Trial Outcomes & Findings for A Study of Lapatinib in Combination With Everolimus in Patients With Advanced, Triple Negative Breast Cancer (NCT NCT01272141)
NCT ID: NCT01272141
Last Updated: 2014-09-22
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Tumor assessment for all lesions must be performed by CT scan every 8 weeks while on study.
Results posted on
2014-09-22
Participant Flow
Participant milestones
| Measure |
Arm A: Lapatinib Plus Everolimus
Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily
Everolimus: 5mg by mouth daily
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Lapatinib in Combination With Everolimus in Patients With Advanced, Triple Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm A: Lapatinib Plus Everolimus
n=5 Participants
Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily
Everolimus: 5mg by mouth daily
|
|---|---|
|
Age, Customized
41-45 years
|
2 participants
n=5 Participants
|
|
Age, Customized
46-50 years
|
2 participants
n=5 Participants
|
|
Age, Customized
51-55 years
|
1 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Tumor assessment for all lesions must be performed by CT scan every 8 weeks while on study.Population: No data were collected due to early termination.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Safety assessments will be performed every four weeks while the patient remains on study.Population: No data were collected due to early termination.
Outcome measures
Outcome data not reported
Adverse Events
Arm A: Lapatinib Plus Everolimus
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A: Lapatinib Plus Everolimus
n=5 participants at risk
Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily
Everolimus: 5mg by mouth daily
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath due to pulmonary embolism
|
20.0%
1/5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place