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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03498716
Registration number
NCT03498716
Ethics application status
Date submitted
28/02/2018
Date registered
17/04/2018
Date last updated
21/08/2024
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 was defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in the axilla, regional lymph nodes, chest wall, \&/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer; Contralateral invasive breast cancer; Distant recurrence (evidence of breast cancer in any anatomic site \[other than the sites mentioned\]) that has either been histologically confirmed \&/or clinically/radiographically diagnosed as recurrent invasive breast cancer; \& Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
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Timepoint [1]
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From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years)
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Secondary outcome [1]
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Invasive Disease-Free Survival (iDFS) in the Subpopulation With Programmed Death-ligand 1 (PD-L1) Selected Tumor Status (IC1/2/3)
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Assessment method [1]
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iDFS = the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer, Contralateral invasive breast cancer, Distant recurrence (i.e., evidence of breast cancer in any anatomic site \[other than the sites mentioned\]) that has either been histologically confirmed and/or clinically/radiographically diagnosed as recurrent invasive breast cancer and Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
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Timepoint [1]
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From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years)
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Secondary outcome [2]
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Invasive Disease-Free Survival (iDFS) in the Node Positive Subpopulation
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Assessment method [2]
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iDFS = the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer; Contralateral invasive breast cancer; Distant recurrence (evidence of breast cancer in any anatomic site \[other than the sites mentioned\]) that has either been histologically confirmed and/or clinically/radiographically diagnosed as recurrent invasive breast cancer; and Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
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Timepoint [2]
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From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years)
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Secondary outcome [3]
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Overall Survival (OS)
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Assessment method [3]
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Overall Survival (OS) is defined as the time from randomization to the date of death due to any cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
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Timepoint [3]
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From randomization up to death from any cause (up to 5 years)
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Secondary outcome [4]
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Invasive Disease-Free Survival (iDFS) Including Second Primary Non-Breast Invasive Cancer
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Assessment method [4]
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iDFS = the time from randomization until the date of first occurrence of one of the events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in axilla, regional lymph nodes, chest wall, \&/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer; Second primary non-breast invasive cancer; Contralateral invasive breast cancer; Distant recurrence (i.e., evidence of breast cancer in any anatomic site \[other than sites mentioned\]) that has either been histologically confirmed \&/or clinically/radiographically diagnosed as recurrent invasive breast cancer; Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
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Timepoint [4]
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From randomization up to death from any cause (up to 5 years)
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Secondary outcome [5]
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Recurrence-Free Interval (RFI)
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Assessment method [5]
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Recurrence-Free Interval (RFI) was defined as the time from randomization to the first occurrence of any recurrence (local, regional \[including invasive ipsilateral tumor and invasive locoregional tumor\], or distant), as determined by investigators. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis, participants with no events who died, or participants with no post-baseline information were censored.
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Timepoint [5]
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From randomization up to 5 years
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Secondary outcome [6]
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Distant Recurrence-Free Interval (DRFI)
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Assessment method [6]
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Distant Recurrence-Free Interval (DRFI) was defined as the time from randomization to the distant breast cancer recurrence. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis, participants with no events who died, or participants with no post-baseline information were censored.
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Timepoint [6]
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From randomization up to 5 years
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Secondary outcome [7]
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Disease-Free Survival (DFS)
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Assessment method [7]
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Disease-Free Survival (DFS) was defined as the time from randomization to the first occurrence of disease recurrence or death from any cause. DFS events include: Ipsilateral invasive breast tumor recurrence; Ipsilateral local-regional invasive breast cancer recurrence; Distant recurrence that has either been histologically confirmed or clinically diagnosed as recurrent invasive breast cancer; Contralateral invasive breast cancer; Ipsilateral or contralateral DCIS; Second primary non-breast invasive cancer; Death attributable to any cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
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Timepoint [7]
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From randomization up to first disease recurrence or death from any cause (up to 5 years)
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Secondary outcome [8]
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Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Patient-reported Function (Role Functioning [Q6, Q7])
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Assessment method [8]
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The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. For the role functioning scale, participant responses to the 2 questions "Q6: Were you limited in doing either your work or daily activities" and "Q7: Were you limited in pursuing your hobbies or other leisure time activities" were scored on a 4-point scale (1=Not at All to 4=Very Much). The scores were linearly transformed on a scale of 0 to 100, with a low score indicating better functioning. Negative change from baseline indicated improvement.
