Trial Outcomes & Findings for 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 (NCT NCT03197935)

NCT ID: NCT03197935

Last Updated: 2023-10-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

333 participants

Primary outcome timeframe

After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020

Results posted on

2023-10-26

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo and Chemotherapy 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.	Atezolizumab and Chemotherapy 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 Study STARTED	168	165
Overall Study COMPLETED	121	136
Overall Study NOT COMPLETED	47	29

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo and Chemotherapy 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.	Atezolizumab and Chemotherapy 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 Study Death due to any cause	26	15
Overall Study Lost to Follow-up	3	5
Overall Study Physician Decision	2	1
Overall Study Withdrawal by Subject	16	8

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo and Chemotherapy n=168 Participants 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.	Atezolizumab and Chemotherapy n=165 Participants 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 n=333 Participants Total of all reporting groups
Age, Continuous	50.3 Years STANDARD_DEVIATION 13.2 • n=5 Participants	50.1 Years STANDARD_DEVIATION 11.6 • n=7 Participants	50.2 Years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	168 Participants n=5 Participants	165 Participants n=7 Participants	333 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	47 Participants n=5 Participants	45 Participants n=7 Participants	92 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	114 Participants n=5 Participants	114 Participants n=7 Participants	228 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	41 Participants n=5 Participants	47 Participants n=7 Participants	88 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	9 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) White	108 Participants n=5 Participants	102 Participants n=7 Participants	210 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020

Population: ITT population (full population) is defined as all randomized participants.

Outcome measures

Outcome measures
Measure	Placebo and Chemotherapy n=168 Participants 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.	Atezolizumab and Chemotherapy n=165 Participants 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.
Number of Participants With Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population	69 Number of Participants	95 Number of Participants

PRIMARY outcome

Timeframe: After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo and Chemotherapy n=75 Participants 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.	Atezolizumab and Chemotherapy n=77 Participants 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.
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	37 Number of Participants	53 Number of Participants

SECONDARY outcome

Timeframe: From randomization and up to study final analysis data cut off on 28 September 2022.

Population: ITT population (full population) is defined as all randomized participants.

Event-free survival (EFS) defined as the time from randomization to the first documented occurrence of disease recurrence, disease progression, or death from any cause in all participants. Recurrent disease includes local, regional, or distant recurrence and contralateral breast cancer. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or recurrent disease.

Outcome measures

Outcome measures
Measure	Placebo and Chemotherapy n=168 Participants 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.	Atezolizumab and Chemotherapy n=165 Participants 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.
Event-Free Survival (EFS) in All Participants	NA Months Not estimable due low number of events.	NA Months Not estimable due low number of events.

SECONDARY outcome

Timeframe: From randomization and up to study final analysis data cut off on 28 September 2022.

Population: 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.

Event-free survival (EFS) defined as the time from randomization to the first documented occurrence of disease recurrence, disease progression, or death from any cause in the subpopulation with PD-L1-positive tumor status. Recurrent disease includes local, regional, or distant recurrence and contralateral breast cancer. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or recurrent disease.

Outcome measures

Outcome measures
Measure	Placebo and Chemotherapy n=75 Participants 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.	Atezolizumab and Chemotherapy n=77 Participants 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.
Event-Free Survival (EFS) in Subpopulation With PD-L1-Postive Tumor Status	NA Months Not estimable due low number of events.	NA Months Not estimable due low number of events.

SECONDARY outcome

Timeframe: From surgery and up to study final analysis data cut off on 28 September 2022.

Population: ITT population (full population) is defined as all randomized participants. Participants who do not undergo surgery at the end of neoadjuvant treatment are excluded from the analysis of DFS.

Disease-free survival (DFS) defined as the time from surgery to the first documented disease recurrence or death from any cause, whichever occurs first. DFS is analyzed with the use of the same methodology as specified for EFS for all participants.

Outcome measures

Outcome measures
Measure	Placebo and Chemotherapy n=153 Participants 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.	Atezolizumab and Chemotherapy n=155 Participants 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.
Disease-Free Survival (DFS) in All Participants Who Undergo Surgery	NA Months Not estimable due low number of events.	NA Months Not estimable due low number of events.

SECONDARY outcome

Timeframe: From surgery and up to study final analysis data cut off on 28 September 2022.

Population: 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. Participants who do not undergo surgery at the end of neoadjuvant treatment are excluded from the analysis of DFS in the Subpopulation of Participants with PD-L1-Positive Tumor Status.

Outcome measures

Outcome measures
Measure	Placebo and Chemotherapy n=67 Participants 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.	Atezolizumab and Chemotherapy n=73 Participants 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.
Disease-Free Survival (DFS) in Subpopulation of Participants With PD-L1-Positive Tumor Status Who Undergo Surgery	NA Months Not estimable due low number of events.	NA Months Not estimable due low number of events.

SECONDARY outcome

Timeframe: From randomization and up to study final analysis data cut off on 28 September 2022.

Population: ITT population (full population) is defined as all randomized participants.

Overall survival (OS) defined as the time from randomization to the date of death from any cause in all participants.

