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A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer (IMpassion031)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03197935
Recruitment Status : Active, not recruiting
First Posted : June 23, 2017
Results First Posted : June 2, 2021
Last Update Posted : December 9, 2021
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Triple-negative Breast Cancer
Interventions Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
Drug: Placebo
Drug: Nab-paclitaxel
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Filgrastim
Drug: Pegfilgrastim
Enrollment 333
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo and Chemotherapy Atezolizumab and Chemotherapy
Hide Arm/Group Description Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery. Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.
Period Title: Overall Study
Started 168 165
Completed 0 0
Not Completed 168 165
Reason Not Completed
Death due to any cause             9             7
Lost to Follow-up             0             3
Physician Decision             0             1
Withdrawal by Subject             11             7
On-Going in Study             147             146
Did not receive any study treatment             1             1
Arm/Group Title Placebo and Chemotherapy Atezolizumab and Chemotherapy Total
Hide Arm/Group Description Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery. Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy. Total of all reporting groups
Overall Number of Baseline Participants 168 165 333
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 168 participants 165 participants 333 participants
50.3  (13.2) 50.1  (11.6) 50.2  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 168 participants 165 participants 333 participants
Female
168
 100.0%
165
 100.0%
333
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 168 participants 165 participants 333 participants
Hispanic or Latino
47
  28.0%
45
  27.3%
92
  27.6%
Not Hispanic or Latino
114
  67.9%
114
  69.1%
228
  68.5%
Unknown or Not Reported
7
   4.2%
6
   3.6%
13
   3.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 168 participants 165 participants 333 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
41
  24.4%
47
  28.5%
88
  26.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
15
   8.9%
9
   5.5%
24
   7.2%
White
108
  64.3%
102
  61.8%
210
  63.1%
More than one race
0
   0.0%
4
   2.4%
4
   1.2%
Unknown or Not Reported
4
   2.4%
3
   1.8%
7
   2.1%
1.Primary Outcome
Title Number of Participants With Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population
Hide Description Number of participants with Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population. pCR is defined as eradication of invasive tumor from both breast and lymph nodes (ypT0/is ypN0). pCR was evaluated for each participant after neoadjuvant study treatment and surgery. Participants whose pCR assessment was missing will be counted as not achieving a pCR.
Time Frame After neoadjuvant study treatment and surgery, up to data cut-off on 03 ApriI 2020
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (full population) is defined as all randomized participants.
Arm/Group Title Placebo and Chemotherapy Atezolizumab and Chemotherapy
Hide Arm/Group Description:
Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.
Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.
Overall Number of Participants Analyzed 168 165
Measure Type: Number
Unit of Measure: Number of Participants
69 95
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo and Chemotherapy, Atezolizumab and Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0044
Comments (one-sided)
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in pCR
Estimated Value 16.50
Confidence Interval (2-Sided) 95%
5.91 to 27.10
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With pCR in Subpopulation With PD-L1-Positive Tumor Status (Tumor-infiltrating Immune Cell [IC] 1/2/3) Using AJCC Staging System
Hide Description Number of participants with Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in the subpopulation with programmed death-ligand1 (PD-L1)-positive tumor status(tumor-infiltrating immune cell [IC] IC1/2/3) . pCR is defined as eradication of invasive tumor from both breast and lymph nodes (ypT0/is ypN0). pCR was evaluated for each participant after neoadjuvant study treatment and surgery. Participants whose pCR assessment was missing will be counted as not achieving a pCR.
Time Frame After neoadjuvant study treatment and surgery, up to data cut-off on 03 ApriI 2020
Hide Outcome Measure Data
Hide Analysis Population Description
PD-L1-positive subpopulation is defined as participants in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization.
Arm/Group Title Placebo and Chemotherapy Atezolizumab and Chemotherapy
Hide Arm/Group Description:
Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.
Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.
