A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130)

OS was defined as the time from the date of randomization to the date of death from any cause.

Time frame: Baseline until death due to any cause (up to approximately 58 months)

Population: The PD-L1-selected subpopulation is defined as patients in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization.

OS was defined as the time from the date of randomization to the date of death from any cause.

Time frame: Baseline until death due to any cause (up to approximately 58 months)

Population: The ITT population is defined as all randomized patients, whether or not the assigned study treatment was received.

PFS was defined as the time from randomization to the occurrence of disease progression, as determined by investigators from tumor assessments per RECIST v1.1, or death from any cause, whichever occurred first.

Time frame: Baseline up to approximately 34 months

Population: The PD-L1-selected subpopulation is defined as patients in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization.

PFS was defined as the time from randomization to the occurrence of disease progression, as determined by investigators from tumor assessments per RECIST v1.1, or death from any cause, whichever occurred first.

Time frame: Baseline up to approximately 34 months

Population: The ITT population is defined as all randomized patients, whether or not the assigned study treatment was received.

DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause, whichever occurred first.

Time frame: Baseline up to approximately 34 months

Population: The duration of response (DOR)-evaluable population is defined as patients with an objective response.

DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause, whichever occurred first.

Time frame: Baseline up to approximately 34 months

Population: The duration of response (DOR)-evaluable population is defined as patients with an objective response.

Maximum serum concentration for atezolizumab.

Time frame: Cycle 1 Day 1 (Cycle = 28 days)

Population: The pharmacokinetic (PK)-evaluable population is defined as all patients who received any dose of study medication and who have at least one post-baseline PK sample available.

Minimum serum concentration for atezolizumab.

Time frame: Day 27 of Cycle 1, 2, 3, and 7 (Cycle = 28 days)

Population: The pharmacokinetic (PK)-evaluable population is defined as all patients who received any dose of study medication and who have at least one post-baseline PK sample available.

An objective response was defined for participants with measurable disease at baseline as either a partial response (PR) or a complete response (CR) using RECIST v1.1.

Time frame: Baseline up to approximately 34 months

Population: The ORR-evaluable population is defined as patients in the ITT population with measurable disease at baseline.

An objective response was defined for participants with measurable disease at baseline as either a partial response (PR) or a complete response (CR) using RECIST v1.1.

Time frame: Baseline up to approximately 34 months

Population: The PD-L1-ORR-evaluable population is defined as patients in the PD-L1-selected subpopulation with measurable disease at baseline.

Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab

Time frame: Baseline up to approximately 53 months

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

Percentage of participants with at least one adverse event.

Time frame: Baseline up to to the data cutoff date: 31 August 2021 (up to approximately 74 months)

Population: The safety-evaluable population is defined as participants who received any amount of any study drug.

Plasma Concentrations of Total Paclitaxel

Time frame: Pre-dose (Hour 0) on Cycle 1 Day 1, pre-dose (Hour 0), 5-10 minutes before end of nab-paclitaxel infusion, 1 hour after end of nab-paclitaxel infusion (infusion duration = 30 minutes) on Cycle 3 Day 1 (Cycle = 28 days)

Population: The pharmacokinetic (PK)-evaluable population is defined as all patients who received any dose of study medication and who have at least one post-baseline PK sample available.

Deterioration in GHS/HRQoL (Items 29, 30 of the EORTC QLQ C30) was defined by the following two criteria: 1. The time from randomization to the first time the participant's GHS/HRQoL scale score showed a \>=10-point decrease from the baseline scale score. A 10-point change was defined as the minimally important difference (MID). 2. The score decrease of \>= 10-points from baseline was held for at least two consecutive cycles, or an initial score decrease of \>= 10-points was followed by death or treatment discontinuation within 3 weeks from the last assessment.

Time frame: Baseline up to approximately 58 months

Population: The patient-reported outcome (PRO)-evaluable population is defined as patients in the ITT population with a baseline and ≥1 post-baseline PRO assessment.

Deterioration in GHS/HRQoL (Items 29, 30 of the EORTC QLQ C30) was defined by the following two criteria: 1. The time from randomization to the first time the participants's GHS/HRQoL scale score showed a \>=10-point decrease from the baseline scale score. A 10-point change was defined as the minimally important difference (MID). 2. The score decrease of \>= 10-points from baseline was held for at least two consecutive cycles, or an initial score decrease of \>= 10-points was followed by death or treatment discontinuation within 3 weeks from the last assessment.

Time frame: Baseline up to approximately 58 months

Population: The patient-reported outcome (PRO)-evaluable population is defined as patients in the ITT population with a baseline and ≥1 post-baseline PRO assessment.