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Timepoint [8]
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Baseline (Cycle 1 Day 1), Day 1 of Cycles 4, 6, 8, 10, 12, 14 & 16; end of treatment/discontinuation (approximately at Day 351); Follow up: Months 3 to 48 (Total duration is up to 5 years); Cycles 1-5= 28 day cycles; Cycles 6-16: 21 day cycles
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Secondary outcome [9]
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Change From Baseline in EORTC QLQ-C30 Patient-reported Function (Physical Functioning [Q1-Q5])
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Assessment method [9]
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The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. For the physical functioning scale, participant responses to 5 questions about daily activities (strenuous activities, long walks, short walks, bed/chair rest \& needing help with eating, dressing, washing themselves, or using the toilet) were scored on a 4-point scale (1=Not at All to 4=Very Much). The scores were linearly transformed on a scale of 0 to 100, with a high score indicating worst functioning. Negative change from baseline indicated improvement in functioning.
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Timepoint [9]
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Baseline (Cycle 1 Day 1), Day 1 of Cycles 4, 6, 8, 10, 12, 14 & 16; end of treatment/discontinuation (approximately at Day 351); Follow up: Months 3 to 48 (Total duration is up to 5 years); Cycles 1-5= 28 day cycles; Cycles 6-16: 21 day cycles
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Secondary outcome [10]
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Change From Baseline in EORTC QLQ-C30 Global Health Status (GHS) [Q29] and Health-Related Quality of Life (HRQoL) [Q30] Combined Score
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Assessment method [10]
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The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (Q29:GHS; "How would you rate your overall health during the past week?") and Quality of Life (Q30: QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better outcome. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement.
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Timepoint [10]
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Baseline (Cycle 1 Day 1), Day 1 of Cycles 4, 6, 8, 10, 12, 14 & 16; end of treatment/discontinuation (approximately 351 days); Follow up: Months 3 to 48 (Total duration is up to 5 years); Cycles 1-5= 28 day cycles; Cycles 6-16: 21 day cycles
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Secondary outcome [11]
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Number of Participants With Adverse Events (AE)
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Assessment method [11]
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An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs are reported based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0.
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Timepoint [11]
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Up to 5 years
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Secondary outcome [12]
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Serum Concentration of Atezolizumab
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Assessment method [12]
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Timepoint [12]
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Postdose Day 1 of Cycle 1; Predose Day 1 of Cycles 2, 3, and 4; Predose Cycles 6, 10, and 14; Predose Day 2 of Cycle 16; Cycles 1-5= 28-day cycles; Cycles 6-16: 21-day cycles
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Secondary outcome [13]
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Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
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Assessment method [13]
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Baseline evaluable participant= participant with an ADA assay result from a baseline sample(s). Post-baseline evaluable participant= participant with an ADA assay result from at least one postbaseline sample.
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Timepoint [13]
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Up to 5 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
Stopped early
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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
2199
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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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Recruitment hospital [2]
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Lismore Base Hospital - Lismore
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Macquarie University Hospital - Macquarie Park
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Sydney Adventist Hospital - Wahroonga
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Recruitment hospital [5]
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Icon Cancer Care Wesley - Auchenflower
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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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Recruitment hospital [9]
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Icon Cancer Foundation; Icon Cancer Care Southport - Southport
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Recruitment hospital [10]
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Princess Alexandra Hospital; Cancer Trials Unit - Woolloongabba
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Recruitment hospital [11]
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Royal Adelaide Hospital; Cancer Centre - Adelaide
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Recruitment hospital [12]
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Ashford Cancer Center Research - Kurralta Park
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Recruitment hospital [13]
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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 [15]
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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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2113 - Macquarie Park
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Recruitment postcode(s) [4]
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2076 - Wahroonga
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Recruitment postcode(s) [5]
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4066 - Auchenflower
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Recruitment postcode(s) [6]
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4032 - Chermside
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Recruitment postcode(s) [7]
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4101 - South Brisbane
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Recruitment postcode(s) [8]
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4215 - Southport
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Recruitment postcode(s) [9]
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4102 - Woolloongabba
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Recruitment postcode(s) [10]
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5000 - Adelaide
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Recruitment postcode(s) [11]
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5037 - Kurralta Park
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Recruitment postcode(s) [12]
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3168 - Clayton
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Recruitment postcode(s) [13]
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3084 - Heidelberg
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Recruitment postcode(s) [14]
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3135 - Ringwood East
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Recruitment outside Australia
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United States of America
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California
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Florida
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Illinois
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New York
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Tennessee
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Argentina
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Berazategui
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Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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Cordoba
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Argentina
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Jujuy
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Argentina
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La Rioja
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Rosario
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San Miguel de Tucuman
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Viedma
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Austria
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Innsbruck
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Austria
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Linz
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Austria
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Salzburg
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Vienna
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Austria
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Vöcklabruck
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Austria
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Austria
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Wien
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Brasschaat
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Bruxelles
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Liège
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Namur
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Sint Niklaas
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BA
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Brazil
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Brazil
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RJ
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Brazil
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RS
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Brazil
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SC
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Brazil
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SP
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China
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Beijing
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China
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Changchun City
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China
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Changchun
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China
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Chengdu
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0
0
China
Query!