Outcome measures

Outcome measures
Measure	Placebo and Chemotherapy n=168 Participants 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.	Atezolizumab and Chemotherapy n=165 Participants 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 Survival (OS) in All Participants	NA Months Not estimable due low number of events.	NA Months Not estimable due low number of events.

SECONDARY outcome

Timeframe: From randomization and up to study final analysis data cut off on 28 September 2022.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo and Chemotherapy n=75 Participants 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.	Atezolizumab and Chemotherapy n=77 Participants 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 Survival (OS) in Subpopulation With PD-L1-Positive Tumor Status	NA Months Not estimable due low number of events.	NA Months Not estimable due low number of events.

SECONDARY outcome

Timeframe: From randomization and up to study final analysis data cut off on 28 September 2022.

Population: All randomized participants with non-missing baseline assessment and at least one non-missing post-baseline assessment.

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 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).

Outcome measures

Outcome measures
Measure	Placebo and Chemotherapy n=167 Participants 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.	Atezolizumab and Chemotherapy n=161 Participants 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.
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Physical Functioning Cycle 11 Day 1	85.48 Score on a 0-100 scale Interval 83.18 to 87.77	84.24 Score on a 0-100 scale Interval 81.33 to 87.15
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 GHS/QoL Survival Follow-Up Month 36	78.63 Score on a 0-100 scale Interval 74.53 to 82.73	76.93 Score on a 0-100 scale Interval 71.85 to 82.01
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 GHS/QoL Survival Follow-Up Month 48	58.33 Score on a 0-100 scale Interval -259.32 to 375.99	63.10 Score on a 0-100 scale Interval 47.77 to 78.42
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Physical Functioning Baseline	90.03 Score on a 0-100 scale Interval 87.82 to 92.24	90.85 Score on a 0-100 scale Interval 88.53 to 93.17
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Physical Functioning Cycle 2 Day 1	83.50 Score on a 0-100 scale Interval 80.79 to 86.21	84.93 Score on a 0-100 scale Interval 82.55 to 87.31
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Physical Functioning Cycle 3 Day 1	78.33 Score on a 0-100 scale Interval 75.19 to 81.48	77.29 Score on a 0-100 scale Interval 74.04 to 80.54
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Physical Functioning Cycle 4 Day 1	70.42 Score on a 0-100 scale Interval 67.06 to 73.77	69.02 Score on a 0-100 scale Interval 65.52 to 72.51
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Physical Functioning Cycle 5 Day 1	67.91 Score on a 0-100 scale Interval 64.18 to 71.65	64.27 Score on a 0-100 scale Interval 60.4 to 68.13
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Physical Functioning Cycle 6 Day 1	79.49 Score on a 0-100 scale Interval 76.38 to 82.6	78.01 Score on a 0-100 scale Interval 74.81 to 81.2
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Physical Functioning Cycle 7 Day 1	82.73 Score on a 0-100 scale Interval 79.76 to 85.71	80.78 Score on a 0-100 scale Interval 77.96 to 83.6
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Physical Functioning Cycle 8 Day 1	85.15 Score on a 0-100 scale Interval 82.75 to 87.56	81.75 Score on a 0-100 scale Interval 78.59 to 84.9
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Physical Functioning Cycle 9 Day 1	84.19 Score on a 0-100 scale Interval 81.57 to 86.81	83.99 Score on a 0-100 scale Interval 81.36 to 86.62
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Physical Functioning Cycle 10 Day 1	84.78 Score on a 0-100 scale Interval 82.16 to 87.4	83.88 Score on a 0-100 scale Interval 81.21 to 86.55
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 GHS/QoL Cycle 8 Day 1	77.17 Score on a 0-100 scale Interval 74.35 to 79.99	72.06 Score on a 0-100 scale Interval 69.01 to 75.11
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 GHS/QoL Cycle 9 Day 1	75.62 Score on a 0-100 scale Interval 72.54 to 78.69	72.18 Score on a 0-100 scale Interval 69.18 to 75.17
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 GHS/QoL Cycle 10 Day 1	75.22 Score on a 0-100 scale Interval 72.22 to 78.22	70.56 Score on a 0-100 scale Interval 67.09 to 74.03
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 GHS/QoL Cycle 11 Day 1	75.98 Score on a 0-100 scale Interval 73.17 to 78.79	71.93 Score on a 0-100 scale Interval 68.53 to 75.32
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 GHS/QoL Cycle 12 Day 1	75.84 Score on a 0-100 scale Interval 72.93 to 78.75	72.40 Score on a 0-100 scale Interval 69.27 to 75.54
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 GHS/QoL Cycle 13 Day 1	74.72 Score on a 0-100 scale Interval 71.35 to 78.08	72.87 Score on a 0-100 scale Interval 69.67 to 76.06
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 GHS/QoL Cycle 14 Day 1	74.79 Score on a 0-100 scale Interval 71.61 to 77.97	71.19 Score on a 0-100 scale Interval 67.65 to 74.43
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 GHS/QoL Cycle 15 Day 1	75.00 Score on a 0-100 scale Interval 71.85 to 78.15	74.07 Score on a 0-100 scale Interval 71.08 to 77.06
