A Study to Investigate Atezolizumab and Chemotherapy Comp... | NCT03197935

ID	Type	Description	Link
2016-004734-22	EudraCT Number

Label	Type	Description	Intervention Names
Atezolizumab and Chemotherapy	Experimental	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.	Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody Drug: Nab-paclitaxel Drug: Doxorubicin Drug: Cyclophosphamide Drug: Filgrastim Drug: Pegfilgrastim
Placebo and Chemotherapy	Placebo Comparator	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.	Drug: Placebo Drug: Nab-paclitaxel Drug: Doxorubicin Drug: Cyclophosphamide Drug: Filgrastim Drug: Pegfilgrastim

Name	Type	Description	Arm Group Labels	Other Names
Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody	Drug	Atezolizumab was administered as per schedule described in respective arm.	Atezolizumab and Chemotherapy

Measure	Description	Time Frame
Number of Participants With Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population	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.	After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020
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	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.	After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020

Measure	Description	Time Frame
Event-Free Survival (EFS) in All 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.

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Histologically documented TNBC (negative human epidermal growth factor receptor 2 [HER2], estrogen receptor [ER], and progesterone receptor [PgR] status)
Confirmed tumor programmed death-ligand 1 (PD-L1) evaluation as documented through central testing of a representative tumor tissue specimen
Primary breast tumor size of greater than (>) 2 centimeters (cm) by at least one radiographic or clinical measurement
Stage at presentation: cT2-cT4, cN0-cN3, cM0
Participant agreement to undergo appropriate surgical management including axillary lymph node surgery and partial or total mastectomy after completion of neoadjuvant treatment
Baseline left ventricular ejection fraction (LVEF) greater than or equal to (>=) 53 percent (%) measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans
Adequate hematologic and end-organ function
Representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in paraffin blocks (preferred) or at least 20 unstained slides, with an associated pathology report documenting ER, PgR, and HER2 negativity
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm
Women who are not postmenopausal or have undergone a sterilization procedure must have a negative serum pregnancy test result within 14 days prior to initiation of study drug

Exclusion criteria:

Prior history of invasive breast cancer
Stage 4 (metastatic) breast cancer
Prior systemic therapy for treatment and prevention of breast cancer
Previous therapy with anthracyclines or taxanes for any malignancy
History of ductal carcinoma in situ (DCIS), except for participants treated exclusively with mastectomy >5 years prior to diagnosis of current breast cancer
History of pleomorphic lobular carcinoma in situ (LCIS), except for participants surgically managed >5 years prior to diagnosis of current breast cancer
Bilateral breast cancer
Undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes
Axillary lymph node dissection prior to initiation of neoadjuvant therapy
History of other malignancy within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death
Cardiopulmonary dysfunction
History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells
Known allergy or hypersensitivity to the components of the formulations of atezolizumab, nab-paclitaxel, cyclophosphamide, or doxorubicin, filgrastim or pegfilgrastim
Active or history of autoimmune disease or immune deficiency diseases except history of autoimmune-related hypothyroidism, controlled Type 1 diabetes mellitus, and dermatologic manifestations of eczema, psoriasis, lichen simplex chronicus, or vitiligo (e.g., participants with psoriatic arthritis are excluded)
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
Positive human immunodeficiency virus (HIV) test at screening
Active hepatitis B and hepatitis C virus infection
Active tuberculosis
Severe infections within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment, except prophylactic antibiotics
Major surgical procedure within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study
Prior allogeneic stem cell or solid organ transplantation
Administration of a live attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation of need for such a vaccine during the study
Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications
Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint-blockade therapies, including anti-cluster of differentiation 40 (anti-CD40), anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies
Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to initiation of study treatment
Treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressive medications during the study
History of cerebrovascular accident within 12 months prior to randomization
Pregnant or lactating, or intending to become pregnant during the study

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University Medical Center		Palo Alto	California	94304	United States
Norwalk Hospital

PubMed Identifier	Type	Citation	Retractions
40467898	Derived	Mittendorf EA, Assaf ZJ, Harbeck N, Zhang H, Saji S, Jung KH, Hegg R, Koehler A, Sohn J, Iwata H, Telli ML, Ferrario C, Punie K, Qamra A, Dieterich M, Xu Y, Liste-Hermoso M, Shearer-Kang E, Molinero L, Chui SY, Barrios CH. Peri-operative atezolizumab in early-stage triple-negative breast cancer: final results and ctDNA analyses from the randomized phase 3 IMpassion031 trial. Nat Med. 2025 Jul;31(7):2397-2404. doi: 10.1038/s41591-025-03725-4. Epub 2025 Jun 4.
32966830

ID	Title	Description
FG000	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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 24, 2022	Oct 23, 2023

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population

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.