Overall Number of Participants Analyzed 75 77
Measure Type: Number
Unit of Measure: Number of Participants
37 53
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo and Chemotherapy, Atezolizumab and Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0206
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in pCR
Estimated Value 19.50
Confidence Interval (2-Sided) 95%
4.17 to 34.83
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Event-Free Survival (EFS) in All Participants
Hide Description Event-free survival (EFS) defined as the time from randomization until documented disease recurrence, progression, or death from any cause in all participants. EFS events covered under "disease recurrence" will include local, regional, or distant recurrence and contralateral breast cancer. Ipsilateral or contralateral in situ disease and second primary non-breast cancers will not be counted as EFS events.
Time Frame Baseline up to approximately 63 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Event-Free Survival (EFS) in Subpopulation With PD-L1-Postive Tumor Status
Hide Description Event-free survival (EFS) defined as the time from randomization until documented disease recurrence, progression, or death from any cause in the subpopulation with PD-L1-positive tumor status. EFS events covered under "disease recurrence" will include local, regional, or distant recurrence and contralateral breast cancer. Ipsilateral or contralateral in situ disease and second primary non-breast cancers will not be counted as EFS events.
Time Frame Baseline up to approximately 63 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Disease-Free Survival (DFS) in All Participants Who Undergo Surgery
Hide Description Disease-free survival (DFS) defined as the time from surgery until documented disease recurrence or death from any cause in all patients (ITT population) who undergo surgery.
Time Frame Baseline up to approximately 63 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Disease-Free Survival (DFS) in Subpopulation of Participants With PD-L1-Positive Tumor Status Who Undergo Surgery
Hide Description Disease-free survival (DFS) defined as the time from surgery until documented disease recurrence or death from any cause in the subpopulation of participants with PD-L1-positive tumor status who undergo surgery.
Time Frame Baseline up to approximately 63 months
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Overall Survival (OS) in All Participants
Hide Description Overall survival (OS) defined as the time from randomization to the date of death from any cause in all participants.
Time Frame Baseline up to approximately 63 months
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Overall Survival (OS) in Subpopulation With PD-L1-Positive Tumor Status
Hide Description Overall survival (OS) defined as the time from randomization to the date of death from any cause in the subpopulation with PD-L1-positive tumor status.
Time Frame Baseline up to approximately 63 months
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30
Hide Description Mean score in function (role, physical) and global health status(GHS)/ health-related quality of life (HRQoL) by cycle and between treatment arms as assessed by the functional and HRQoL scales of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core30(QLQ C30). The EORTC QLQ-C30 includes five functional scales; a global health status (GHS)/quality of life (QoL) scale; and items measuring fatigue, pain, nausea and vomiting, dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial difficulties. The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms).
Time Frame Baseline (Cycle 1 Day 1), on Day 1 of every cycle (C) thereafter (C=28 days from C1 to 5, and 21 days from C6 to 16), at Study Drug Completion/Early Discontinuation, Survival Follow-Up Months 3, 6, 9, 12, 18 and 24 (up to approximately 63 months)
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30
Hide Description Mean change from baseline score in function (role, physical) andglobal health status(GHS)/ health-related quality of life (HRQoL) by cycle and between treatment arms as assessed by the functional and HRQoL scales of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core30(QLQ C30). Note: Cycle=C; Day=D.
Time Frame Baseline (Cycle 1 Day 1), and on Day 1 of every cycle (C) thereafter (C length=28 days from C1 to 5, and 21 days from C6 to 16), at Study Drug Completion/Early Termination, Survival Follow-Up Months 12, 18, and 24 (up to approximately 63 months)
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Percentage of Participants With Adverse Events (AEs)
Hide Description Percentage of participants with adverse events.
Time Frame Baseline up to approximately 63 months
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Minimum Observed Serum Atezolizumab Concentration (Cmin)
Hide Description Minimum observed serum atezolizumab concentration.
