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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
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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
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Secondary ID [1]
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2016-003695-47
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Secondary ID [2]
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WO39391
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Universal Trial Number (UTN)
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Trial acronym
IMpassion030
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Triple Negative Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Invasive Disease-Free Survival (iDFS)
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Assessment method [1]
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iDFS events are defined as follows:
Ipsilateral invasive breast tumor recurrence
Ipsilateral local-regional invasive breast cancer recurrence
Ipsilateral second primary invasive breast cancer
Contralateral invasive breast cancer
Distant recurrence
Death attributable to any cause
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Timepoint [1]
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Randomization until the first occurrence of iDFS event or death, through the end of study (approximately 7 years).
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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Timepoint [1]
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Randomization to death from any cause through the end of study (approximately 7 years)
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Secondary outcome [2]
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Disease-Free Survival (DFS)
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Assessment method [2]
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DFS is defined as any event of the primary endpoint and new diagnosis of an ipsilateral or contralateral non-invasive breast cancer.
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Timepoint [2]
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Randomization until the first occurrence of an DFS event, through the end of study (approximately 7 years)
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Secondary outcome [3]
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Recurrence-Free Interval (RFI)
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Assessment method [3]
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Timepoint [3]
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Randomization until local, regional, or distant disease recurrence of breast cancer, through the end of study (approximately 7 years)
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Secondary outcome [4]
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Distant RFI
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Assessment method [4]
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Timepoint [4]
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Randomization until distant disease recurrence, through the end of study (approximately 7 years)
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Secondary outcome [5]
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Percentage of participants with adverse events
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Assessment method [5]
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Safety Objective
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Timepoint [5]
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Baseline to end of study (approximately 7 years)
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Secondary outcome [6]
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Serum concentration of Atezolizumab
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Assessment method [6]
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Timepoint [6]
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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
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Secondary outcome [7]
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Invasive Disease-Free Survival (iDFS) in PDL1- Selected Patients
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Assessment method [7]
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Timepoint [7]
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Randomization until the first occurrence of iDFS event or death, through the end of study (approximately 7 years)
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Secondary outcome [8]
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Invasive Disease-Free Survival (iDFS) in Node- Positive Disease
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Assessment method [8]
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Timepoint [8]
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Randomization until the first occurrence of iDFS event or death, through the end of study (approximately 7 years)
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Secondary outcome [9]
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Invasive Disease Free Survival (iDFS) including second primary non-breast invasive cancer
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Assessment method [9]
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Timepoint [9]
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Randomization until the first occurrence of iDFS event or death, through the end of study (approximately 7 years)
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Secondary outcome [10]
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Percentage of Participants with Anti-Drug Antibodies (ADAs) to Atezolizumab
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Assessment method [10]
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Timepoint [10]
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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
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Secondary outcome [11]
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Mean changes from baseline in patient-reported function (role, physical)
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Assessment method [11]
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Mean changes from baseline score in role, physical function will be assessed using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire - Core 30 (EORTC QLQ-C30)
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Timepoint [11]
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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).
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Secondary outcome [12]
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Mean changes from baseline in patient-reported health-related quality of life (HRQoL)
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Assessment method [12]
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Mean changes from baseline score in HRQoL will be assessed using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire - Core 30 (EORTC QLQ-C30).
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Timepoint [12]
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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).