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

Posted

Number

Number of Participants

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

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000168 OG001165

Title

Denominators

Categories

Title	Measurements
	OG00069 OG00195

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Stratified analysis. Strata are: tumor PD-L1 status (IC0 vs. IC1/2/3) and clinical stage at presentation (Stage II vs. III).	Cochran-Mantel-Haenszel		0.0044	(one-sided)	Absolute difference in pCR rate	16.50			2-Sided	95	5.91	27.10					Superiority

Primary

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

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.

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.

Posted

Number

Number of Participants

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

ID	Title	Description
OG000	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.
OG001	Atezolizumab and Chemotherapy

Secondary

Event-Free Survival (EFS) in All 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.

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

Posted

Median

95% Confidence Interval

Months

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Event-Free Survival (EFS) in Subpopulation With PD-L1-Postive Tumor Status

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.

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.

Posted

Number

95% Confidence Interval

Months

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Disease-Free Survival (DFS) in All Participants Who Undergo Surgery

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.

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.

Posted

Median

95% Confidence Interval

Months

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Disease-Free Survival (DFS) in Subpopulation of Participants With PD-L1-Positive Tumor Status Who Undergo Surgery

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.

Posted

Median

95% Confidence Interval

Months

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Overall Survival (OS) in All Participants

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

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

Posted

Median

95% Confidence Interval

Months

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Overall Survival (OS) in Subpopulation With PD-L1-Positive Tumor Status

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.

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.

Posted

Median

95% Confidence Interval

Months

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30

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).

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

Posted

Mean

95% Confidence Interval

Score on a 0-100 scale

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

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

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).

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

Posted

Mean

95% Confidence Interval

Score on a 0-100 scale.

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Percentage of Participants With at Least One Adverse Events (AEs)

Percentage of participants with at least one adverse event.

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

Posted

Number

Percentage of participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Minimum Observed Serum Atezolizumab Concentration (Cmin)

Minimum observed serum atezolizumab concentration.

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

Posted

Mean

Standard Deviation

µg/mL

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)

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Maximum Observed Serum Atezolizumab Concentration (Cmax)

Maximum observed atezolizumab concentration (Cmax).