Time Frame Pre-dose on Day 1 of Cycles 2, 3, 4, 6, 8, 12, and 16 (cycle length = 28 days from Cycles 1 to 5, and 21 days from Cycles 6 to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic-evaluable population is defined as all participants who received any dose of atezolizumab and who have evaluable pharmacokinetic (PK) samples.
Arm/Group Title Atezolizumab and Chemotherapy
Hide Arm/Group Description:
Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.
Overall Number of Participants Analyzed 164
Mean (Standard Deviation)
Unit of Measure: µg/mL
Cycle 2 Day 1 142  (54.3)
Cycle 3 Day 1 189  (64.2)
Cycle 4 Day 1 207  (77.3)
Cycle 6 Day 1 78.7  (50.3)
Cycle 8 Day 1 204  (62.7)
Cycle 12 Day 1 267  (81.1)
Cycle 16 Day 1 303  (89.1)
13.Secondary Outcome
Title Maximum Observed Serum Atezolizumab Concentration (Cmax)
Hide Description Maximum observed atezolizumab concentration (Cmax).
Time Frame Day 1 of Cycle 1 post dose (cycle length = 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic-evaluable population is defined as all participants who received any dose of atezolizumab and who have evaluable pharmacokinetic (PK) samples.
Arm/Group Title Atezolizumab and Chemotherapy
Hide Arm/Group Description:
Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.
Overall Number of Participants Analyzed 164
Mean (Standard Deviation)
Unit of Measure: µg/mL
334  (63.3)
14.Secondary Outcome
Title Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Hide Description Percentage of participants with anti-drug antibodies (ADAs) to atezolizumab.
Time Frame Baseline up to approximately 20 months
Hide Outcome Measure Data
Hide Analysis Population Description
The anti-drug antibodies (ADA)-evaluable population is defined as all participants treated with atezolizumab who have at least one post-baseline ADA result.
Arm/Group Title Atezolizumab and Chemotherapy
Hide Arm/Group Description:
Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.
Overall Number of Participants Analyzed 162
Measure Type: Number
Unit of Measure: Percentage of participants
Baseline evaluable participants Number Analyzed 162 participants
2.5
Post-baseline evaluable participants Number Analyzed 157 participants
13.4
Time Frame From the first study drug to the data cutoff date 3 April 2020 (up to approximately 32 months)
Adverse Event Reporting Description Safety evaluable population is defined as all participants who received at least one dose of study medication.
 
Arm/Group Title Atezolizumab + Nab-paclitaxel + AC Placebo + Nab-paclitaxel + AC
Hide Arm/Group Description Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy. Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will be unblinded post-surgery and will continue to be followed.
