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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03498716




Registration number
NCT03498716
Ethics application status
Date submitted
28/02/2018
Date registered
17/04/2018
Date last updated
15/09/2023

Titles & IDs
Public title
A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer
Scientific title
A Phase III, Multicenter, Randomized, Open-Label Study Comparing Atezolizumab (Anti PD-L1 Antibody) in Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone in Patients With Operable Triple Negative Breast Cancer
Secondary ID [1] 0 0
2016-003695-47
Secondary ID [2] 0 0
WO39391
Universal Trial Number (UTN)
Trial acronym
IMpassion030
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Triple Negative 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 - Atezolizumab
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Dose-dense Doxorubicin or dose-dense Epirubicin
Treatment: Drugs - Cyclophosphamide

Experimental: Atezolizumab + Chemotherapy - Participants will receive atezolizumab (in combination with chemotherapy as described below) every 2 weeks for 10 doses, followed by atezolizumab maintenance therapy every 3 weeks to complete 1 year of treatment from the first dose
Chemotherapy will consist of paclitaxel every week for 12 weeks, followed by dose-dense doxorubicin +cyclophosphamide or dose-dense epirubicin + cyclophosphamide every 2 weeks, for 4 doses supported with Granulocyte Colony-Stimulating Factor (G-CSF) or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)

Active Comparator: Chemotherapy - Chemotherapy will consist of paclitaxel every week for 12 weeks, followed by dose-dense doxorubicin +cyclophosphamide or dose-dense epirubicin + cyclophosphamide every 2 weeks, for 4 doses supported with Granulocyte Colony-Stimulating Factor (G-CSF) or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)


Treatment: Drugs: Atezolizumab
Atezolizumab will be administered by IV, 840 mg every 2 weeks, for 10 doses.
Atezolizumab maintenance will be administered by IV, 1200 mg every 3 weeks to complete 1 year

Treatment: Drugs: Paclitaxel
Paclitaxel will be administered by IV, 80 mg/m^2 every week for 12 weeks.

Treatment: Drugs: Dose-dense Doxorubicin or dose-dense Epirubicin
Dose-dense doxorubicin will be administered by IV, 60 mg/m^2 every 2 weeks for a total of 4 doses.
Or
Dose-dense epirubicin will be administered by IV, (90 mg/m^2) every 2 weeks for a total of 4 doses

Treatment: Drugs: Cyclophosphamide
Cyclophosphamide will be administered by IV, 600 mg/m^2 every 2 weeks for 4 doses
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Invasive Disease-Free Survival (iDFS)
Timepoint [1] 0 0
Randomization until the first occurrence of iDFS event or death, through the end of study (approximately 7 years).
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Randomization to death from any cause through the end of study (approximately 7 years)
Secondary outcome [2] 0 0
Disease-Free Survival (DFS)
Timepoint [2] 0 0
Randomization until the first occurrence of an DFS event, through the end of study (approximately 7 years)
Secondary outcome [3] 0 0
Recurrence-Free Interval (RFI)
Timepoint [3] 0 0
Randomization until local, regional, or distant disease recurrence of breast cancer, through the end of study (approximately 7 years)
Secondary outcome [4] 0 0
Distant RFI
Timepoint [4] 0 0
Randomization until distant disease recurrence, through the end of study (approximately 7 years)
Secondary outcome [5] 0 0
Percentage of participants with adverse events
Timepoint [5] 0 0
Baseline to end of study (approximately 7 years)
Secondary outcome [6] 0 0
Serum concentration of Atezolizumab
Timepoint [6] 0 0
Pre-infusion (0 hour), 30 minutes post-infusion on Week 1 Day 1 (infusion length = 60 minutes); pre-infusion on Day 1 of Weeks 5, 9, 13, 21, 33 and 45; at treatment discontinuation (up to approximately 1 year), 120 days after last dose
Secondary outcome [7] 0 0
Invasive Disease-Free Survival (iDFS) in PDL1- Selected Patients
Timepoint [7] 0 0
Randomization until the first occurrence of iDFS event or death, through the end of study (approximately 7 years)
Secondary outcome [8] 0 0
Invasive Disease-Free Survival (iDFS) in Node- Positive Disease
Timepoint [8] 0 0
Randomization until the first occurrence of iDFS event or death, through the end of study (approximately 7 years)
Secondary outcome [9] 0 0
Invasive Disease Free Survival (iDFS) including second primary non-breast invasive cancer
Timepoint [9] 0 0
Randomization until the first occurrence of iDFS event or death, through the end of study (approximately 7 years)
Secondary outcome [10] 0 0
Percentage of Participants with Anti-Drug Antibodies (ADAs) to Atezolizumab
Timepoint [10] 0 0
Updated: Pre-infusion (0 hour) on Day 1 of Weeks 1, 5, 9, 13, 21, 33 and 45; at treatment discontinuation (up to Week 51), 120 days after last dose
Secondary outcome [11] 0 0
Mean changes from baseline in patient-reported function (role, physical)
Timepoint [11] 0 0
Baseline, Cycle 4 Day 1, Day 1 of every other cycle until Cycle 16 (cycle = 21 days), at the end of treatment/discontinuation visit ((up to approximately 1 year), and during Study Follow-up (up to approximately 7 years).
Secondary outcome [12] 0 0
Mean changes from baseline in patient-reported health-related quality of life (HRQoL)
Timepoint [12] 0 0
Time Frame: Baseline, Cycle 4 Day 1, Day 1 of every other cycle until Cycle 16 (cycle = 21 days), at the end of treatment/discontinuation visit (up to approximately 1 year), and during Study Follow-up (up to approximately 7 years).