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

Posted

Mean

Standard Deviation

µg/mL

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

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab

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

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

Posted

Number

Percentage of participants

Baseline up to approximately 20 months

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA version 25.1	Systematic Assessment	EG0003 events3 affected167 at risk EG0011 events1 affected164 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA version 25.1	Systematic Assessment	EG00014 events13 affected167 at risk EG00118 events16 affected164 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA version 25.1	Systematic Assessment	EG0002 events2 affected167 at risk EG0011 events1 affected164 at risk
Cardiac failure	Cardiac disorders	MedDRA version 25.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0010 events0 affected164 at risk
Hypopituitarism	Endocrine disorders	MedDRA version 25.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0011 events1 affected164 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA version 25.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0010 events0 affected164 at risk
Colitis	Gastrointestinal disorders	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0012 events2 affected164 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0012 events2 affected164 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Nausea	Gastrointestinal disorders	MedDRA version 25.1	Systematic Assessment	EG0002 events2 affected167 at risk EG0011 events1 affected164 at risk
Obstructive pancreatitis	Gastrointestinal disorders	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Stomatitis	Gastrointestinal disorders	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Vomiting	Gastrointestinal disorders	MedDRA version 25.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0010 events0 affected164 at risk
Asthenia	General disorders	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
General physical health deterioration	General disorders	MedDRA version 25.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0010 events0 affected164 at risk
Impaired healing	General disorders	MedDRA version 25.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0010 events0 affected164 at risk
Malaise	General disorders	MedDRA version 25.1	Systematic Assessment	EG0002 events1 affected167 at risk EG0010 events0 affected164 at risk
Pyrexia	General disorders	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0014 events4 affected164 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0013 events3 affected164 at risk
Drug hypersensitivity	Immune system disorders	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Abdominal infection	Infections and infestations	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Bacillus bacteraemia	Infections and infestations	MedDRA version 25.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0010 events0 affected164 at risk
Candida infection	Infections and infestations	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Cellulitis	Infections and infestations	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Diverticulitis	Infections and infestations	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Encephalitis	Infections and infestations	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Gastroenteritis	Infections and infestations	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Infection	Infections and infestations	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Influenza	Infections and infestations	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Mastitis	Infections and infestations	MedDRA version 25.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0010 events0 affected164 at risk
Neutropenic sepsis	Infections and infestations	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Periorbital cellulitis	Infections and infestations	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Pneumonia	Infections and infestations	MedDRA version 25.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0016 events6 affected164 at risk
Pyelonephritis acute	Infections and infestations	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Respiratory tract infection	Infections and infestations	MedDRA version 25.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0010 events0 affected164 at risk
Sepsis	Infections and infestations	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Urinary tract infection	Infections and infestations	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0014 events1 affected164 at risk
Urosepsis	Infections and infestations	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Vascular device infection	Infections and infestations	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA version 25.1	Systematic Assessment	EG0002 events1 affected167 at risk EG0011 events1 affected164 at risk
Pneumonitis chemical	Injury, poisoning and procedural complications	MedDRA version 25.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0010 events0 affected164 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA version 25.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0010 events0 affected164 at risk
Alanine aminotransferase increased	Investigations	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Aspartate aminotransferase increased	Investigations	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Neutrophil count decreased	Investigations	MedDRA version 25.1	Systematic Assessment	EG0002 events2 affected167 at risk EG0011 events1 affected164 at risk
Platelet count decreased	Investigations	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA version 25.1	Systematic Assessment	EG0002 events2 affected167 at risk EG0011 events1 affected164 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA version 25.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0010 events0 affected164 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA version 25.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0010 events0 affected164 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA version 25.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0010 events0 affected164 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA version 25.1	Systematic Assessment	EG0002 events2 affected167 at risk EG0011 events1 affected164 at risk
Polyneuropathy	Nervous system disorders	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Syncope	Nervous system disorders	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0013 events3 affected164 at risk