All-Cause Mortality
Atezolizumab + Nab-paclitaxel + AC Placebo + Nab-paclitaxel + AC
Affected / at Risk (%) Affected / at Risk (%)
Total   7/164 (4.27%)      9/167 (5.39%)    
Hide Serious Adverse Events
Atezolizumab + Nab-paclitaxel + AC Placebo + Nab-paclitaxel + AC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   57/164 (34.76%)      36/167 (21.56%)    
Blood and lymphatic system disorders     
ANAEMIA  1  1/164 (0.61%)  1 3/167 (1.80%)  3
FEBRILE NEUTROPENIA  1  16/164 (9.76%)  18 13/167 (7.78%)  14
NEUTROPENIA  1  1/164 (0.61%)  1 2/167 (1.20%)  2
Cardiac disorders     
CARDIAC FAILURE  1  0/164 (0.00%)  0 1/167 (0.60%)  1
Endocrine disorders     
HYPOPITUITARISM  1  1/164 (0.61%)  1 1/167 (0.60%)  1
Gastrointestinal disorders     
ABDOMINAL DISTENSION  1  1/164 (0.61%)  1 0/167 (0.00%)  0
ABDOMINAL PAIN  1  0/164 (0.00%)  0 1/167 (0.60%)  1
COLITIS  1  2/164 (1.22%)  2 0/167 (0.00%)  0
DIARRHOEA  1  2/164 (1.22%)  2 0/167 (0.00%)  0
INTESTINAL OBSTRUCTION  1  1/164 (0.61%)  1 0/167 (0.00%)  0
NAUSEA  1  1/164 (0.61%)  1 2/167 (1.20%)  2
OBSTRUCTIVE PANCREATITIS  1  1/164 (0.61%)  1 0/167 (0.00%)  0
SMALL INTESTINAL OBSTRUCTION  1  1/164 (0.61%)  1 0/167 (0.00%)  0
STOMATITIS  1  1/164 (0.61%)  1 0/167 (0.00%)  0
VOMITING  1  0/164 (0.00%)  0 1/167 (0.60%)  1
General disorders     
GENERAL PHYSICAL HEALTH DETERIORATION  1  0/164 (0.00%)  0 1/167 (0.60%)  1
IMPAIRED HEALING  1  0/164 (0.00%)  0 1/167 (0.60%)  1
MALAISE  1  0/164 (0.00%)  0 1/167 (0.60%)  2
PYREXIA  1  4/164 (2.44%)  4 0/167 (0.00%)  0
Hepatobiliary disorders     
HEPATIC FUNCTION ABNORMAL  1  3/164 (1.83%)  3 0/167 (0.00%)  0
Immune system disorders     
DRUG HYPERSENSITIVITY  1  1/164 (0.61%)  1 0/167 (0.00%)  0
Infections and infestations     
BACILLUS BACTERAEMIA  1  0/164 (0.00%)  0 1/167 (0.60%)  1
CANDIDA INFECTION  1  1/164 (0.61%)  1 0/167 (0.00%)  0
CELLULITIS  1  1/164 (0.61%)  1 0/167 (0.00%)  0
DEVICE RELATED INFECTION  1  1/164 (0.61%)  1 0/167 (0.00%)  0
DIVERTICULITIS  1  1/164 (0.61%)  1 0/167 (0.00%)  0
ENCEPHALITIS  1  1/164 (0.61%)  1 0/167 (0.00%)  0
GASTROENTERITIS  1  1/164 (0.61%)  1 0/167 (0.00%)  0
INFECTION  1  1/164 (0.61%)  1 0/167 (0.00%)  0
INFLUENZA  1  1/164 (0.61%)  1 0/167 (0.00%)  0
MASTITIS  1  0/164 (0.00%)  0 1/167 (0.60%)  1
NEUTROPENIC SEPSIS  1  1/164 (0.61%)  1 0/167 (0.00%)  0
PERIORBITAL CELLULITIS  1  1/164 (0.61%)  1 0/167 (0.00%)  0
PNEUMOCYSTIS JIROVECII PNEUMONIA  1  1/164 (0.61%)  1 0/167 (0.00%)  0
PNEUMONIA  1  6/164 (3.66%)  6 1/167 (0.60%)  1
PYELONEPHRITIS ACUTE  1  1/164 (0.61%)  1 0/167 (0.00%)  0