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 GHS/QoL Cycle 16 Day 1	77.70 Score on a 0-100 scale Interval 74.7 to 80.71	74.93 Score on a 0-100 scale Interval 71.69 to 78.16
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 GHS/QoL Study Drug Completion/ Early Discontinuation	75.38 Score on a 0-100 scale Interval 72.18 to 78.59	72.51 Score on a 0-100 scale Interval 68.96 to 76.05
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 GHS/QoL Survival Follow-Up Month 3	76.97 Score on a 0-100 scale Interval 73.87 to 80.07	72.65 Score on a 0-100 scale Interval 69.33 to 75.98
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 GHS/QoL Survival Follow-Up Month 6	74.93 Score on a 0-100 scale Interval 71.28 to 78.59	75.61 Score on a 0-100 scale Interval 72.09 to 79.14
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 GHS/QoL Survival Follow-Up Month 9	75.00 Score on a 0-100 scale Interval 71.32 to 76.68	75.19 Score on a 0-100 scale Interval 71.78 to 78.6
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 GHS/QoL Survival Follow-Up Month 12	75.15 Score on a 0-100 scale Interval 71.66 to 78.64	74.87 Score on a 0-100 scale Interval 71.13 to 78.6
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 GHS/QoL Survival Follow-Up Month 18	76.39 Score on a 0-100 scale Interval 72.29 to 80.48	75.60 Score on a 0-100 scale Interval 72.01 to 79.18
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 GHS/QoL Survival Follow-Up Month 24	78.31 Score on a 0-100 scale Interval 74.89 to 81.73	74.46 Score on a 0-100 scale Interval 70.55 to 78.37
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 GHS/QoL Survival Follow-Up Month 30	78.33 Score on a 0-100 scale Interval 74.08 to 82.59	73.50 Score on a 0-100 scale Interval 68.56 to 78.43
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Physical Functioning Cycle 12 Day 1	86.97 Score on a 0-100 scale Interval 84.66 to 89.29	83.44 Score on a 0-100 scale Interval 80.55 to 86.34
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Physical Functioning Cycle 16 Day 1	87.19 Score on a 0-100 scale Interval 84.34 to 90.04	84.33 Score on a 0-100 scale Interval 81.37 to 87.29
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Physical Functioning Drug Completion/Early Discontinuation	84.21 Score on a 0-100 scale Interval 81.31 to 87.1	82.34 Score on a 0-100 scale Interval 79.24 to 85.43
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Physical Functioning Survival Follow-Up Month 3	85.29 Score on a 0-100 scale Interval 82.65 to 87.93	82.35 Score on a 0-100 scale Interval 79.29 to 85.41
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Physical Functioning Survival Follow-Up Month 12	85.05 Score on a 0-100 scale Interval 81.79 to 88.3	83.17 Score on a 0-100 scale Interval 79.67 to 86.68
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Physical Functioning Cycle 13 Day 1	86.16 Score on a 0-100 scale Interval 83.4 to 88.93	83.36 Score on a 0-100 scale Interval 80.27 to 86.45
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Physical Functioning Cycle 14 Day 1	86.22 Score on a 0-100 scale Interval 83.56 to 88.88	84.96 Score on a 0-100 scale Interval 82.18 to 87.73
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Physical Functioning Cycle 15 Day 1	84.69 Score on a 0-100 scale Interval 81.67 to 87.71	84.28 Score on a 0-100 scale Interval 81.23 to 87.34
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Physical Functioning Survival Follow-Up Month 18	85.23 Score on a 0-100 scale Interval 81.63 to 88.82	84.29 Score on a 0-100 scale Interval 80.85 to 87.72
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Physical Functioning Survival Follow-Up Month 24	85.69 Score on a 0-100 scale Interval 82.05 to 89.33	85.43 Score on a 0-100 scale Interval 81.67 to 89.2
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Physical Functioning Survival Follow-Up Month 30	87.08 Score on a 0-100 scale Interval 83.41 to 90.75	84.54 Score on a 0-100 scale Interval 80.35 to 88.73
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Physical Functioning Survival Follow-Up Month 36	86.24 Score on a 0-100 scale Interval 81.63 to 90.84	85.80 Score on a 0-100 scale Interval 81.87 to 89.73
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Role Functioning Cycle 11 Day 1	79.97 Score on a 0-100 scale Interval 76.41 to 83.53	75.68 Score on a 0-100 scale Interval 71.44 to 79.93
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Role Functioning Cycle 12 Day 1	81.79 Score on a 0-100 scale Interval 78.04 to 85.55	75.14 Score on a 0-100 scale Interval 70.52 to 79.75
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Role Functioning Cycle 13 Day 1	81.79 Score on a 0-100 scale Interval 78.16 to 85.42	74.38 Score on a 0-100 scale Interval 69.6 to 79.16
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Physical Functioning Survival Follow-Up Month 48	90.00 Score on a 0-100 scale Interval -37.06 to 217.06	88.57 Score on a 0-100 scale Interval 75.88 to 101.26
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Role Functioning Baseline	88.86 Score on a 0-100 scale Interval 85.67 to 92.04	89.44 Score on a 0-100 scale Interval 86.1 to 92.78
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Role Functioning Cycle 2 Day 1	80.39 Score on a 0-100 scale Interval 76.77 to 84.0	77.18 Score on a 0-100 scale Interval 73.47 to 80.88
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Physical Functioning Survival Follow-Up Month 6	84.96 Score on a 0-100 scale Interval 82.15 to 87.77	84.17 Score on a 0-100 scale Interval 81.11 to 87.22