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/08/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
14/08/2023
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Sample size
Target
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Accrual to date
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Final
2203
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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St Vincent's Hospital Sydney - Darlinghurst
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Lismore Base Hospital - Lismore
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Macquarie University Hospital - Macquarie Park
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Tweed Hospital - Tweed Heads
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Sydney Adventist Hospital - Wahroonga
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Icon Cancer Care Wesley - Auchenflower
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Recruitment hospital [7]
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Icon Cancer Foundation; Icon Cancer Care Chermside - Chermside
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Icon Cancer Care South Brisbane - South Brisbane
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Mater Hospital; Cancer Services - South Brisbane
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Icon Cancer Foundation; Icon Cancer Care Southport - Southport
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Princess Alexandra Hospital; Cancer Trials Unit - Woolloongabba
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Royal Adelaide Hospital; Cancer Centre - Adelaide
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Ashford Cancer Center Research - Kurralta Park
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Box Hill Hospital; Eastern Clinical Research Unit - Box Hill
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Monash Medical Centre - Clayton
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Austin Hospital Olivia Newton John Cancer Centre - Heidelberg
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Recruitment hospital [17]
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Maroondah Hospital; Breast Clinic - Ringwood East
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2480 - Lismore
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Recruitment postcode(s) [3]
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2109 - Macquarie Park
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2485 - Tweed Heads
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Recruitment postcode(s) [5]
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2076 - Wahroonga
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Recruitment postcode(s) [6]
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4066 - Auchenflower
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Recruitment postcode(s) [7]
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4032 - Chermside
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4101 - South Brisbane
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Recruitment postcode(s) [9]
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4215 - Southport
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4102 - Woolloongabba
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Recruitment postcode(s) [11]
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5000 - Adelaide
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Recruitment postcode(s) [12]
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5037 - Kurralta Park
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Recruitment postcode(s) [13]
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3128 - Box Hill
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Recruitment postcode(s) [14]
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3168 - Clayton
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Recruitment postcode(s) [15]
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3084 - Heidelberg
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Recruitment postcode(s) [16]
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3135 - Ringwood East
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Recruitment outside Australia
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France
Query!
State/province [83]
0
0
Contamine Sur Arve
Query!
Country [84]
0
0
France
Query!
State/province [84]
0
0
Dijon
Query!
Country [85]
0
0
France
Query!
State/province [85]
0
0
La Roche Sur Yon
Query!
Country [86]
0
0
France
Query!
State/province [86]
0
0
Limoges
Query!
Country [87]
0
0
France
Query!
State/province [87]
0
0
Lorient
Query!
Country [88]
0
0
France
Query!
State/province [88]
0
0
Lyon
Query!
Country [89]
0
0
France
Query!
State/province [89]
0
0
Marseille
Query!
Country [90]
0
0
France
Query!
State/province [90]
0
0
Montpellier
Query!
Country [91]
0
0
France
Query!
State/province [91]
0
0
Nantes
Query!
Country [92]
0
0
France
Query!
State/province [92]
0
0
Nice
Query!
Country [93]
0
0
France
Query!
State/province [93]
0
0
Pringy
Query!
Country [94]
0
0
France
Query!
State/province [94]
0
0
Quimper
Query!
Country [95]
0
0
France
Query!
State/province [95]
0
0
Reims
Query!
Country [96]
0
0
France
Query!
State/province [96]
0
0
Rouen
Query!
Country [97]
0
0
France
Query!
State/province [97]
0
0
St Priest en Jarez CEDEX
Query!
Country [98]
0
0
France
Query!
State/province [98]
0
0
Strasbourg
Query!
Country [99]
0
0
France
Query!
State/province [99]
0
0
Thonon Les Bains
Query!
Country [100]
0
0
France
Query!
State/province [100]
0
0
Toulouse
Query!
Country [101]
0
0
France
Query!
State/province [101]
0
0
Tours
Query!
Country [102]
0
0
France
Query!
State/province [102]
0
0
Valence
Query!
Country [103]
0
0
France
Query!
State/province [103]
0
0
Vandoeuvre-Les-Nancy
Query!
Country [104]
0
0
France
Query!
State/province [104]
0
0
Villejuif
Query!
Country [105]
0
0
Germany
Query!
State/province [105]
0
0
Berlin
Query!
Country [106]
0
0
Germany
Query!
State/province [106]
0
0
Dortmund
Query!
Country [107]
0
0
Germany
Query!
State/province [107]
0
0
Dresden
Query!
Country [108]
0
0
Germany
Query!
State/province [108]
0
0
Erfurt
Query!
Country [109]
0
0
Germany
Query!
State/province [109]
0
0
Gütersloh
Query!
Country [110]
0
0
Germany
Query!
State/province [110]
0
0
Hamburg
Query!
Country [111]
0
0
Germany
Query!
State/province [111]
0
0
Hildesheim
Query!
Country [112]
0
0
Germany
Query!
State/province [112]
0
0
Karlsruhe
Query!