State/province [47]
0
0
Chongqing
Query!
Country [48]
0
0
China
Query!
State/province [48]
0
0
Fuzhou City
Query!
Country [49]
0
0
China
Query!
State/province [49]
0
0
Fuzhou
Query!
Country [50]
0
0
China
Query!
State/province [50]
0
0
Guangzhou
Query!
Country [51]
0
0
China
Query!
State/province [51]
0
0
Hangzhou
Query!
Country [52]
0
0
China
Query!
State/province [52]
0
0
Harbin
Query!
Country [53]
0
0
China
Query!
State/province [53]
0
0
Jinan
Query!
Country [54]
0
0
China
Query!
State/province [54]
0
0
Luoyang City
Query!
Country [55]
0
0
China
Query!
State/province [55]
0
0
Nanjing City
Query!
Country [56]
0
0
China
Query!
State/province [56]
0
0
Shanghai City
Query!
Country [57]
0
0
China
Query!
State/province [57]
0
0
Shanghai
Query!
Country [58]
0
0
China
Query!
State/province [58]
0
0
Shenzhen City
Query!
Country [59]
0
0
China
Query!
State/province [59]
0
0
Shijiazhuang
Query!
Country [60]
0
0
China
Query!
State/province [60]
0
0
Wuhan City
Query!
Country [61]
0
0
China
Query!
State/province [61]
0
0
Wuhan
Query!
Country [62]
0
0
China
Query!
State/province [62]
0
0
Xi'an City
Query!
Country [63]
0
0
China
Query!
State/province [63]
0
0
Zhejiang
Query!
Country [64]
0
0
China
Query!
State/province [64]
0
0
Zhengzhou
Query!
Country [65]
0
0
Czechia
Query!
State/province [65]
0
0
Horovice
Query!
Country [66]
0
0
Czechia
Query!
State/province [66]
0
0
Praha 2
Query!
Country [67]
0
0
Czechia
Query!
State/province [67]
0
0
Zlin
Query!
Country [68]
0
0
Denmark
Query!
State/province [68]
0
0
Herlev
Query!
Country [69]
0
0
Denmark
Query!
State/province [69]
0
0
Odense C
Query!
Country [70]
0
0
Denmark
Query!
State/province [70]
0
0
Vejle
Query!
Country [71]
0
0
France
Query!
State/province [71]
0
0
Ars-Laquenexy
Query!
Country [72]
0
0
France
Query!
State/province [72]
0
0
Avignon
Query!
Country [73]
0
0
France
Query!
State/province [73]
0
0
Beauvais
Query!
Country [74]
0
0
France
Query!
State/province [74]
0
0
Besançon
Query!
Country [75]
0
0
France
Query!
State/province [75]
0
0
Bordeaux
Query!
Country [76]
0
0
France
Query!
State/province [76]
0
0
Bourg-en- Bresse Cedex
Query!
Country [77]
0
0
France
Query!
State/province [77]
0
0
Brest
Query!
Country [78]
0
0
France
Query!
State/province [78]
0
0
Caen
Query!
Country [79]
0
0
France
Query!
State/province [79]
0
0
Cholet
Query!
Country [80]
0
0
France
Query!
State/province [80]
0
0
Compiegne
Query!
Country [81]
0
0
France
Query!
