Trial Outcomes & Findings for Nab-Paclitaxel and Atezolizumab Before Surgery in Treating Patients With Triple Negative Breast Cancer (NCT NCT02530489)
NCT ID: NCT02530489
Last Updated: 2026-02-17
Results Overview
Residual Disease at the time of surgery
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
at the time of surgery, up to 12 weeks
Results posted on
2026-02-17
Participant Flow
Recruitment and enrollment took place in the Breast Medical Oncology clinics of MD Anderson Cancer Center locations from February of 2016 through January of 2021
Participant milestones
| Measure |
Atezolizumab Plus Nab-paclitaxel
Patients received atezolizumab (1200 mg IV, Q3weeks × 4) and nab-paclitaxel (100 mg/m2 IV,Q1 week × 12) as the second phase of NAT before undergoing surgery followed by adjuvant atezolizumab (1200 mg IV, Q3 weeks,×4)
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Atezolizumab Plus Nab-paclitaxel
Patients received atezolizumab (1200 mg IV, Q3weeks × 4) and nab-paclitaxel (100 mg/m2 IV,Q1 week × 12) as the second phase of NAT before undergoing surgery followed by adjuvant atezolizumab (1200 mg IV, Q3 weeks,×4)
|
|---|---|
|
Overall Study
Adverse Event
|
7
|
Baseline Characteristics
Nab-Paclitaxel and Atezolizumab Before Surgery in Treating Patients With Triple Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Atezolizumab Plus Nab-paclitaxel
n=37 Participants
Patients received atezolizumab (1200 mg IV, Q3weeks × 4) and nab-paclitaxel (100 mg/m2 IV,Q1 week × 12) as the second phase of NAT before undergoing surgery followed by adjuvant atezolizumab (1200 mg IV, Q3 weeks,×4)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=25 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=25 Participants
|
|
Age, Continuous
|
53.8 years
n=25 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=25 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=25 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=25 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=25 Participants
|
PRIMARY outcome
Timeframe: at the time of surgery, up to 12 weeksResidual Disease at the time of surgery
Outcome measures
| Measure |
Atezolizumab and Nab-paclitaxel
n=37 Participants
Atezolizumab and nab-paclitaxel
|
|---|---|
|
RCB Status
pcR
|
12 Participants
|
|
RCB Status
RCB
|
5 Participants
|
|
RCB Status
RCB-2/RCB-3
|
20 Participants
|
Adverse Events
Atezolizumab and Nab-paclitaxel
Serious events: 16 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atezolizumab and Nab-paclitaxel
n=37 participants at risk
Atezolizumab and nab-paclitaxel
|
|---|---|
|
Renal and urinary disorders
acute kidney injury
|
5.4%
2/37 • Number of events 2 • 5 years
|
|
Investigations
creatinine increased
|
2.7%
1/37 • Number of events 1 • 5 years
|
|
General disorders
fever
|
10.8%
4/37 • Number of events 4 • 5 years
|
|
Infections and infestations
urinary tract infection
|
2.7%
1/37 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
neutrophil count decreased
|
5.4%
2/37 • 5 years
|
|
Infections and infestations
lung infection
|
2.7%
1/37 • 5 years
|
|
General disorders
localized edema
|
2.7%
1/37 • 5 years
|
|
Nervous system disorders
syncope
|
2.7%
1/37 • 5 years
|
|
Infections and infestations
abdominal infection
|
2.7%
1/37 • 5 years
|
|
Infections and infestations
autoimmune hepatitis
|
2.7%
1/37 • 5 years
|
|
General disorders
hyperthyroidism
|
2.7%
1/37 • 5 years
|
Other adverse events
| Measure |
Atezolizumab and Nab-paclitaxel
n=37 participants at risk
Atezolizumab and nab-paclitaxel
|
|---|---|
|
Investigations
Neutrophil Count decreased
|
37.8%
14/37 • Number of events 17 • 5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
48.6%
18/37 • Number of events 21 • 5 years
|
|
General disorders
Fatigue
|
67.6%
25/37 • Number of events 27 • 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
54.1%
20/37 • Number of events 23 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash Maculopapular
|
27.0%
10/37 • Number of events 11 • 5 years
|
|
Gastrointestinal disorders
Mucositis Oral
|
10.8%
4/37 • Number of events 5 • 5 years
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
13.5%
5/37 • Number of events 5 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place