Country [113]
0
0
Germany
Query!
State/province [113]
0
0
Köln
Query!
Country [114]
0
0
Germany
Query!
State/province [114]
0
0
Ludwigsburg
Query!
Country [115]
0
0
Germany
Query!
State/province [115]
0
0
Mainz
Query!
Country [116]
0
0
Germany
Query!
State/province [116]
0
0
Mayen
Query!
Country [117]
0
0
Germany
Query!
State/province [117]
0
0
Memmingen
Query!
Country [118]
0
0
Germany
Query!
State/province [118]
0
0
Minden
Query!
Country [119]
0
0
Germany
Query!
State/province [119]
0
0
Mönchengladbach
Query!
Country [120]
0
0
Germany
Query!
State/province [120]
0
0
München
Query!
Country [121]
0
0
Germany
Query!
State/province [121]
0
0
Neumarkt i.d.OPf.
Query!
Country [122]
0
0
Germany
Query!
State/province [122]
0
0
Offenbach
Query!
Country [123]
0
0
Germany
Query!
State/province [123]
0
0
Stendal
Query!
Country [124]
0
0
Germany
Query!
State/province [124]
0
0
Stralsund
Query!
Country [125]
0
0
Germany
Query!
State/province [125]
0
0
Tübingen
Query!
Country [126]
0
0
Germany
Query!
State/province [126]
0
0
Weinheim
Query!
Country [127]
0
0
Germany
Query!
State/province [127]
0
0
Witten
Query!
Country [128]
0
0
Germany
Query!
State/province [128]
0
0
Worms
Query!
Country [129]
0
0
Hong Kong
Query!
State/province [129]
0
0
Hong Kong
Query!
Country [130]
0
0
Hong Kong
Query!
State/province [130]
0
0
Kowloon
Query!
Country [131]
0
0
Hungary
Query!
State/province [131]
0
0
Budapest
Query!
Country [132]
0
0
Hungary
Query!
State/province [132]
0
0
Miskolc
Query!
Country [133]
0
0
Hungary
Query!
State/province [133]
0
0
Pécs
Query!
Country [134]
0
0
Ireland
Query!
State/province [134]
0
0
Dublin
Query!
Country [135]
0
0
Israel
Query!
State/province [135]
0
0
Jerusalem
Query!
Country [136]
0
0
Israel
Query!
State/province [136]
0
0
Kfar Sava
Query!
Country [137]
0
0
Israel
Query!
State/province [137]
0
0
Petach Tikva
Query!
Country [138]
0
0
Israel
Query!
State/province [138]
0
0
Ramat Gan
Query!
Country [139]
0
0
Italy
Query!
State/province [139]
0
0
Abruzzo
Query!
Country [140]
0
0
Italy
Query!
State/province [140]
0
0
Emilia-Romagna
Query!
Country [141]
0
0
Italy
Query!
State/province [141]
0
0
Friuli-Venezia Giulia
Query!
Country [142]
0
0
Italy
Query!
State/province [142]
0
0
Lazio
Query!
Country [143]
0
0
Italy
Query!
State/province [143]
0
0
Liguria
Query!
Country [144]
0
0
Italy
Query!
State/province [144]
0
0
Lombardia
Query!
Country [145]
0
0
Italy
Query!
State/province [145]
0
0
Piemonte
Query!
Country [146]
0
0
Italy
Query!
State/province [146]
0
0
Toscana
Query!
Country [147]
0
0
Italy
Query!
State/province [147]
0
0
Umbria
Query!
Country [148]
0
0
Japan
Query!
State/province [148]
0
0
Aichi
Query!
Country [149]
0
0
Japan
Query!
State/province [149]
0
0
Chiba
Query!
Country [150]
0
0
Japan
Query!
State/province [150]
0
0
Ehime
Query!
Country [151]
0
0
Japan
Query!
State/province [151]
0
0
Fukuoka
Query!
Country [152]
0
0
Japan
Query!
State/province [152]
0
0
Fukushima
Query!
Country [153]
0
0
Japan
Query!
State/province [153]
0
0
Hiroshima
Query!
Country [154]
0
0
Japan
Query!