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Physical Functioning Survival Follow-Up Month 9	85.11 Score on a 0-100 scale Interval 82.46 to 87.77	83.48 Score on a 0-100 scale Interval 80.01 to 86.96
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Role Functioning Cycle 14 Day 1	80.81 Score on a 0-100 scale Interval 76.61 to 85.01	75.50 Score on a 0-100 scale Interval 70.6 to 80.4
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Role Functioning Cycle 15 Day 1	79.02 Score on a 0-100 scale Interval 75.14 to 82.9	77.59 Score on a 0-100 scale Interval 73.05 to 82.13
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Role Functioning Cycle 3 Day 1	70.39 Score on a 0-100 scale Interval 65.96 to 74.83	69.48 Score on a 0-100 scale Interval 65.29 to 73.67
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Role Functioning Cycle 4 Day 1	61.11 Score on a 0-100 scale Interval 56.7 to 65.53	56.60 Score on a 0-100 scale Interval 51.56 to 61.64
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Role Functioning Cycle 16 Day 1	83.03 Score on a 0-100 scale Interval 78.87 to 87.2	78.65 Score on a 0-100 scale Interval 74.05 to 83.26
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Role Functioning Survival Follow-Up Month 3	81.93 Score on a 0-100 scale Interval 78.24 to 85.63	75.47 Score on a 0-100 scale Interval 70.97 to 79.97
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Role Functioning Cycle 5 Day 1	56.06 Score on a 0-100 scale Interval 51.06 to 61.04	51.08 Score on a 0-100 scale Interval 46.15 to 56.0
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Role Functioning Cycle 6 Day 1	66.17 Score on a 0-100 scale Interval 61.45 to 70.89	62.88 Score on a 0-100 scale Interval 57.7 to 68.06
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Role Functioning Cycle 7 Day 1	73.77 Score on a 0-100 scale Interval 69.21 to 78.33	69.92 Score on a 0-100 scale Interval 65.46 to 74.39
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Role Functioning Cycle 8 Day 1	77.59 Score on a 0-100 scale Interval 73.57 to 81.62	72.95 Score on a 0-100 scale Interval 68.13 to 77.77
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Role Functioning Cycle 9 Day 1	77.13 Score on a 0-100 scale Interval 72.98 to 81.29	74.32 Score on a 0-100 scale Interval 70.21 to 78.42
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Role Functioning Cycle 10 Day 1	78.51 Score on a 0-100 scale Interval 74.5 to 82.51	75.27 Score on a 0-100 scale Interval 70.94 to 79.61
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Role Functioning Study Drug Completion/Early Discontinuation	80.00 Score on a 0-100 scale Interval 76.07 to 83.93	74.09 Score on a 0-100 scale Interval 69.37 to 78.81
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Role Functioning Survival Follow-Up Month 6	78.53 Score on a 0-100 scale Interval 74.01 to 83.06	76.10 Score on a 0-100 scale Interval 71.38 to 80.83
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 GHS/QoL Baseline	76.45 Score on a 0-100 scale Interval 73.47 to 79.42	79.24 Score on a 0-100 scale Interval 76.34 to 82.14
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 GHS/QoL Cycle 2 Day 1	71.90 Score on a 0-100 scale Interval 69.04 to 74.76	71.55 Score on a 0-100 scale Interval 68.53 to 74.57
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 GHS/QoL Cycle 3 Day 1	65.30 Score on a 0-100 scale Interval 62.25 to 68.34	62.65 Score on a 0-100 scale Interval 58.94 to 66.36
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 GHS/QoL Cycle 4 Day 1	62.36 Score on a 0-100 scale Interval 59.15 to 65.58	59.84 Score on a 0-100 scale Interval 56.62 to 63.07
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 GHS/QoL Cycle Cycle 5 Day 1	60.37 Score on a 0-100 scale Interval 56.87 to 63.87	53.60 Score on a 0-100 scale Interval 49.71 to 57.48
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 GHS/QoL Cycle 6 Day 1	74.25 Score on a 0-100 scale Interval 70.86 to 77.65	70.14 Score on a 0-100 scale Interval 66.97 to 73.31
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 GHS/QoL Cycle 7 Day 1	76.50 Score on a 0-100 scale Interval 73.39 to 79.62	73.57 Score on a 0-100 scale Interval 70.92 to 76.22
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Role Functioning Survival Follow-Up Month 9	81.61 Score on a 0-100 scale Interval 77.9 to 85.32	76.39 Score on a 0-100 scale Interval 71.36 to 81.42
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Role Functioning Survival Follow-Up Month 12	81.68 Score on a 0-100 scale Interval 77.46 to 85.91	76.98 Score on a 0-100 scale Interval 71.47 to 82.5
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Role Functioning Survival Follow-Up Month 18	81.86 Score on a 0-100 scale Interval 76.88 to 86.85	77.98 Score on a 0-100 scale Interval 72.77 to 83.18
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Role Functioning Survival Follow-Up Month 24	79.47 Score on a 0-100 scale Interval 73.62 to 85.32	80.09 Score on a 0-100 scale Interval 75.03 to 85.15
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Role Functioning Survival Follow-Up Month 30	81.54 Score on a 0-100 scale Interval 75.51 to 87.56	78.24 Score on a 0-100 scale Interval 71.2 to 85.28
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Role Functioning Survival Follow-Up Month 36	85.48 Score on a 0-100 scale Interval 79.88 to 91.09	81.64 Score on a 0-100 scale Interval 75.23 to 88.05
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 Role Functioning Survival Follow-Up Month 48	83.33 Score on a 0-100 scale Interval -128.44 to 295.1	76.19 Score on a 0-100 scale Interval -228.44 to 195.1

