Trial Outcomes & Findings for Liposomal Doxorubicin, Bevacizumab, and Everolimus in Patients With Locally Advanced TNBC With Tumors Predicted Insensitive to Standard Chemotherapy; A Moonshot Initiative (NCT NCT02456857)
NCT ID: NCT02456857
Last Updated: 2024-02-13
Results Overview
Residual Disease at the time of surgery
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
up to 3 years
Results posted on
2024-02-13
Participant Flow
Recruitment took place in the Breast Medical Oncology clinics of MD Anderson Cancer Center locations during January of 2016 through January of 2020
Participant milestones
| Measure |
Liposomal Doxorubicin + Bevacizumab + Everolimus
Liposomal doxorubicin IV 30mg/m2 + Bevacizumab IV (10-15mg/kg) + Everolimus PO 7.5mg
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Liposomal Doxorubicin + Bevacizumab + Everolimus
Liposomal doxorubicin IV 30mg/m2 + Bevacizumab IV (10-15mg/kg) + Everolimus PO 7.5mg
|
|---|---|
|
Overall Study
Disease Progression
|
4
|
Baseline Characteristics
Liposomal Doxorubicin, Bevacizumab, and Everolimus in Patients With Locally Advanced TNBC With Tumors Predicted Insensitive to Standard Chemotherapy; A Moonshot Initiative
Baseline characteristics by cohort
| Measure |
Liposomal Doxorubicin + Bevacizumab + Everolimus
n=17 Participants
Liposomal doxorubicin IV 30mg/m2 + Bevacizumab IV (10-15mg/kg) + Everolimus PO 7.5mg
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 3 yearsResidual Disease at the time of surgery
Outcome measures
| Measure |
Liposomal Doxorubicin + Bevacizumab + Everolimus
n=17 Participants
Liposomal doxorubicin IV 30mg/m2 + Bevacizumab IV (10-15mg/kg) + Everolimus PO 7.5mg
|
|---|---|
|
RCB Status
pcR (Best)
|
0 participants
|
|
RCB Status
RCB-I
|
1 participants
|
|
RCB Status
RCB-II
|
13 participants
|
|
RCB Status
RCB-III (Worst)
|
3 participants
|
Adverse Events
Liposomal Doxorubicin + Bevacizumab + Everolimus
Serious events: 5 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Liposomal Doxorubicin + Bevacizumab + Everolimus
n=17 participants at risk
Liposomal doxorubicin IV 30mg/m2 + Bevacizumab IV (10-15mg/kg) + Everolimus PO 7.5mg
|
|---|---|
|
Cardiac disorders
Hypertension
|
5.9%
1/17 • Number of events 1 • 3 years
|
|
Infections and infestations
Cellulitis
|
5.9%
1/17 • Number of events 1 • 3 years
|
|
Infections and infestations
Skin infection
|
5.9%
1/17 • Number of events 1 • 3 years
|
|
General disorders
Pain
|
5.9%
1/17 • Number of events 2 • 3 years
|
|
General disorders
Allergic reaction
|
5.9%
1/17 • Number of events 1 • 3 years
|
|
General disorders
Fever
|
5.9%
1/17 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Liposomal Doxorubicin + Bevacizumab + Everolimus
n=17 participants at risk
Liposomal doxorubicin IV 30mg/m2 + Bevacizumab IV (10-15mg/kg) + Everolimus PO 7.5mg
|
|---|---|
|
Investigations
Neutrophil Count Decreased
|
23.5%
4/17 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
17.6%
3/17 • 3 years
|
|
Gastrointestinal disorders
Oral mucositis
|
29.4%
5/17 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.8%
2/17 • 3 years
|
|
Nervous system disorders
Headache
|
11.8%
2/17 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
5.9%
1/17 • 3 years
|
|
Infections and infestations
High cholesterol
|
5.9%
1/17 • 3 years
|
|
Metabolism and nutrition disorders
Creatinine increased
|
5.9%
1/17 • 3 years
|
|
General disorders
Anxiety
|
5.9%
1/17 • 3 years
|
|
General disorders
Fatigue
|
5.9%
1/17 • 3 years
|
|
Metabolism and nutrition disorders
Hypergylcemia
|
5.9%
1/17 • 3 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
5.9%
1/17 • 3 years
|
|
General disorders
Insomnia
|
5.9%
1/17 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • 3 years
|
|
Skin and subcutaneous tissue disorders
Nail Loss
|
5.9%
1/17 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place