RESPIRATORY TRACT INFECTION  1  0/164 (0.00%)  0 1/167 (0.60%)  1
SEPSIS  1  1/164 (0.61%)  1 0/167 (0.00%)  0
STAPHYLOCOCCAL BACTERAEMIA  1  1/164 (0.61%)  1 0/167 (0.00%)  0
UPPER RESPIRATORY TRACT INFECTION  1  1/164 (0.61%)  1 0/167 (0.00%)  0
URINARY TRACT INFECTION  1  1/164 (0.61%)  4 0/167 (0.00%)  0
UROSEPSIS  1  1/164 (0.61%)  1 0/167 (0.00%)  0
Injury, poisoning and procedural complications     
FRACTURE  1  1/164 (0.61%)  1 0/167 (0.00%)  0
INFUSION RELATED REACTION  1  1/164 (0.61%)  1 1/167 (0.60%)  2
PNEUMONITIS CHEMICAL  1  0/164 (0.00%)  0 1/167 (0.60%)  1
POST PROCEDURAL HAEMATOMA  1  1/164 (0.61%)  1 0/167 (0.00%)  0
ROAD TRAFFIC ACCIDENT  1  1/164 (0.61%)  1 0/167 (0.00%)  0
WOUND DEHISCENCE  1  0/164 (0.00%)  0 1/167 (0.60%)  1
Investigations     
ALANINE AMINOTRANSFERASE INCREASED  1  1/164 (0.61%)  1 0/167 (0.00%)  0
ASPARTATE AMINOTRANSFERASE INCREASED  1  1/164 (0.61%)  1 0/167 (0.00%)  0
NEUTROPHIL COUNT DECREASED  1  1/164 (0.61%)  1 2/167 (1.20%)  2
PLATELET COUNT DECREASED  1  1/164 (0.61%)  1 0/167 (0.00%)  0
Metabolism and nutrition disorders     
DEHYDRATION  1  1/164 (0.61%)  1 2/167 (1.20%)  2
DIABETES MELLITUS  1  1/164 (0.61%)  1 0/167 (0.00%)  0
HYPONATRAEMIA  1  1/164 (0.61%)  1 0/167 (0.00%)  0
VITAMIN D DEFICIENCY  1  0/164 (0.00%)  0 1/167 (0.60%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
TUMOUR HAEMORRHAGE  1  1/164 (0.61%)  1 0/167 (0.00%)  0
Nervous system disorders     
GUILLAIN-BARRE SYNDROME  1  0/164 (0.00%)  0 1/167 (0.60%)  1
PERIPHERAL MOTOR NEUROPATHY  1  0/164 (0.00%)  0 1/167 (0.60%)  1
PERIPHERAL SENSORY NEUROPATHY  1  1/164 (0.61%)  1 2/167 (1.20%)  2
POLYNEUROPATHY  1  1/164 (0.61%)  1 0/167 (0.00%)  0
SYNCOPE  1  3/164 (1.83%)  3 0/167 (0.00%)  0
Renal and urinary disorders     
RENAL INFARCT  1  0/164 (0.00%)  0 1/167 (0.60%)  1
Respiratory, thoracic and mediastinal disorders     
DYSPNOEA  1  1/164 (0.61%)  1 2/167 (1.20%)  2
HAEMOPTYSIS  1  0/164 (0.00%)  0 1/167 (0.60%)  1
INTERSTITIAL LUNG DISEASE  1  1/164 (0.61%)  1 1/167 (0.60%)  1
PNEUMONITIS  1  1/164 (0.61%)  1 2/167 (1.20%)  2
PNEUMOTHORAX  1  1/164 (0.61%)  1 0/167 (0.00%)  0
PULMONARY EMBOLISM  1  0/164 (0.00%)  0 1/167 (0.60%)  1
RESPIRATORY FAILURE  1  1/164 (0.61%)  1 0/167 (0.00%)  0
Skin and subcutaneous tissue disorders     
DERMATITIS  1  0/164 (0.00%)  0 1/167 (0.60%)  1
DERMATOMYOSITIS  1  1/164 (0.61%)  1 0/167 (0.00%)  0
Vascular disorders     
EMBOLISM  1  0/164 (0.00%)  0 1/167 (0.60%)  1
THROMBOSIS  1  0/164 (0.00%)  0 1/167 (0.60%)  1
1
Term from vocabulary, MedDRA version 23.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Atezolizumab + Nab-paclitaxel + AC Placebo + Nab-paclitaxel + AC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   161/164 (98.17%)      167/167 (100.00%)    