SECONDARY outcome

Timeframe: From randomization and up to study final analysis data cut off on 28 September 2022.

Population: All randomized participants with non-missing baseline assessment and at least one non-missing post-baseline assessment.

Mean change from baseline 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).

Outcome measures

Outcome measures
Measure	Placebo and Chemotherapy n=167 Participants 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.	Atezolizumab and Chemotherapy n=161 Participants 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.
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 GHS/QoL Cycle 2 Day 1	-4.62 Score on a 0-100 scale. Interval -7.89 to -1.36	-7.91 Score on a 0-100 scale. Interval -11.09 to -4.72
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 GHS/QoL Cycle 3 Day 1	-12.72 Score on a 0-100 scale. Interval -16.34 to -9.1	-17.07 Score on a 0-100 scale. Interval -21.15 to -13.0
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 GHS/QoL Cycle 4 Day 1	-14.49 Score on a 0-100 scale. Interval -18.35 to -10.62	-19.80 Score on a 0-100 scale. Interval -23.5 to -16.09
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 GHS/QoL Cycle Cycle 5 Day 1	-17.06 Score on a 0-100 scale. Interval -21.18 to -12.94	-26.02 Score on a 0-100 scale. Interval -30.34 to -21.7
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 GHS/QoL Cycle 6 Day 1	-2.49 Score on a 0-100 scale. Interval -6.7 to 1.72	-8.78 Score on a 0-100 scale. Interval -12.71 to -4.84
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 GHS/QoL Cycle 7 Day 1	-0.61 Score on a 0-100 scale. Interval -4.64 to 3.41	-5.40 Score on a 0-100 scale. Interval -9.15 to -1.66
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 GHS/QoL Cycle 8 Day 1	0.77 Score on a 0-100 scale. Interval -3.3 to 4.84	-6.69 Score on a 0-100 scale. Interval -10.49 to -2.9
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 GHS/QoL Cycle 9 Day 1	-0.28 Score on a 0-100 scale. Interval -4.1 to 3.55	-6.13 Score on a 0-100 scale. Interval -9.94 to -2.32
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 GHS/QoL Cycle 10 Day 1	-1.17 Score on a 0-100 scale. Interval -5.02 to 2.68	-8.40 Score on a 0-100 scale. Interval -12.5 to -4.3
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 GHS/QoL Cycle 11 Day 1	0.35 Score on a 0-100 scale. Interval -3.42 to 4.13	-7.04 Score on a 0-100 scale. Interval -11.11 to -2.96
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 GHS/QoL Cycle 12 Day 1	-0.63 Score on a 0-100 scale. Interval -4.64 to 3.38	-6.56 Score on a 0-100 scale. Interval -10.48 to -2.64
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 GHS/QoL Cycle 13 Day 1	-1.26 Score on a 0-100 scale. Interval -5.19 to 2.67	-5.85 Score on a 0-100 scale. Interval -9.83 to -1.88
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 GHS/QoL Cycle 14 Day 1	-1.05 Score on a 0-100 scale. Interval -4.95 to 2.85	-7.47 Score on a 0-100 scale. Interval -11.44 to -3.5
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 GHS/QoL Cycle 15 Day 1	0.00 Score on a 0-100 scale. Interval -4.21 to 4.21	-4.67 Score on a 0-100 scale. Interval -8.71 to -0.63
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 GHS/QoL Cycle 16 Day 1	2.10 Score on a 0-100 scale. Interval -1.66 to 5.86	-3.73 Score on a 0-100 scale. Interval -7.93 to 0.48
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 GHS/QoL Study Drug Completion/ Early Discontinuation	0.06 Score on a 0-100 scale. Interval -3.99 to 4.12	-6.20 Score on a 0-100 scale. Interval -10.47 to -1.94
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 GHS/QoL Survival Follow-Up Month 3	0.64 Score on a 0-100 scale. Interval -3.54 to 4.81	-6.57 Score on a 0-100 scale. Interval -10.28 to -2.87
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 GHS/QoL Survival Follow-Up Month 6	-2.00 Score on a 0-100 scale. Interval -6.16 to 2.16	-3.37 Score on a 0-100 scale. Interval -7.24 to 0.5
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 GHS/QoL Survival Follow-Up Month 9	-0.93 Score on a 0-100 scale. Interval -5.26 to 3.39	-4.42 Score on a 0-100 scale. Interval -8.07 to -0.77
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 GHS/QoL Survival Follow-Up Month 12	-1.65 Score on a 0-100 scale. Interval -5.91 to 2.61	-4.50 Score on a 0-100 scale. Interval -8.67 to -0.32
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 GHS/QoL Survival Follow-Up Month 18	-0.98 Score on a 0-100 scale. Interval -6.1 to 4.14	-4.17 Score on a 0-100 scale. Interval -8.67 to 0.34
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 GHS/QoL Survival Follow-Up Month 24	1.31 Score on a 0-100 scale. Interval -3.5 to 6.12	-6.17 Score on a 0-100 scale. Interval -10.96 to -1.39
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 GHS/QoL Survival Follow-Up Month 30	-2.18 Score on a 0-100 scale. Interval -8.05 to 3.69	-9.14 Score on a 0-100 scale. Interval -14.26 to -4.03
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 GHS/QoL Survival Follow-Up Month 36	-1.08 Score on a 0-100 scale. Interval -6.42 to 4.27	-5.56 Score on a 0-100 scale. Interval -11.22 to 0.11