Renal infarct	Renal and urinary disorders	MedDRA version 25.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0010 events0 affected164 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.1	Systematic Assessment	EG0002 events2 affected167 at risk EG0011 events1 affected164 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0010 events0 affected164 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0011 events1 affected164 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.1	Systematic Assessment	EG0002 events2 affected167 at risk EG0011 events1 affected164 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0010 events0 affected164 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA version 25.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0010 events0 affected164 at risk
Dermatomyositis	Skin and subcutaneous tissue disorders	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected164 at risk
Embolism	Vascular disorders	MedDRA version 25.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0010 events0 affected164 at risk
Thrombosis	Vascular disorders	MedDRA version 25.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0010 events0 affected164 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA version 25.1	Systematic Assessment	EG00080 events65 affected167 at risk EG00189 events64 affected164 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA version 25.1	Systematic Assessment	EG00029 events17 affected167 at risk EG00146 events23 affected164 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA version 25.1	Systematic Assessment	EG000123 events59 affected167 at risk EG001141 events65 affected164 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA version 25.1	Systematic Assessment	EG0006 events5 affected167 at risk EG00116 events13 affected164 at risk
Hypothyroidism	Endocrine disorders	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG00122 events22 affected164 at risk
Dry eye	Eye disorders	MedDRA version 25.1	Systematic Assessment	EG0006 events6 affected167 at risk EG00113 events13 affected164 at risk
Lacrimation increased	Eye disorders	MedDRA version 25.1	Systematic Assessment	EG00018 events18 affected167 at risk EG00121 events18 affected164 at risk
Vision blurred	Eye disorders	MedDRA version 25.1	Systematic Assessment	EG00012 events11 affected167 at risk EG00116 events16 affected164 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA version 25.1	Systematic Assessment	EG00021 events16 affected167 at risk EG00129 events23 affected164 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA version 25.1	Systematic Assessment	EG00016 events13 affected167 at risk EG00123 events21 affected164 at risk
Constipation	Gastrointestinal disorders	MedDRA version 25.1	Systematic Assessment	EG00064 events55 affected167 at risk EG00174 events51 affected164 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA version 25.1	Systematic Assessment	EG000117 events74 affected167 at risk EG001110 events74 affected164 at risk
Dry mouth	Gastrointestinal disorders	MedDRA version 25.1	Systematic Assessment	EG0006 events5 affected167 at risk EG00111 events10 affected164 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA version 25.1	Systematic Assessment	EG00023 events21 affected167 at risk EG00122 events19 affected164 at risk
Nausea	Gastrointestinal disorders	MedDRA version 25.1	Systematic Assessment	EG000189 events110 affected167 at risk EG001218 events108 affected164 at risk
Stomatitis	Gastrointestinal disorders	MedDRA version 25.1	Systematic Assessment	EG00032 events29 affected167 at risk EG00148 events40 affected164 at risk
Vomiting	Gastrointestinal disorders	MedDRA version 25.1	Systematic Assessment	EG00070 events51 affected167 at risk EG001105 events63 affected164 at risk
Asthenia	General disorders	MedDRA version 25.1	Systematic Assessment	EG00040 events36 affected167 at risk EG00166 events42 affected164 at risk
Fatigue	General disorders	MedDRA version 25.1	Systematic Assessment	EG00086 events65 affected167 at risk EG00194 events65 affected164 at risk
Malaise	General disorders	MedDRA version 25.1	Systematic Assessment	EG00018 events17 affected167 at risk EG00135 events15 affected164 at risk
Mucosal inflammation	General disorders	MedDRA version 25.1	Systematic Assessment	EG00019 events15 affected167 at risk EG00124 events18 affected164 at risk
Oedema peripheral	General disorders	MedDRA version 25.1	Systematic Assessment	EG00027 events24 affected167 at risk EG00130 events24 affected164 at risk
Pain	General disorders	MedDRA version 25.1	Systematic Assessment	EG00011 events11 affected167 at risk EG00122 events20 affected164 at risk
Pyrexia	General disorders	MedDRA version 25.1	Systematic Assessment	EG00025 events21 affected167 at risk EG00155 events37 affected164 at risk
Nasopharyngitis	Infections and infestations	MedDRA version 25.1	Systematic Assessment	EG00017 events14 affected167 at risk EG00129 events23 affected164 at risk
Paronychia	Infections and infestations	MedDRA version 25.1	Systematic Assessment	EG00021 events21 affected167 at risk EG00120 events19 affected164 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA version 25.1	Systematic Assessment	EG00016 events16 affected167 at risk EG00130 events23 affected164 at risk
Urinary tract infection	Infections and infestations	MedDRA version 25.1	Systematic Assessment	EG00011 events11 affected167 at risk EG00125 events18 affected164 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA version 25.1	Systematic Assessment	EG00016 events10 affected167 at risk EG00128 events16 affected164 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA version 25.1	Systematic Assessment	EG0002 events2 affected167 at risk EG00117 events14 affected164 at risk
Radiation skin injury	Injury, poisoning and procedural complications	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG00132 events32 affected164 at risk
Alanine aminotransferase increased	Investigations	MedDRA version 25.1	Systematic Assessment	EG00053 events35 affected167 at risk EG00163 events39 affected164 at risk
Aspartate aminotransferase increased	Investigations	MedDRA version 25.1	Systematic Assessment	EG00044 events28 affected167 at risk EG00164 events37 affected164 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA version 25.1	Systematic Assessment	EG0004 events4 affected167 at risk EG00119 events14 affected164 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA version 25.1	Systematic Assessment	EG0007 events7 affected167 at risk EG00111 events10 affected164 at risk
Neutrophil count decreased	Investigations	MedDRA version 25.1	Systematic Assessment	EG00067 events30 affected167 at risk EG00160 events29 affected164 at risk