State/province [154]
0
0
Hokkaido
Query!
Country [155]
0
0
Japan
Query!
State/province [155]
0
0
Hyogo
Query!
Country [156]
0
0
Japan
Query!
State/province [156]
0
0
Ibaraki
Query!
Country [157]
0
0
Japan
Query!
State/province [157]
0
0
Kagoshima
Query!
Country [158]
0
0
Japan
Query!
State/province [158]
0
0
Kanagawa
Query!
Country [159]
0
0
Japan
Query!
State/province [159]
0
0
Kyoto
Query!
Country [160]
0
0
Japan
Query!
State/province [160]
0
0
Okayama
Query!
Country [161]
0
0
Japan
Query!
State/province [161]
0
0
Okinawa
Query!
Country [162]
0
0
Japan
Query!
State/province [162]
0
0
Osaka
Query!
Country [163]
0
0
Japan
Query!
State/province [163]
0
0
Saitama
Query!
Country [164]
0
0
Japan
Query!
State/province [164]
0
0
Shizuoka
Query!
Country [165]
0
0
Japan
Query!
State/province [165]
0
0
Tokyo
Query!
Country [166]
0
0
Korea, Republic of
Query!
State/province [166]
0
0
Cheongju-si
Query!
Country [167]
0
0
Korea, Republic of
Query!
State/province [167]
0
0
Dongnam-gu, Cheonan-si
Query!
Country [168]
0
0
Korea, Republic of
Query!
State/province [168]
0
0
Goyang-si
Query!
Country [169]
0
0
Korea, Republic of
Query!
State/province [169]
0
0
Gyeonggi-do
Query!
Country [170]
0
0
Korea, Republic of
Query!
State/province [170]
0
0
Incheon
Query!
Country [171]
0
0
Korea, Republic of
Query!
State/province [171]
0
0
Seongnam-si
Query!
Country [172]
0
0
Korea, Republic of
Query!
State/province [172]
0
0
Seoul
Query!
Country [173]
0
0
Korea, Republic of
Query!
State/province [173]
0
0
Suwon City
Query!
Country [174]
0
0
Korea, Republic of
Query!
State/province [174]
0
0
Ulsan
Query!
Country [175]
0
0
Korea, Republic of
Query!
State/province [175]
0
0
Wonju
Query!
Country [176]
0
0
Mexico
Query!
State/province [176]
0
0
Mexico CITY (federal District)
Query!
Country [177]
0
0
Mexico
Query!
State/province [177]
0
0
Nuevo LEON
Query!
Country [178]
0
0
Mexico
Query!
State/province [178]
0
0
Oaxaca
Query!
Country [179]
0
0
Mexico
Query!
State/province [179]
0
0
SAN LUIS Potosi
Query!
Country [180]
0
0
Mexico
Query!
State/province [180]
0
0
Yucatan
Query!
Country [181]
0
0
Mexico
Query!
State/province [181]
0
0
Mexico City
Query!
Country [182]
0
0
Peru
Query!
State/province [182]
0
0
Arequipa
Query!
Country [183]
0
0
Peru
Query!
State/province [183]
0
0
Lima
Query!
Country [184]
0
0
Poland
Query!
State/province [184]
0
0
?ód?
Query!
Country [185]
0
0
Poland
Query!
State/province [185]
0
0
Poznan
Query!
Country [186]
0
0
Poland
Query!
State/province [186]
0
0
Warszawa
Query!
Country [187]
0
0
Romania
Query!
State/province [187]
0
0
Bucharest
Query!
Country [188]
0
0
Romania
Query!
State/province [188]
0
0
Cluj Napoca
Query!
Country [189]
0
0
Romania
Query!
State/province [189]
0
0
Craiova
Query!
Country [190]
0
0
Russian Federation
Query!
State/province [190]
0
0
Adygeja
Query!
Country [191]
0
0
Russian Federation
Query!
State/province [191]
0
0
Arhangelsk
Query!
Country [192]
0
0
Russian Federation
Query!
State/province [192]
0
0
Baskortostan
Query!
Country [193]
0
0
Russian Federation
Query!
State/province [193]
0
0
Jaroslavl
Query!