State/province [81]
0
0
Contamine Sur Arve
Query!
Country [82]
0
0
France
Query!
State/province [82]
0
0
Dijon
Query!
Country [83]
0
0
France
Query!
State/province [83]
0
0
La Roche Sur Yon
Query!
Country [84]
0
0
France
Query!
State/province [84]
0
0
Limoges
Query!
Country [85]
0
0
France
Query!
State/province [85]
0
0
Lorient
Query!
Country [86]
0
0
France
Query!
State/province [86]
0
0
Lyon
Query!
Country [87]
0
0
France
Query!
State/province [87]
0
0
Marseille
Query!
Country [88]
0
0
France
Query!
State/province [88]
0
0
Montpellier
Query!
Country [89]
0
0
France
Query!
State/province [89]
0
0
Nantes
Query!
Country [90]
0
0
France
Query!
State/province [90]
0
0
Nice
Query!
Country [91]
0
0
France
Query!
State/province [91]
0
0
Pringy
Query!
Country [92]
0
0
France
Query!
State/province [92]
0
0
Quimper
Query!
Country [93]
0
0
France
Query!
State/province [93]
0
0
Reims
Query!
Country [94]
0
0
France
Query!
State/province [94]
0
0
Rouen
Query!
Country [95]
0
0
France
Query!
State/province [95]
0
0
St Priest en Jarez CEDEX
Query!
Country [96]
0
0
France
Query!
State/province [96]
0
0
Strasbourg
Query!
Country [97]
0
0
France
Query!
State/province [97]
0
0
Thonon Les Bains
Query!
Country [98]
0
0
France
Query!
State/province [98]
0
0
Toulouse
Query!
Country [99]
0
0
France
Query!
State/province [99]
0
0
Tours
Query!
Country [100]
0
0
France
Query!
State/province [100]
0
0
Valence
Query!
Country [101]
0
0
France
Query!
State/province [101]
0
0
Vandoeuvre-Les-Nancy
Query!
Country [102]
0
0
France
Query!
State/province [102]
0
0
Villejuif
Query!
Country [103]
0
0
Germany
Query!
State/province [103]
0
0
Berlin
Query!
Country [104]
0
0
Germany
Query!
State/province [104]
0
0
Dortmund
Query!
Country [105]
0
0
Germany
Query!
State/province [105]
0
0
Dresden
Query!
Country [106]
0
0
Germany
Query!
State/province [106]
0
0
Erfurt
Query!
Country [107]
0
0
Germany
Query!
State/province [107]
0
0
Gütersloh
Query!
Country [108]
0
0
Germany
Query!
State/province [108]
0
0
Hamburg
Query!
Country [109]
0
0
Germany
Query!
State/province [109]
0
0
Hildesheim
Query!
Country [110]
0
0
Germany
Query!
State/province [110]
0
0
Karlsruhe
Query!
Country [111]
0
0
Germany
Query!
State/province [111]
0
0
Köln
Query!
Country [112]
0
0
Germany
Query!
State/province [112]
0
0
Ludwigsburg
Query!
Country [113]
0
0
Germany
Query!
State/province [113]
0
0
Mainz
Query!
Country [114]
0
0
Germany
Query!
State/province [114]
0
0
Mayen
Query!
Country [115]
0
0
Germany
Query!
State/province [115]
0
0
Memmingen
Query!
Country [116]
0
0
Germany
Query!
State/province [116]
0
0
Minden
Query!
Country [117]
0
0
Germany
Query!
State/province [117]
0
0
Mönchengladbach
Query!
Country [118]
0
0
Germany
Query!
State/province [118]
0
0
München
Query!
Country [119]
0
0
Germany
Query!
State/province [119]
0
0
Neumarkt i.d.OPf.
Query!
Country [120]
0
0
Germany
Query!
State/province [120]
0
0
Offenbach
Query!
Country [121]
0
0
Germany
Query!
State/province [121]
0
0
Stendal
Query!
Country [122]
0
0
Germany
Query!
State/province [122]
0
0
Stralsund
Query!
Country [123]
0
0
Germany
Query!
State/province [123]
0
0
Tübingen
Query!
Country [124]
0
0
Germany
Query!
State/province [124]
0
0
Weinheim
Query!
Country [125]
0
0
Germany
Query!
State/province [125]
0
0
Witten
Query!