Blood and lymphatic system disorders     
ANAEMIA  1  64/164 (39.02%)  87 63/167 (37.72%)  78
LEUKOPENIA  1  22/164 (13.41%)  42 17/167 (10.18%)  28
NEUTROPENIA  1  64/164 (39.02%)  137 59/167 (35.33%)  122
THROMBOCYTOPENIA  1  12/164 (7.32%)  14 5/167 (2.99%)  6
Endocrine disorders     
HYPOTHYROIDISM  1  16/164 (9.76%)  16 0/167 (0.00%)  0
Eye disorders     
DRY EYE  1  13/164 (7.93%)  13 5/167 (2.99%)  5
LACRIMATION INCREASED  1  18/164 (10.98%)  21 18/167 (10.78%)  18
VISION BLURRED  1  16/164 (9.76%)  16 11/167 (6.59%)  12
Gastrointestinal disorders     
ABDOMINAL PAIN  1  22/164 (13.41%)  28 16/167 (9.58%)  21
ABDOMINAL PAIN UPPER  1  20/164 (12.20%)  22 13/167 (7.78%)  16
CONSTIPATION  1  51/164 (31.10%)  73 54/167 (32.34%)  63
DIARRHOEA  1  73/164 (44.51%)  106 74/167 (44.31%)  117
DRY MOUTH  1  10/164 (6.10%)  10 5/167 (2.99%)  6
DYSPEPSIA  1  17/164 (10.37%)  20 21/167 (12.57%)  23
NAUSEA  1  107/164 (65.24%)  214 110/167 (65.87%)  189
STOMATITIS  1  40/164 (24.39%)  48 29/167 (17.37%)  32
VOMITING  1  62/164 (37.80%)  100 51/167 (30.54%)  70
General disorders     
ASTHENIA  1  42/164 (25.61%)  66 36/167 (21.56%)  40
FATIGUE  1  62/164 (37.80%)  91 64/167 (38.32%)  84
MALAISE  1  15/164 (9.15%)  34 17/167 (10.18%)  18
MUCOSAL INFLAMMATION  1  18/164 (10.98%)  24 15/167 (8.98%)  19
OEDEMA PERIPHERAL  1  24/164 (14.63%)  30 23/167 (13.77%)  26
PAIN  1  19/164 (11.59%)  21 11/167 (6.59%)  11
PYREXIA  1  36/164 (21.95%)  55 21/167 (12.57%)  25
Infections and infestations     
NASOPHARYNGITIS  1  23/164 (14.02%)  28 13/167 (7.78%)  16
PARONYCHIA  1  18/164 (10.98%)  19 21/167 (12.57%)  21
UPPER RESPIRATORY TRACT INFECTION  1  23/164 (14.02%)  30 16/167 (9.58%)  16
URINARY TRACT INFECTION  1  18/164 (10.98%)  25 11/167 (6.59%)  11
Injury, poisoning and procedural complications     
INFUSION RELATED REACTION  1  16/164 (9.76%)  28 10/167 (5.99%)  16
PROCEDURAL PAIN  1  13/164 (7.93%)  16 2/167 (1.20%)  2
RADIATION SKIN INJURY  1  28/164 (17.07%)  28 0/167 (0.00%)  0
Investigations     
ALANINE AMINOTRANSFERASE INCREASED  1  38/164 (23.17%)  61 35/167 (20.96%)  54
ASPARTATE AMINOTRANSFERASE INCREASED  1  36/164 (21.95%)  59 27/167 (16.17%)  43
BLOOD ALKALINE PHOSPHATASE INCREASED  1  14/164 (8.54%)  19 4/167 (2.40%)  4
BLOOD LACTATE DEHYDROGENASE INCREASED  1  10/164 (6.10%)  11 7/167 (4.19%)  7
NEUTROPHIL COUNT DECREASED  1  29/164 (17.68%)  61 30/167 (17.96%)  67
WEIGHT DECREASED  1  15/164 (9.15%)  17 8/167 (4.79%)  8
WHITE BLOOD CELL COUNT DECREASED  1  14/164 (8.54%)  33 15/167 (8.98%)  35
