to the trastuzumab component of the drug.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Invasive Disease-free Survival (IDFS) in the Full Analysis Set (FAS)
Timepoint [1] 0 0
From baseline until the first occurrence of iDFS event or death, through primary analysis data cut off (approximately 7 years)
Secondary outcome [1] 0 0
IDFS Including Second Primary Non-breast Invasive Cancer
Timepoint [1] 0 0
From baseline until the first occurrence of iDFS event or death, through the end of study (approximately 10 years from last participant in [LPI])
Secondary outcome [2] 0 0
IDFS in the PD-L1-positive and the PD-L1-negative Population
Timepoint [2] 0 0
From baseline until the first occurrence of iDFS event or death, through the end of study (approximately 10 years from LPI)
Secondary outcome [3] 0 0
Disease-free Survival (DFS)
Timepoint [3] 0 0
From baseline until the first occurrence of DFS event or death, through the end of study (approximately 10 years from LPI)
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
From baseline to death from any cause through the end of study (approximately 10 years from LPI)
Secondary outcome [5] 0 0
Distant Recurrence-free Interval (DRFI)
Timepoint [5] 0 0
From baseline until distant disease recurrence, through the end of study (approximately 10 years from LPI)
Secondary outcome [6] 0 0
Number of Participants with Clinically Meaningful Deterioration in Global Health Status/Quality of Life (GHS/QoL) Physical, Role, and Cognitive Function
Timepoint [6] 0 0
From baseline until 2 years after study treatment completion/discontinuation visit (approximately 3 years)
Secondary outcome [7] 0 0
Mean Absolute Scores in GHS/QoL, Physical, Role, and Cognitive Function, as Assessed Using the EORTC QLQ-C30
Timepoint [7] 0 0
From baseline until 2 years after study treatment completion/discontinuation visit (approximately 3 years)
Secondary outcome [8] 0 0
Mean Change From Baseline Scores in GHS/QoL, Physical, Role, and Cognitive Function, as Assessed Using the EORTC QLQ-C30
Timepoint [8] 0 0
From baseline until 2 years after study treatment completion/discontinuation visit (approximately 3 years)
Secondary outcome [9] 0 0
Percentage of Participants with Adverse Events (AEs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
Timepoint [9] 0 0
From baseline up to 10 years
Secondary outcome [10] 0 0
Maximum Serum Concentrations (Cmax) for Atezolizumab
Timepoint [10] 0 0
Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, Day 1 of Cycles 2, 3 and 8 pre-infusion (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)
Secondary outcome [11] 0 0
Cmax for Trastuzumab Emtansine
Timepoint [11] 0 0
Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)
Secondary outcome [12] 0 0
Cmax for Total Trastuzumab
Timepoint [12] 0 0
Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)
Secondary outcome [13] 0 0
Cmax for DM1
Timepoint [13] 0 0
Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)
Secondary outcome [14] 0 0
Minimum Serum Concentrations (Cmin) for Atezolizumab
Timepoint [14] 0 0
Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, Day 1 of Cycles 2, 3 and 8 (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)
Secondary outcome [15] 0 0
Percentage of Participants with Anti-drug Antibodies (ADAs) to Atezolizumab
Timepoint [15] 0 0
Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, Day 1 of Cycles 2, 3 and 8 (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)
Secondary outcome [16] 0 0
Percentage of Participants with ADAs to Trastuzumab Emtansine
Timepoint [16] 0 0
Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)