Country [126]
0
0
Germany
Query!
State/province [126]
0
0
Worms
Query!
Country [127]
0
0
Hong Kong
Query!
State/province [127]
0
0
Hong Kong
Query!
Country [128]
0
0
Hong Kong
Query!
State/province [128]
0
0
Kowloon
Query!
Country [129]
0
0
Hungary
Query!
State/province [129]
0
0
Budapest
Query!
Country [130]
0
0
Hungary
Query!
State/province [130]
0
0
Miskolc
Query!
Country [131]
0
0
Hungary
Query!
State/province [131]
0
0
Pécs
Query!
Country [132]
0
0
Ireland
Query!
State/province [132]
0
0
Dublin
Query!
Country [133]
0
0
Israel
Query!
State/province [133]
0
0
Jerusalem
Query!
Country [134]
0
0
Israel
Query!
State/province [134]
0
0
Kfar Sava
Query!
Country [135]
0
0
Israel
Query!
State/province [135]
0
0
Petach Tikva
Query!
Country [136]
0
0
Israel
Query!
State/province [136]
0
0
Ramat Gan
Query!
Country [137]
0
0
Italy
Query!
State/province [137]
0
0
Abruzzo
Query!
Country [138]
0
0
Italy
Query!
State/province [138]
0
0
Emilia-Romagna
Query!
Country [139]
0
0
Italy
Query!
State/province [139]
0
0
Friuli-Venezia Giulia
Query!
Country [140]
0
0
Italy
Query!
State/province [140]
0
0
Lazio
Query!
Country [141]
0
0
Italy
Query!
State/province [141]
0
0
Liguria
Query!
Country [142]
0
0
Italy
Query!
State/province [142]
0
0
Lombardia
Query!
Country [143]
0
0
Italy
Query!
State/province [143]
0
0
Piemonte
Query!
Country [144]
0
0
Italy
Query!
State/province [144]
0
0
Toscana
Query!
Country [145]
0
0
Italy
Query!
State/province [145]
0
0
Umbria
Query!
Country [146]
0
0
Japan
Query!
State/province [146]
0
0
Aichi
Query!
Country [147]
0
0
Japan
Query!
State/province [147]
0
0
Chiba
Query!
Country [148]
0
0
Japan
Query!
State/province [148]
0
0
Ehime
Query!
Country [149]
0
0
Japan
Query!
State/province [149]
0
0
Fukuoka
Query!
Country [150]
0
0
Japan
Query!
State/province [150]
0
0
Hiroshima
Query!
Country [151]
0
0
Japan
Query!
State/province [151]
0
0
Hokkaido
Query!
Country [152]
0
0
Japan
Query!
State/province [152]
0
0
Hyogo
Query!
Country [153]
0
0
Japan
Query!
State/province [153]
0
0
Ibaraki
Query!
Country [154]
0
0
Japan
Query!
State/province [154]
0
0
Kagoshima
Query!
Country [155]
0
0
Japan
Query!
State/province [155]
0
0
Kanagawa
Query!
Country [156]
0
0
Japan
Query!
State/province [156]
0
0
Kyoto
Query!
Country [157]
0
0
Japan
Query!
State/province [157]
0
0
Miyagi
Query!
Country [158]
0
0
Japan
Query!
State/province [158]
0
0
Okayama
Query!
Country [159]
0
0
Japan
Query!
State/province [159]
0
0
Okinawa
Query!
Country [160]
0
0
Japan
Query!
State/province [160]
0
0
Osaka
Query!
Country [161]
0
0
Japan
Query!
State/province [161]
0
0
Saitama
Query!
Country [162]
0
0
Japan
Query!
State/province [162]
0
0
Shizuoka
Query!
Country [163]
0
0
Japan
Query!
State/province [163]
0
0
Tokyo
Query!
Country [164]
0
0
Korea, Republic of
Query!
State/province [164]
0
0
Cheongju si
Query!
Country [165]
0
0
Korea, Republic of
Query!
State/province [165]
0
0
Dongnam-gu, Cheonan-si
Query!
Country [166]
0
0
Korea, Republic of
Query!
State/province [166]
0
0
Goyang-si
Query!
Country [167]
0
0
Korea, Republic of
Query!
State/province [167]
0
0
Gyeonggi-do
Query!