Metabolism and nutrition disorders     
DECREASED APPETITE  1  28/164 (17.07%)  37 33/167 (19.76%)  36
HYPOKALAEMIA  1  12/164 (7.32%)  21 7/167 (4.19%)  8
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  38/164 (23.17%)  61 39/167 (23.35%)  59
BACK PAIN  1  22/164 (13.41%)  24 20/167 (11.98%)  24
BONE PAIN  1  11/164 (6.71%)  12 12/167 (7.19%)  13
MUSCULOSKELETAL PAIN  1  15/164 (9.15%)  16 3/167 (1.80%)  4
MYALGIA  1  51/164 (31.10%)  84 40/167 (23.95%)  49
PAIN IN EXTREMITY  1  27/164 (16.46%)  33 19/167 (11.38%)  25
Nervous system disorders     
DIZZINESS  1  18/164 (10.98%)  31 15/167 (8.98%)  16
DYSGEUSIA  1  16/164 (9.76%)  20 25/167 (14.97%)  27
HEADACHE  1  50/164 (30.49%)  76 35/167 (20.96%)  45
NEUROPATHY PERIPHERAL  1  39/164 (23.78%)  47 34/167 (20.36%)  42
PARAESTHESIA  1  12/164 (7.32%)  13 19/167 (11.38%)  22
PERIPHERAL SENSORY NEUROPATHY  1  57/164 (34.76%)  64 43/167 (25.75%)  46
POLYNEUROPATHY  1  9/164 (5.49%)  9 14/167 (8.38%)  15
TASTE DISORDER  1  10/164 (6.10%)  11 13/167 (7.78%)  13
Psychiatric disorders     
ANXIETY  1  11/164 (6.71%)  11 11/167 (6.59%)  11
DEPRESSION  1  10/164 (6.10%)  10 6/167 (3.59%)  6
INSOMNIA  1  46/164 (28.05%)  58 30/167 (17.96%)  32
Reproductive system and breast disorders     
BREAST PAIN  1  14/164 (8.54%)  16 14/167 (8.38%)  14
Respiratory, thoracic and mediastinal disorders     
COUGH  1  40/164 (24.39%)  51 32/167 (19.16%)  39
DYSPNOEA  1  22/164 (13.41%)  25 20/167 (11.98%)  22
EPISTAXIS  1  25/164 (15.24%)  26 24/167 (14.37%)  26
OROPHARYNGEAL PAIN  1  19/164 (11.59%)  20 18/167 (10.78%)  19
RHINORRHOEA  1  12/164 (7.32%)  14 0/167 (0.00%)  0
Skin and subcutaneous tissue disorders     
ALOPECIA  1  124/164 (75.61%)  126 129/167 (77.25%)  132
DERMATITIS ACNEIFORM  1  6/164 (3.66%)  8 10/167 (5.99%)  10
DRY SKIN  1  18/164 (10.98%)  20 13/167 (7.78%)  13
ERYTHEMA  1  14/164 (8.54%)  16 5/167 (2.99%)  5
NAIL DISCOLOURATION  1  24/164 (14.63%)  24 29/167 (17.37%)  29
NAIL DISORDER  1  21/164 (12.80%)  22 10/167 (5.99%)  10
PRURITUS  1  33/164 (20.12%)  45 24/167 (14.37%)  30
RASH  1  51/164 (31.10%)  65 42/167 (25.15%)  53
RASH MACULO-PAPULAR  1  12/164 (7.32%)  12 12/167 (7.19%)  14
Vascular disorders     
HOT FLUSH  1  28/164 (17.07%)  31 17/167 (10.18%)  20
HYPERTENSION  1  14/164 (8.54%)  26 17/167 (10.18%)  29
1
Term from vocabulary, MedDRA version 23.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03197935    
Other Study ID Numbers: WO39392
2016-004734-22 ( EudraCT Number )
First Submitted: June 21, 2017
First Posted: June 23, 2017
Results First Submitted: March 29, 2021
Results First Posted: June 2, 2021
Last Update Posted: December 9, 2021