Country [194]
0
0
Russian Federation
Query!
State/province [194]
0
0
Krasnodar
Query!
Country [195]
0
0
Russian Federation
Query!
State/province [195]
0
0
Kurgan
Query!
Country [196]
0
0
Russian Federation
Query!
State/province [196]
0
0
Mordovija
Query!
Country [197]
0
0
Russian Federation
Query!
State/province [197]
0
0
Moskovskaja Oblast
Query!
Country [198]
0
0
Russian Federation
Query!
State/province [198]
0
0
Niznij Novgorod
Query!
Country [199]
0
0
Russian Federation
Query!
State/province [199]
0
0
Rostov
Query!
Country [200]
0
0
Russian Federation
Query!
State/province [200]
0
0
Sankt Petersburg
Query!
Country [201]
0
0
Russian Federation
Query!
State/province [201]
0
0
Stavropol
Query!
Country [202]
0
0
Russian Federation
Query!
State/province [202]
0
0
Irkutsk
Query!
Country [203]
0
0
Russian Federation
Query!
State/province [203]
0
0
Ivanovo
Query!
Country [204]
0
0
Russian Federation
Query!
State/province [204]
0
0
Novgorod Veliky
Query!
Country [205]
0
0
Russian Federation
Query!
State/province [205]
0
0
Omsk
Query!
Country [206]
0
0
Russian Federation
Query!
State/province [206]
0
0
Samara
Query!
Country [207]
0
0
Russian Federation
Query!
State/province [207]
0
0
Saratov
Query!
Country [208]
0
0
Russian Federation
Query!
State/province [208]
0
0
Volgograd
Query!
Country [209]
0
0
Singapore
Query!
State/province [209]
0
0
Singapore
Query!
Country [210]
0
0
Spain
Query!
State/province [210]
0
0
Barcelona
Query!
Country [211]
0
0
Spain
Query!
State/province [211]
0
0
Cadiz
Query!
Country [212]
0
0
Spain
Query!
State/province [212]
0
0
Castellon
Query!
Country [213]
0
0
Spain
Query!
State/province [213]
0
0
Islas Baleares
Query!
Country [214]
0
0
Spain
Query!
State/province [214]
0
0
LA Coruña
Query!
Country [215]
0
0
Spain
Query!
State/province [215]
0
0
Madrid
Query!
Country [216]
0
0
Spain
Query!
State/province [216]
0
0
Pontevedra
Query!
Country [217]
0
0
Spain
Query!
State/province [217]
0
0
Tarragona
Query!
Country [218]
0
0
Spain
Query!
State/province [218]
0
0
Tenerife
Query!
Country [219]
0
0
Spain
Query!
State/province [219]
0
0
Burgos
Query!
Country [220]
0
0
Spain
Query!
State/province [220]
0
0
Caceres
Query!
Country [221]
0
0
Spain
Query!
State/province [221]
0
0
Jaen
Query!
Country [222]
0
0
Spain
Query!
State/province [222]
0
0
Leon
Query!
Country [223]
0
0
Spain
Query!
State/province [223]
0
0
Malaga
Query!
Country [224]
0
0
Spain
Query!
State/province [224]
0
0
Murcia
Query!
Country [225]
0
0
Spain
Query!
State/province [225]
0
0
Sevilla
Query!
Country [226]
0
0
Spain
Query!
State/province [226]
0
0
Valencia
Query!
Country [227]
0
0
Spain
Query!
State/province [227]
0
0
Zaragoza
Query!
Country [228]
0
0
Switzerland
Query!
State/province [228]
0
0
Aarau
Query!
Country [229]
0
0
Switzerland
Query!
State/province [229]
0
0
Lausanne
Query!
Country [230]
0
0
Switzerland
Query!
State/province [230]
0
0
Zürich
Query!
Country [231]
0
0
Taiwan
Query!
State/province [231]
0
0
Changhua
Query!
Country [232]
0
0
Taiwan
Query!
State/province [232]
0
0
Kaoshiung City
Query!
Country [233]
0
0
Taiwan
Query!
State/province [233]
0
0
Kaoshiung
Query!
Country [234]
0
0
Taiwan
Query!
