- Metastatic or locally advanced, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression
- No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC
- Eligible for taxane monotherapy (i.e., absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control)
- A representative formalin-fixed, paraffin-embedded tumor specimen in paraffin blocks, or at least 20 unstained slides with an associated pathology report documenting ER, PR, and HER2 negativity. Participants with fewer than 20 unstained slides available at baseline, and not fewer than 12 unstained slides will be eligible upon discussion with Medical Monitor
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Measurable disease as defined by RECIST v1.1
- Adequate hematologic and end-organ function.
- Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases
- Leptomeningeal disease
- Pregnancy or lactation
- History of autoimmune disease
- Prior allogeneic stem cell or solid organ transplantation
- Positive test for human immunodeficiency virus
- Active hepatitis B or hepatitis C
- Receipt of a live, attenuated vaccine within 4 weeks prior to randomization, during treatment, or within 5 months following the last dose of atezolizumab/placebo.
analisys of PFS (ITT)
ATEZ+nabpac
PLB+nabpac
HR (95% CI)
PD-L1 status (mo.)
Positive
7.5
5.0
0.64 (0.51–0.80)
Negative
5.6
5.6
0.95 (0.79–1.15)
Age
41 - 64 yr
6.7
5.5
0.84 (0.70–1.01)
≥ 65
9.1
6.2
0.69 (0.51–0.94)
ECOG performance-status score
0
7.4
5.7
0.78 (0.64–0.94)
1
5.6
4.5
0.82 (0.66–1.03)
Baseline disease status
Locally advanced
9.6
5.5
0.66 (0.40–1.09)
Metastatic
6.6
5.5
0.82 (0.71–0.96)
No. of metastatic sites
0-3
8.2
5.6
0.76 (0.64–0.91)
>3
4.0
3.7
0.89 (0.67–1.17)
Liver metastases
Yes
5.3
3.7
0.80 (0.62–1.04)
No
7.5
5.6
0.79 (0.66–0.94)
Lung metastases
Yes
5.7
5.5
0.87 (0.72–1.07)
No
8.2
5.5
0.74 (0.60–0.91)
Previous NADJ or ADJ chemo
Yes
7.2
5.6
0.85 (0.71–1.03)
No
7.0
5.4
0.72 (0.57–0.92)
Previous taxane treatment
Yes
5.7
5.5
0.80 (0.65–0.97)
No
7.2
5.5
0.81 (0.66–1.00)
Previous anthracycline treatment
Yes
6.4
5.5
0.90 (0.74–1.10)
No
7.3
5.5
0.70 (0.56–0.87)
analisys of PFS (PD-L1+)
ATEZ+nabpac
PLB+nabpac
HR (95% CI)
Age
41-64 yr
7.7
5.0
0.67 (0.50-0.90)
≥65 yr
9.4
5.5
0.48 (0.30-0.79)
ECOG PS
0
8.6
5.5
0.65 (0.48-0.88)
1
7.4
3.6
0.60 (0.42-0.86)
Baseline disease status
Locally advanced
9.6
5.5
0.44 (0.22-0.89)
Metastatic
7.4
3.9
0.66 (0.51-0.84)
No. of metastatic sites
0-3
8.7
5.5
0.66 (0.51-0.86)
>3
5.5
3.3
0.56 (0.35-0.91)
Liver metastases
Yes
5.4
3.4
0.71 (0.44-1.13)
No
9.0
5.5
0.61 (0.47-0.80)
Lung metastases
Yes
7.2
4.7
0.73 (0.53-1.01)
No
9.0
5.3
0.55 (0.39-0.77)
Previous NADJ or ADJ chemo
Yes
7.4
5.5
0.76 (0.57-1.01)
No
9.4
3.8
0.45 (0.30-0.67)
Previous taxane treatment
Yes
6.1
5.5
0.74 (0.54-1.01)
No
8.6
3.9
0.54 (0.38-0.76)
Previous anthracycline treatment
Yes
6.4
5.5
0.82 (0.60-1.11)
No
9.4
3.9
0.45 (0.31-0.65)
Bone metastases
Yes
5.7
3.6
0.62 (0.41-0.95)
No
8.6
5.5
0.63 (0.48-0.84)