Trial Outcomes & Findings for Nab-paclitaxel and Alpelisib for the Treatment of Anthracycline Refractory Triple Negative Breast Cancer With PIK3CA or PTEN Alterations (NCT NCT04216472)
NCT ID: NCT04216472
Last Updated: 2026-07-07
Results Overview
Will be assessed by the alpelisib in combination with nab-paclitaxel in the neoadjuvant setting will improve rates.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Up to 30 days
Results posted on
2026-07-07
Participant Flow
Recruitment and enrollment took place in the Breast Medical Oncology clinics of MD Anderson Cancer Center locations from July of 2020 through August of 2021
Participant milestones
| Measure |
Alpelisib Plus Nab-paclitaxel
Alpelisib 300mgPO qd plus nab-paclitaxel 100mg/m2 IV qw x 12 weeks
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Alpelisib Plus Nab-paclitaxel
Alpelisib 300mgPO qd plus nab-paclitaxel 100mg/m2 IV qw x 12 weeks
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Nab-paclitaxel and Alpelisib for the Treatment of Anthracycline Refractory Triple Negative Breast Cancer With PIK3CA or PTEN Alterations
Baseline characteristics by cohort
| Measure |
Alpelisib Plus Nab-paclitaxel
n=6 Participants
Alpelisib 300mgPO qd plus nab-paclitaxel 100mg/m2 IV qw x 12 weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=20 Participants
|
|
Age, Continuous
|
53.5 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Up to 30 daysWill be assessed by the alpelisib in combination with nab-paclitaxel in the neoadjuvant setting will improve rates.
Outcome measures
| Measure |
Alpelisib Plus Nab-paclitaxel
n=6 Participants
Alpelisib 300mgPO qd plus nab-paclitaxel 100mg/m2 IV qw x 12 weeks
|
|---|---|
|
Rate of Pathological Complete Response (pCR/RCB-0)
RCB-I
|
1 Participants
|
|
Rate of Pathological Complete Response (pCR/RCB-0)
RCB-II
|
5 Participants
|
Adverse Events
Alpelisib Plus Nab-paclitaxel
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alpelisib Plus Nab-paclitaxel
n=6 participants at risk
Alpelisib 300mgPO qd plus nab-paclitaxel 100mg/m2 IV qw x 12 weeks
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Number of events 1 • 11 months
|
Other adverse events
| Measure |
Alpelisib Plus Nab-paclitaxel
n=6 participants at risk
Alpelisib 300mgPO qd plus nab-paclitaxel 100mg/m2 IV qw x 12 weeks
|
|---|---|
|
Nervous system disorders
peripheral sensory neuropathy
|
16.7%
1/6 • Number of events 1 • 11 months
|
|
Skin and subcutaneous tissue disorders
rash maculopapular
|
16.7%
1/6 • Number of events 1 • 11 months
|
|
Gastrointestinal disorders
mucositis oral
|
16.7%
1/6 • Number of events 1 • 11 months
|
|
Metabolism and nutrition disorders
hyperglycemia
|
33.3%
2/6 • Number of events 2 • 11 months
|
Additional Information
Senthil Damodaran, MD PhD
The University of Texas MD Anderson Cancer Center
Phone: (832) 829-4307
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place