Country [168]
0
0
Korea, Republic of
Query!
State/province [168]
0
0
Incheon
Query!
Country [169]
0
0
Korea, Republic of
Query!
State/province [169]
0
0
Seongnam-si
Query!
Country [170]
0
0
Korea, Republic of
Query!
State/province [170]
0
0
Seoul
Query!
Country [171]
0
0
Korea, Republic of
Query!
State/province [171]
0
0
Suwon City
Query!
Country [172]
0
0
Korea, Republic of
Query!
State/province [172]
0
0
Ulsan
Query!
Country [173]
0
0
Korea, Republic of
Query!
State/province [173]
0
0
Wonju
Query!
Country [174]
0
0
Mexico
Query!
State/province [174]
0
0
Mexico CITY (federal District)
Query!
Country [175]
0
0
Mexico
Query!
State/province [175]
0
0
Nuevo LEON
Query!
Country [176]
0
0
Mexico
Query!
State/province [176]
0
0
Oaxaca
Query!
Country [177]
0
0
Mexico
Query!
State/province [177]
0
0
SAN LUIS Potosi
Query!
Country [178]
0
0
Mexico
Query!
State/province [178]
0
0
Yucatan
Query!
Country [179]
0
0
Mexico
Query!
State/province [179]
0
0
Mexico City
Query!
Country [180]
0
0
Peru
Query!
State/province [180]
0
0
Arequipa
Query!
Country [181]
0
0
Peru
Query!
State/province [181]
0
0
Lima
Query!
Country [182]
0
0
Poland
Query!
State/province [182]
0
0
?ód?
Query!
Country [183]
0
0
Poland
Query!
State/province [183]
0
0
Poznan
Query!
Country [184]
0
0
Poland
Query!
State/province [184]
0
0
Warszawa
Query!
Country [185]
0
0
Romania
Query!
State/province [185]
0
0
Bucharest
Query!
Country [186]
0
0
Romania
Query!
State/province [186]
0
0
Cluj Napoca
Query!
Country [187]
0
0
Romania
Query!
State/province [187]
0
0
Craiova
Query!
Country [188]
0
0
Russian Federation
Query!
State/province [188]
0
0
Adygeja
Query!
Country [189]
0
0
Russian Federation
Query!
State/province [189]
0
0
Arhangelsk
Query!
Country [190]
0
0
Russian Federation
Query!
State/province [190]
0
0
Baskortostan
Query!
Country [191]
0
0
Russian Federation
Query!
State/province [191]
0
0
Jaroslavl
Query!
Country [192]
0
0
Russian Federation
Query!
State/province [192]
0
0
Krasnodar
Query!
Country [193]
0
0
Russian Federation
Query!
State/province [193]
0
0
Kurgan
Query!
Country [194]
0
0
Russian Federation
Query!
State/province [194]
0
0
Mordovija
Query!
Country [195]
0
0
Russian Federation
Query!
State/province [195]
0
0
Moskovskaja Oblast
Query!
Country [196]
0
0
Russian Federation
Query!
State/province [196]
0
0
Niznij Novgorod
Query!
Country [197]
0
0
Russian Federation
Query!
State/province [197]
0
0
Rostov
Query!
Country [198]
0
0
Russian Federation
Query!
State/province [198]
0
0
Sankt Petersburg
Query!
Country [199]
0
0
Russian Federation
Query!
State/province [199]
0
0
Stavropol
Query!
Country [200]
0
0
Russian Federation
Query!
State/province [200]
0
0
Irkutsk
Query!
Country [201]
0
0
Russian Federation
Query!
State/province [201]
0
0
Ivanovo
Query!
Country [202]
0
0
Russian Federation
Query!
State/province [202]
0
0
Novgorod Veliky
Query!
Country [203]
0
0
Russian Federation
Query!
State/province [203]
0
0
Omsk
Query!
Country [204]
0
0
Russian Federation
Query!
State/province [204]
0
0
Samara
Query!
Country [205]
0
0
Russian Federation
Query!
State/province [205]
0
0
Saratov
Query!
Country [206]
0
0
Russian Federation
Query!
State/province [206]
0
0
Volgograd
Query!
Country [207]
0
0
Singapore
Query!
State/province [207]
0
0
Singapore
Query!
Country [208]
0
0
Spain
Query!
State/province [208]
0
0
Barcelona
Query!