Eligibility
Key inclusion criteria
- Non-metastatic operable Stage II-III breast cancer

- Histologically documented TNBC (Triple Negative Breast Cancer)

- Confirmed tumor PD-L1 evaluation as documented through central testing of a
representative tumor tissue specimen

- Adequately excised: Patients must have undergone either breast-conserving surgery or
mastectomy/nipple- or skin-sparing mastectomy

- Adequate hematologic and end-organ function

- For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraceptive measures

- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use
contraceptive measures and agreement to refrain from donating sperm.

- No more than 8 weeks (56 days) may elapse between definitive breast surgery and
randomization.

- Representative formalin-fixed, paraffin embedded (FFPE) tumor specimen from surgical
resection in paraffin blocks (preferred) or at least 25 unstained slides.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

- Prior history of invasive breast cancer

- For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment
(e.g., neoadjuvant or adjuvant), including, but not limited to, chemotherapy,
anti-HER2 therapy.

- Previous therapy with anthracyclines or taxanes for any malignancy

- Cardiopulmonary dysfunction

- Prior malignancies within 5 years prior to randomization, with the exception of those
with a negligible risk of metastasis or death and treated with expected curative
outcome

- Active or history of autoimmune disease or immune deficiency

- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening
chest computed tomography (CT) scan

- Urinary outflow obstruction

- Active tuberculosis

- Major surgical procedure other than for diagnosis within 4 weeks prior to initiation
of study treatment or anticipation of need for a major surgical procedure during study
treatment or within 5 months following the last dose of Atezolizumab (for patients
randomized to Atezolizumab)

- Prior allogeneic stem cell or solid organ transplant

- Treatment with systemic immunosuppressive medications within 2 weeks prior to
initiation of study treatment or anticipation of need for systemic immunosuppressive
medication during the study

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/08/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/08/2023
Sample size
Target
Accrual to date
Final
2203
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Lismore Base Hospital - Lismore
Recruitment hospital [3] 0 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [4] 0 0
Tweed Hospital - Tweed Heads
Recruitment hospital [5] 0 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [6] 0 0
Icon Cancer Care Wesley - Auchenflower
Recruitment hospital [7] 0 0
Icon Cancer Foundation; Icon Cancer Care Chermside - Chermside
Recruitment hospital [8] 0 0
Icon Cancer Care South Brisbane - South Brisbane
Recruitment hospital [9] 0 0
Mater Hospital; Cancer Services - South Brisbane
Recruitment hospital [10] 0 0
Icon Cancer Foundation; Icon Cancer Care Southport - Southport
Recruitment hospital [11] 0 0
Princess Alexandra Hospital; Cancer Trials Unit - Woolloongabba
Recruitment hospital [12] 0 0
Royal Adelaide Hospital; Cancer Centre - Adelaide
Recruitment hospital [13] 0 0
Ashford Cancer Center Research - Kurralta Park
Recruitment hospital [14] 0 0
Box Hill Hospital; Eastern Clinical Research Unit - Box Hill
Recruitment hospital [15] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [16] 0 0
Austin Hospital Olivia Newton John Cancer Centre - Heidelberg
Recruitment hospital [17] 0 0
Maroondah Hospital; Breast Clinic - Ringwood East
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2480 - Lismore
Recruitment postcode(s) [3] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [4] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [5] 0 0
2076 - Wahroonga
Recruitment postcode(s) [6] 0 0
4066 - Auchenflower
Recruitment postcode(s) [7] 0 0
4032 - Chermside
Recruitment postcode(s) [8] 0 0
4101 - South Brisbane
Recruitment postcode(s) [9] 0 0
4215 - Southport
Recruitment postcode(s) [10] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [11] 0 0
5000 - Adelaide
Recruitment postcode(s) [12] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [13] 0 0
3128 - Box Hill
Recruitment postcode(s) [14] 0 0
3168 - Clayton
Recruitment postcode(s) [15] 0 0
3084 - Heidelberg
Recruitment postcode(s) [16] 0 0
3135 - Ringwood East
Recruitment outside Australia
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State/province [172] 0 0
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Stoke-On-Trent

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Breast International Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Alliance Foundation Trials (AFT)
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Institut Jules Bordet/Clinical Trials Support Unit (IJB/CTSU)
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Commercial sector/Industry
Name [4] 0 0
Frontier Science & Technology Research Foundation, Inc.
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab
in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or
epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed
by dose-dense doxorubicin or epirubicin (investigator's choice) and cyclophosphamide alone in
patients with Stage II-III TNBC (Triple Negative Breast Cancer)
Trial website
https://clinicaltrials.gov/ct2/show/NCT03498716
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