Eligibility
Key inclusion criteria
* Histologically confirmed invasive breast carcinoma
* Centrally-confirmed human epidermal growth factor receptor 2 (HER2)-positive invasive breast cancer
* Centrally confirmed PD-L1 and hormone receptor status
* Clinical stage at disease presentation (prior to neoadjuvant therapy): cT4/anyN/M0, any cT/N2-3/M0, or cT1-3/N0-1/M0 (participants with cT1mi/T1a/T1b/N0 are not eligible)
* Completion of pre-operative systemic chemotherapy including at least 9 weeks of taxane and 9 weeks of trastuzumab (anthracycline and/or additional HER2-targeted agents are permitted)
* <=12 weeks between primary surgery and randomization
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
* Screening left ventricular ejection fraction (LVEF) >= 50% and no decrease in LVEF by >15% from the pre-chemotherapy LVEF. If no pre-chemotherapy LVEF, screening LVEF >= 55%
* Life expectancy >= 6 months
* Adequate hematologic and end organ function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Stage IV breast cancer
* An overall response of disease progression according to the investigator at the conclusion of preoperative systemic therapy
* Prior treatment with T-DM1, or atezolizumab, or other immune checkpoint inhibitors
* History of exposure to various cumulative doses of anthracyclines
* History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or ductal carcinoma in situ (DCIS)
* Current grade >=2 peripheral neuropathy
* History of idiopathic pulmonary fibrosis, organizing pneumonia, or pneumonitis
* History of or active autoimmune disease or immune deficiency
* Treatment with immunostimulatory or immunosuppressive agents
* Cardiopulmonary dysfunction
* Any known active liver disease

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/10/2034
Actual
Sample size
Target
1150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Macarthur Cancer Therapy Centre - Campbelltown
Recruitment hospital [2] 0 0
Kinghorn Cancer Centre; St Vincents Hospital - Darlinghurst
Recruitment hospital [3] 0 0
Royal North Shore Hospital; Department of Medical Oncology - St Leonards
Recruitment hospital [4] 0 0
Princess Alexandra Hospital; Cancer Trials Unit - Woolloongabba
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Centre; Medical Oncology - Melbourne
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment outside Australia
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United States of America
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Alabama
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California
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State/province [180] 0 0
Chia-Yi
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Taiwan
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Taichung
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Taiwan
State/province [182] 0 0
Tainan
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Taiwan
State/province [183] 0 0
Taipei 100
Country [184] 0 0
Taiwan
State/province [184] 0 0
Taipei
Country [185] 0 0
Thailand
State/province [185] 0 0
Bangkok
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Thailand
State/province [186] 0 0
Khon Kaen
Country [187] 0 0
Thailand
State/province [187] 0 0
Songkla
Country [188] 0 0
Turkey
State/province [188] 0 0
Adana
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Turkey
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Ankara
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Turkey
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Antalya
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Turkey
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Edirne
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Turkey
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Turkey
State/province [195] 0 0
Izmir
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Turkey
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Kadiköy
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Turkey
State/province [197] 0 0
Malatya
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Turkey
State/province [198] 0 0
Seyhan
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Turkey
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State/province [200] 0 0
Kampala
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Ukraine
State/province [201] 0 0
Katerynoslav Governorate
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Ukraine
State/province [202] 0 0
Kharkiv Governorate
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Ukraine
State/province [203] 0 0
Kholm Governorate
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Ukraine
State/province [204] 0 0
KIEV Governorate
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Ukraine
State/province [205] 0 0
Dnipropetrovsk
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Ukraine
State/province [206] 0 0
Kirovograd
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Ukraine
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Kyiv
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Belfast
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United Kingdom
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Blackpool
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United Kingdom
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Bradford
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United Kingdom
State/province [211] 0 0
Brighton
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United Kingdom
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Cambridge
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United Kingdom
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Cardiff
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Cheltenham
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Cornwall
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East Kilbride
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Inverness
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United Kingdom
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London
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United Kingdom
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Manchester
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Northwood
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Nottingham
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Preston
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Rhyl
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United Kingdom
State/province [224] 0 0
Somerset
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United Kingdom
State/province [225] 0 0
Surrey
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United Kingdom
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Walsall
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Hanoi
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Vietnam
State/province [228] 0 0
Ho Chi Minh City
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Vietnam
State/province [229] 0 0
Hochiminh city

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
Reference Study ID Number: WO42633 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. and Canada)
Fax 0 0
Email 0 0
[email protected]
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?
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).
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/NCT04873362