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 GHS/QoL Survival Follow-Up Month 48	-25.00 Score on a 0-100 scale. Interval -342.66 to 292.66	-21.43 Score on a 0-100 scale. Interval -37.99 to -4.86
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 Physical Functioning Cycle 2 Day 1	-6.37 Score on a 0-100 scale. Interval -8.58 to -4.16	-5.73 Score on a 0-100 scale. Interval -8.18 to -3.29
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 Physical Functioning Cycle 3 Day 1	-12.17 Score on a 0-100 scale. Interval -15.43 to -8.92	-12.90 Score on a 0-100 scale. Interval -16.62 to -9.17
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 Physical Functioning Cycle 4 Day 1	-19.48 Score on a 0-100 scale. Interval -22.51 to -16.45	-21.68 Score on a 0-100 scale. Interval -25.66 to -17.7
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 Physical Functioning Cycle 5 Day 1	-21.59 Score on a 0-100 scale. Interval -25.17 to -18.01	-26.43 Score on a 0-100 scale. Interval -30.61 to -22.25
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 Physical Functioning Cycle 6 Day 1	-10.20 Score on a 0-100 scale. Interval -13.46 to -6.94	-12.20 Score on a 0-100 scale. Interval -15.39 to -9.0
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 Physical Functioning Cycle 7 Day 1	-7.43 Score on a 0-100 scale. Interval -10.48 to -4.38	-8.96 Score on a 0-100 scale. Interval -12.22 to -5.69
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 Physical Functioning Cycle 8 Day 1	-4.80 Score on a 0-100 scale. Interval -7.52 to -2.09	-7.70 Score on a 0-100 scale. Interval -11.21 to -4.19
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 Physical Functioning Cycle 9 Day 1	-5.40 Score on a 0-100 scale. Interval -8.2 to -2.6	-5.74 Score on a 0-100 scale. Interval -9.04 to -2.44
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 Physical Functioning Cycle 10 Day 1	-4.87 Score on a 0-100 scale. Interval -7.82 to -1.92	-6.17 Score on a 0-100 scale. Interval -9.25 to -3.1
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 Physical Functioning Cycle 11 Day 1	-3.99 Score on a 0-100 scale. Interval -6.77 to -1.21	-5.73 Score on a 0-100 scale. Interval -9.09 to -2.37
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 Physical Functioning Cycle 12 Day 1	-2.59 Score on a 0-100 scale. Interval -5.39 to 0.21	-6.61 Score on a 0-100 scale. Interval -9.6 to -3.62
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 Physical Functioning Cycle 13 Day 1	-3.63 Score on a 0-100 scale. Interval -6.77 to -0.48	-6.72 Score on a 0-100 scale. Interval -10.01 to -3.43
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 Physical Functioning Cycle 14 Day 1	-3.42 Score on a 0-100 scale. Interval -6.33 to -0.51	-5.07 Score on a 0-100 scale. Interval -8.25 to -1.89
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 Physical Functioning Cycle 15 Day 1	-4.24 Score on a 0-100 scale. Interval -7.59 to -0.89	-5.89 Score on a 0-100 scale. Interval -9.22 to -2.56
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 Physical Functioning Cycle 16 Day 1	-2.42 Score on a 0-100 scale. Interval -5.7 to 0.86	-5.79 Score on a 0-100 scale. Interval -9.05 to -2.53
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 Physical Functioning Study Drug Completion/Early Discontinuation	-5.58 Score on a 0-100 scale. Interval -8.88 to -2.27	-8.66 Score on a 0-100 scale. Interval -12.12 to -5.21
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 Physical Functioning Survival Follow-Up Month 3	-4.16 Score on a 0-100 scale. Interval -6.77 to -1.55	-8.54 Score on a 0-100 scale. Interval -11.83 to -5.26
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 Physical Functioning Survival Follow-Up Month 6	-5.21 Score on a 0-100 scale. Interval -7.9 to -2.53	-6.91 Score on a 0-100 scale. Interval -10.1 to -3.72
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 Physical Functioning Survival Follow-Up Month 9	-3.97 Score on a 0-100 scale. Interval -6.65 to -1.28	-7.78 Score on a 0-100 scale. Interval -11.2 to -4.36
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 Physical Functioning Survival Follow-Up Month 12	-4.43 Score on a 0-100 scale. Interval -7.23 to -1.62	-7.46 Score on a 0-100 scale. Interval -11.07 to -3.85
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 Physical Functioning Survival Follow-Up Month 18	-4.90 Score on a 0-100 scale. Interval -8.58 to -1.22	-6.61 Score on a 0-100 scale. Interval -10.17 to -3.05
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 Physical Functioning Survival Follow-Up Month 24	-4.07 Score on a 0-100 scale. Interval -7.64 to -0.49	-6.30 Score on a 0-100 scale. Interval -9.94 to -2.65
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 Physical Functioning Survival Follow-Up Month 30	-3.36 Score on a 0-100 scale. Interval -6.9 to 0.18	-10.46 Score on a 0-100 scale. Interval -14.68 to -6.25
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 Physical Functioning Survival Follow-Up Month 36	-4.06 Score on a 0-100 scale. Interval -8.93 to 0.81	-8.70 Score on a 0-100 scale. Interval -12.47 to -4.92
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 Physical Functioning Survival Follow-Up Month 48	-3.33 Score on a 0-100 scale. Interval -45.69 to 39.02	-11.43 Score on a 0-100 scale. Interval -24.12 to 1.26