Country [209]
0
0
Spain
Query!
State/province [209]
0
0
Cadiz
Query!
Country [210]
0
0
Spain
Query!
State/province [210]
0
0
Castellon
Query!
Country [211]
0
0
Spain
Query!
State/province [211]
0
0
Islas Baleares
Query!
Country [212]
0
0
Spain
Query!
State/province [212]
0
0
LA Coruña
Query!
Country [213]
0
0
Spain
Query!
State/province [213]
0
0
Madrid
Query!
Country [214]
0
0
Spain
Query!
State/province [214]
0
0
Pontevedra
Query!
Country [215]
0
0
Spain
Query!
State/province [215]
0
0
Tarragona
Query!
Country [216]
0
0
Spain
Query!
State/province [216]
0
0
Tenerife
Query!
Country [217]
0
0
Spain
Query!
State/province [217]
0
0
Burgos
Query!
Country [218]
0
0
Spain
Query!
State/province [218]
0
0
Caceres
Query!
Country [219]
0
0
Spain
Query!
State/province [219]
0
0
Jaen
Query!
Country [220]
0
0
Spain
Query!
State/province [220]
0
0
Leon
Query!
Country [221]
0
0
Spain
Query!
State/province [221]
0
0
Malaga
Query!
Country [222]
0
0
Spain
Query!
State/province [222]
0
0
Murcia
Query!
Country [223]
0
0
Spain
Query!
State/province [223]
0
0
Sevilla
Query!
Country [224]
0
0
Spain
Query!
State/province [224]
0
0
Valencia
Query!
Country [225]
0
0
Spain
Query!
State/province [225]
0
0
Zaragoza
Query!
Country [226]
0
0
Switzerland
Query!
State/province [226]
0
0
Aarau
Query!
Country [227]
0
0
Switzerland
Query!
State/province [227]
0
0
Lausanne
Query!
Country [228]
0
0
Switzerland
Query!
State/province [228]
0
0
Zürich
Query!
Country [229]
0
0
Taiwan
Query!
State/province [229]
0
0
Changhua
Query!
Country [230]
0
0
Taiwan
Query!
State/province [230]
0
0
Kaoshiung City
Query!
Country [231]
0
0
Taiwan
Query!
State/province [231]
0
0
Kaoshiung
Query!
Country [232]
0
0
Taiwan
Query!
State/province [232]
0
0
Liuying Township
Query!
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Taiwan
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Tainan
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Taiwan
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Taipei City
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Taiwan
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Taipei
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Taiwan
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Taoyuan City
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Thailand
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Bangkok
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Thailand
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Hat Yai
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Thailand
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Khon Kaen
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Thailand
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Muang Lampang
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Thailand
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Patumwan
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Turkey
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Adana
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Turkey
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Bursa
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Turkey
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Izmir
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Turkey
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Mersin
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Turkey
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Samsun
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Ukraine
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Katerynoslav Governorate
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Ukraine
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KIEV Governorate
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Ukraine
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Podolia Governorate
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Ukraine
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Chernigiv
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Ukraine
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Chernivtsi
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Ukraine
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Dnipropetrovsk
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Ukraine
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Kirovograd
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Ukraine
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Kryvyi Rih
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Ukraine
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Lutsk
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Ukraine
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Lviv
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Ukraine
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Odesa
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Ukraine
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Sumy
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Ukraine
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Uzhgorod
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Ukraine
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Zaporizhzhya
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United Kingdom
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Edinburgh
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United Kingdom
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Huddersfield
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United Kingdom
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Leeds
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United Kingdom
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Manchester
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United Kingdom
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Nottingham
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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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Address
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Other collaborator category [1]
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Other
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Name [1]
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Breast International Group
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Other
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Name [2]
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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/study/NCT03498716
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Trial related presentations / publications
Perez-Garcia J, Soberino J, Racca F, Gion M, Stradella A, Cortes J. Atezolizumab in the treatment of metastatic triple-negative breast cancer. Expert Opin Biol Ther. 2020 Sep;20(9):981-989. doi: 10.1080/14712598.2020.1769063. Epub 2020 May 25.
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Public notes
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Contacts
Principal investigator
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Clinical Trials
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Address
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Hoffmann-La Roche
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/16/NCT03498716/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/16/NCT03498716/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03498716
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