State/province [234]
0
0
Liuying Township
Query!
Country [235]
0
0
Taiwan
Query!
State/province [235]
0
0
Tainan
Query!
Country [236]
0
0
Taiwan
Query!
State/province [236]
0
0
Taipei City
Query!
Country [237]
0
0
Taiwan
Query!
State/province [237]
0
0
Taipei
Query!
Country [238]
0
0
Taiwan
Query!
State/province [238]
0
0
Taoyuan City
Query!
Country [239]
0
0
Thailand
Query!
State/province [239]
0
0
Bangkok
Query!
Country [240]
0
0
Thailand
Query!
State/province [240]
0
0
Hat Yai
Query!
Country [241]
0
0
Thailand
Query!
State/province [241]
0
0
Khon Kaen
Query!
Country [242]
0
0
Thailand
Query!
State/province [242]
0
0
Muang Lampang
Query!
Country [243]
0
0
Thailand
Query!
State/province [243]
0
0
Patumwan
Query!
Country [244]
0
0
Turkey
Query!
State/province [244]
0
0
Adana
Query!
Country [245]
0
0
Turkey
Query!
State/province [245]
0
0
Bursa
Query!
Country [246]
0
0
Turkey
Query!
State/province [246]
0
0
Izmir
Query!
Country [247]
0
0
Turkey
Query!
State/province [247]
0
0
Mersin
Query!
Country [248]
0
0
Turkey
Query!
State/province [248]
0
0
Samsun
Query!
Country [249]
0
0
Ukraine
Query!
State/province [249]
0
0
Katerynoslav Governorate
Query!
Country [250]
0
0
Ukraine
Query!
State/province [250]
0
0
Kharkiv Governorate
Query!
Country [251]
0
0
Ukraine
Query!
State/province [251]
0
0
KIEV Governorate
Query!
Country [252]
0
0
Ukraine
Query!
State/province [252]
0
0
Podolia Governorate
Query!
Country [253]
0
0
Ukraine
Query!
State/province [253]
0
0
Chernigiv
Query!
Country [254]
0
0
Ukraine
Query!
State/province [254]
0
0
Chernivtsi
Query!
Country [255]
0
0
Ukraine
Query!
State/province [255]
0
0
Dnipropetrovsk
Query!
Country [256]
0
0
Ukraine
Query!
State/province [256]
0
0
Kirovograd
Query!
Country [257]
0
0
Ukraine
Query!
State/province [257]
0
0
Kryvyi Rih
Query!
Country [258]
0
0
Ukraine
Query!
State/province [258]
0
0
Lutsk
Query!
Country [259]
0
0
Ukraine
Query!
State/province [259]
0
0
Lviv
Query!
Country [260]
0
0
Ukraine
Query!
State/province [260]
0
0
Odesa
Query!
Country [261]
0
0
Ukraine
Query!
State/province [261]
0
0
Sumy
Query!
Country [262]
0
0
Ukraine
Query!
State/province [262]
0
0
Uzhgorod
Query!
Country [263]
0
0
Ukraine
Query!
State/province [263]
0
0
Zaporizhzhya
Query!
Country [264]
0
0
United Kingdom
Query!
State/province [264]
0
0
Edinburgh
Query!
Country [265]
0
0
United Kingdom
Query!
State/province [265]
0
0
Huddersfield
Query!
Country [266]
0
0
United Kingdom
Query!
State/province [266]
0
0
Leeds
Query!
Country [267]
0
0
United Kingdom
Query!
State/province [267]
0
0
London
Query!
Country [268]
0
0
United Kingdom
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Manchester
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Country [269]
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United Kingdom
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Nottingham
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Country [270]
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United Kingdom
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Stoke-On-Trent
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Other collaborator category [1]
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Other
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Breast International Group
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Other
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Alliance Foundation Trials (AFT)
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Other
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Institut Jules Bordet/Clinical Trials Support Unit (IJB/CTSU)
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Commercial sector/Industry
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Frontier Science & Technology Research Foundation, Inc.
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Ethics approval
Ethics application status
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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)
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03498716
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Clinical Trials
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Hoffmann-La Roche
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03498716
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