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 Role Functioning Cycle 2 Day 1	-8.08 Score on a 0-100 scale. Interval -12.05 to -4.11	-12.42 Score on a 0-100 scale. Interval -16.7 to -8.14
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 Role Functioning Cycle 3 Day 1	-19.54 Score on a 0-100 scale. Interval -24.57 to -14.5	-19.84 Score on a 0-100 scale. Interval -24.92 to -14.76
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 Role Functioning Cycle 4 Day 1	-28.29 Score on a 0-100 scale. Interval -33.49 to -23.09	-33.56 Score on a 0-100 scale. Interval -39.19 to -27.93
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 Role Functioning Cycle 5 Day 1	-32.99 Score on a 0-100 scale. Interval -38.45 to -27.53	-38.97 Score on a 0-100 scale. Interval -44.44 to -33.5
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 Role Functioning Cycle 6 Day 1	-22.39 Score on a 0-100 scale. Interval -27.55 to -17.23	-26.14 Score on a 0-100 scale. Interval -31.45 to -20.83
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 Role Functioning Cycle 7 Day 1	-14.21 Score on a 0-100 scale. Interval -19.06 to -9.35	-18.36 Score on a 0-100 scale. Interval -23.36 to -13.36
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 Role Functioning Cycle 8 Day 1	-10.50 Score on a 0-100 scale. Interval -15.16 to -5.85	-14.89 Score on a 0-100 scale. Interval -20.37 to -9.41
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 Role Functioning Cycle 9 Day 1	-10.74 Score on a 0-100 scale. Interval -15.21 to -6.28	-13.80 Score on a 0-100 scale. Interval -19.13 to -8.47
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 Role Functioning Cycle 10 Day 1	-9.36 Score on a 0-100 scale. Interval -13.94 to -4.77	-13.39 Score on a 0-100 scale. Interval -18.13 to -8.64
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 Role Functioning Cycle 11 Day 1	-8.26 Score on a 0-100 scale. Interval -12.65 to -3.88	-12.98 Score on a 0-100 scale. Interval -17.53 to -8.43
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 Role Functioning Cycle 12 Day 1	-6.86 Score on a 0-100 scale. Interval -11.4 to -2.33	-13.52 Score on a 0-100 scale. Interval -18.06 to -8.99
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 Role Functioning Cycle 13 Day 1	-6.30 Score on a 0-100 scale. Interval -10.16 to -2.44	-14.46 Score on a 0-100 scale. Interval -19.69 to -9.24
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 Role Functioning Cycle 14 Day 1	-7.28 Score on a 0-100 scale. Interval -11.77 to -2.8	-13.82 Score on a 0-100 scale. Interval -18.8 to -8.84
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 Role Functioning Cycle 15 Day 1	-8.63 Score on a 0-100 scale. Interval -13.14 to -4.12	-11.78 Score on a 0-100 scale. Interval -16.96 to -6.6
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 Role Functioning Cycle 16 Day 1	-4.65 Score on a 0-100 scale. Interval -9.7 to 0.39	-10.82 Score on a 0-100 scale. Interval -15.56 to -6.07
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 Role Functioning Study Drug Completion/Early Discontinuation	-8.46 Score on a 0-100 scale. Interval -13.54 to -3.38	-16.42 Score on a 0-100 scale. Interval -21.64 to -11.21
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 Role Functioning Survival Follow-Up Month 3	-5.98 Score on a 0-100 scale. Interval -10.57 to -1.39	-14.44 Score on a 0-100 scale. Interval -19.35 to -9.53
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 Role Functioning Survival Follow-Up Month 6	-10.67 Score on a 0-100 scale. Interval -15.66 to -5.68	-13.97 Score on a 0-100 scale. Interval -18.84 to -9.1
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 Role Functioning Survival Follow-Up Month 9	-7.61 Score on a 0-100 scale. Interval -12.23 to -3.0	-13.76 Score on a 0-100 scale. Interval -18.45 to -9.08
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 Role Functioning Survival Follow-Up Month 12	-7.66 Score on a 0-100 scale. Interval -11.9 to -3.41	-12.83 Score on a 0-100 scale. Interval -18.13 to -7.53
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 Role Functioning Survival Follow-Up Month 18	-7.03 Score on a 0-100 scale. Interval -12.54 to -1.51	-12.05 Score on a 0-100 scale. Interval -17.15 to -6.95
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 Role Functioning Survival Follow-Up Month 24	-9.96 Score on a 0-100 scale. Interval -15.85 to -4.07	-10.96 Score on a 0-100 scale. Interval -16.19 to -5.72
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 Role Functioning Survival Follow-Up Month 30	-8.72 Score on a 0-100 scale. Interval -15.45 to -1.98	-16.44 Score on a 0-100 scale. Interval -23.12 to -9.75
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 Role Functioning Survival Follow-Up Month 36	-5.65 Score on a 0-100 scale. Interval -12.45 to 1.16	-12.56 Score on a 0-100 scale. Interval -18.94 to -6.18
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 Role Functioning Survival Follow-Up Month 48	-16.67 Score on a 0-100 scale. Interval -228.44 to 195.1	-21.43 Score on a 0-100 scale. Interval -47.7 to 4.84