Weight decreased	Investigations	MedDRA version 25.1	Systematic Assessment	EG0008 events8 affected167 at risk EG00117 events15 affected164 at risk
White blood cell count decreased	Investigations	MedDRA version 25.1	Systematic Assessment	EG00035 events15 affected167 at risk EG00133 events14 affected164 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA version 25.1	Systematic Assessment	EG00036 events33 affected167 at risk EG00137 events28 affected164 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA version 25.1	Systematic Assessment	EG0009 events7 affected167 at risk EG00124 events12 affected164 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA version 25.1	Systematic Assessment	EG00061 events42 affected167 at risk EG00176 events50 affected164 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA version 25.1	Systematic Assessment	EG00024 events20 affected167 at risk EG00127 events24 affected164 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA version 25.1	Systematic Assessment	EG00012 events11 affected167 at risk EG00114 events13 affected164 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA version 25.1	Systematic Assessment	EG00049 events40 affected167 at risk EG00186 events51 affected164 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA version 25.1	Systematic Assessment	EG00026 events19 affected167 at risk EG00136 events27 affected164 at risk
Dizziness	Nervous system disorders	MedDRA version 25.1	Systematic Assessment	EG00016 events15 affected167 at risk EG00133 events20 affected164 at risk
Dysgeusia	Nervous system disorders	MedDRA version 25.1	Systematic Assessment	EG00027 events25 affected167 at risk EG00120 events16 affected164 at risk
Headache	Nervous system disorders	MedDRA version 25.1	Systematic Assessment	EG00046 events36 affected167 at risk EG00186 events51 affected164 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA version 25.1	Systematic Assessment	EG00042 events34 affected167 at risk EG00148 events40 affected164 at risk
Paraesthesia	Nervous system disorders	MedDRA version 25.1	Systematic Assessment	EG00022 events19 affected167 at risk EG00113 events12 affected164 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA version 25.1	Systematic Assessment	EG00045 events42 affected167 at risk EG00165 events58 affected164 at risk
Polyneuropathy	Nervous system disorders	MedDRA version 25.1	Systematic Assessment	EG00015 events14 affected167 at risk EG00110 events10 affected164 at risk
Taste disorder	Nervous system disorders	MedDRA version 25.1	Systematic Assessment	EG00013 events13 affected167 at risk EG00111 events10 affected164 at risk
Anxiety	Psychiatric disorders	MedDRA version 25.1	Systematic Assessment	EG00011 events11 affected167 at risk EG00113 events12 affected164 at risk
Depression	Psychiatric disorders	MedDRA version 25.1	Systematic Assessment	EG0006 events6 affected167 at risk EG00111 events11 affected164 at risk
Insomnia	Psychiatric disorders	MedDRA version 25.1	Systematic Assessment	EG00030 events29 affected167 at risk EG00161 events49 affected164 at risk
Breast pain	Reproductive system and breast disorders	MedDRA version 25.1	Systematic Assessment	EG00015 events15 affected167 at risk EG00119 events17 affected164 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.1	Systematic Assessment	EG00039 events32 affected167 at risk EG00152 events41 affected164 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.1	Systematic Assessment	EG00022 events20 affected167 at risk EG00125 events23 affected164 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.1	Systematic Assessment	EG00026 events24 affected167 at risk EG00126 events25 affected164 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.1	Systematic Assessment	EG00019 events18 affected167 at risk EG00120 events19 affected164 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.1	Systematic Assessment	EG0000 events0 affected167 at risk EG00112 events10 affected164 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA version 25.1	Systematic Assessment	EG000132 events129 affected167 at risk EG001127 events125 affected164 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA version 25.1	Systematic Assessment	EG00010 events10 affected167 at risk EG0018 events6 affected164 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA version 25.1	Systematic Assessment	EG00013 events13 affected167 at risk EG00120 events18 affected164 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA version 25.1	Systematic Assessment	EG0005 events5 affected167 at risk EG00117 events15 affected164 at risk
Nail discolouration	Skin and subcutaneous tissue disorders	MedDRA version 25.1	Systematic Assessment	EG00029 events29 affected167 at risk EG00128 events26 affected164 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA version 25.1	Systematic Assessment	EG00010 events10 affected167 at risk EG00122 events21 affected164 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA version 25.1	Systematic Assessment	EG00031 events25 affected167 at risk EG00149 events36 affected164 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA version 25.1	Systematic Assessment	EG00053 events42 affected167 at risk EG00168 events52 affected164 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA version 25.1	Systematic Assessment	EG00014 events12 affected167 at risk EG00112 events12 affected164 at risk
Hot flush	Vascular disorders	MedDRA version 25.1	Systematic Assessment	EG00020 events17 affected167 at risk EG00132 events28 affected164 at risk
Hypertension	Vascular disorders	MedDRA version 25.1	Systematic Assessment	EG00029 events17 affected167 at risk EG00127 events15 affected164 at risk

ID	Term
D001943	Breast Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D003630	Daunorubicin
D018943	Anthracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D011083	Polycyclic Compounds
D000617	Aminoglycosides
D006027	Glycosides
D002241	Carbohydrates
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D063088	Phosphoramides
D009943	Organophosphorus Compounds
D016179	Granulocyte Colony-Stimulating Factor
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates
D016298	Hematopoietic Cell Growth Factors
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D011506	Proteins
D001685	Biological Factors

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	28	167	36	167	167	167
EG001	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.	16	164	59	164	162	164

ID	Term
C000594389	atezolizumab
C520255	130-nm albumin-bound paclitaxel
D004317	Doxorubicin
D003520	Cyclophosphamide
D000069585	Filgrastim
C455861	pegfilgrastim