SECONDARY outcome

Timeframe: From randomization and up to study final analysis data cut off on 28 September 2022.

Population: Safety population is defined as all participants who received any dose of study medication.

Percentage of participants with at least one adverse event.

Outcome measures

Outcome measures
Measure	Placebo and Chemotherapy n=164 Participants 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.	Atezolizumab and Chemotherapy n=167 Participants 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.
Percentage of Participants With at Least One Adverse Events (AEs)	100 Percentage of participants	100 Percentage of participants

SECONDARY outcome

Timeframe: 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)

Population: The pharmacokinetic-evaluable population is defined as all participants who received any dose of atezolizumab and who have evaluable pharmacokinetic (PK) samples.

Minimum observed serum atezolizumab concentration.

Outcome measures

Outcome measures
Measure	Placebo and Chemotherapy n=164 Participants 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.	Atezolizumab and Chemotherapy 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.
Minimum Observed Serum Atezolizumab Concentration (Cmin) Cycle 2 Day 1	142 µg/mL Standard Deviation 54.3	—
Minimum Observed Serum Atezolizumab Concentration (Cmin) Cycle 3 Day 1	189 µg/mL Standard Deviation 64.2	—
Minimum Observed Serum Atezolizumab Concentration (Cmin) Cycle 4 Day 1	207 µg/mL Standard Deviation 77.3	—
Minimum Observed Serum Atezolizumab Concentration (Cmin) Cycle 6 Day 1	78.7 µg/mL Standard Deviation 50.3	—
Minimum Observed Serum Atezolizumab Concentration (Cmin) Cycle 8 Day 1	204 µg/mL Standard Deviation 62.7	—
Minimum Observed Serum Atezolizumab Concentration (Cmin) Cycle 12 Day 1	267 µg/mL Standard Deviation 81.1	—
Minimum Observed Serum Atezolizumab Concentration (Cmin) Cycle 16 Day 1	303 µg/mL Standard Deviation 89.1	—

SECONDARY outcome

Timeframe: Day 1 of Cycle 1 post dose (cycle length = 28 days)

Population: The pharmacokinetic-evaluable population is defined as all participants who received any dose of atezolizumab and who have evaluable pharmacokinetic (PK) samples.

Maximum observed atezolizumab concentration (Cmax).

Outcome measures

Outcome measures
Measure	Placebo and Chemotherapy n=164 Participants 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.	Atezolizumab and Chemotherapy 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.
Maximum Observed Serum Atezolizumab Concentration (Cmax)	334 µg/mL Standard Deviation 63.3	—

SECONDARY outcome

Timeframe: Baseline up to approximately 20 months

Population: The anti-drug antibodies (ADA)-evaluable population is defined as all participants treated with atezolizumab who have at least one post-baseline ADA result.

Percentage of participants with anti-drug antibodies (ADAs) to atezolizumab.

Outcome measures

Outcome measures
Measure	Placebo and Chemotherapy n=162 Participants 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.	Atezolizumab and Chemotherapy 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.
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab Baseline evaluable participants	2.5 Percentage of participants	—
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab Post-baseline evaluable participants	13.4 Percentage of participants	—

Adverse Events

Placebo and Chemotherapy

Serious events: 36 serious events

Other events: 167 other events

Deaths: 28 deaths

Atezolizumab and Chemotherapy

Serious events: 59 serious events

Other events: 162 other events

Deaths: 16 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER