Trial Outcomes & Findings for Exemestane With Sunitinib (SUTENT®) in Metastatic Breast Cancer (NCT NCT00905021)
NCT ID: NCT00905021
Last Updated: 2020-07-24
Results Overview
Time from the first day of treatment to date of progression in weeks
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
4 participants
Primary outcome timeframe
Medical evaluation every 4 weeks;The study does not have a fixed time frame for each participant. Duration of therapy depends on individule response, evidence of disease progression and tolerance
Results posted on
2020-07-24
Participant Flow
Participant milestones
| Measure |
Exemestane Plus Sutent
All patients enrolled on the study will receive treatment as follows:
1. Exemestane 25 mg by mouth every day.
2. Sunitinib 37.5 mg by mouth every day.
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Exemestane Plus Sutent
All patients enrolled on the study will receive treatment as follows:
1. Exemestane 25 mg by mouth every day.
2. Sunitinib 37.5 mg by mouth every day.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Exemestane With Sunitinib (SUTENT®) in Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Exemestane Plus Sutent
n=4 Participants
All patients enrolled on the study will receive treatment as follows:
1. Exemestane 25 mg by mouth every day.
2. Sunitinib 37.5 mg by mouth every day.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Medical evaluation every 4 weeks;The study does not have a fixed time frame for each participant. Duration of therapy depends on individule response, evidence of disease progression and tolerancePopulation: 2 patients developed disease progression.
Time from the first day of treatment to date of progression in weeks
Outcome measures
| Measure |
Exemestane Plus Sunitinib
n=2 Participants
All patients enrolled on the study will receive treatment as follows:
1. Exemestane 25 mg by mouth every day.
2. Sunitinib 37.5 mg by mouth every day.
|
|---|---|
|
Time to Disease Progression in Weeks
|
11.1 week
Interval 10.9 to 11.3
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: The study was terminated early before target accrual. 4 patients were enrolled and received treatment. 2 patients developed progression and 2 patients was drop-off the study due to adverse events.
Outcome measures
| Measure |
Exemestane Plus Sunitinib
n=4 Participants
All patients enrolled on the study will receive treatment as follows:
1. Exemestane 25 mg by mouth every day.
2. Sunitinib 37.5 mg by mouth every day.
|
|---|---|
|
Obtain Assessments of Overall Response Rate, Clinical Benefit Rate, and Overall Survival
|
NA paticipants
The study was terminated early before target accrual and the secondary analyses were not conducted due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: The study was terminated early before target accrual. 4 patients were enrolled and received treatment. 2 patients developed progression and 2 patients was drop-off the study due to adverse events.
Outcome measures
| Measure |
Exemestane Plus Sunitinib
n=4 Participants
All patients enrolled on the study will receive treatment as follows:
1. Exemestane 25 mg by mouth every day.
2. Sunitinib 37.5 mg by mouth every day.
|
|---|---|
|
Determine the Safety and Tolerability
|
NA Participants
The study was terminated early before target accrual and the secondary analyses were not conducted due to insufficient number of participants.
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: The study was terminated early before target accrual. 4 patients were enrolled and received treatment. 2 patients developed progression and 2 patients was drop-off the study due to adverse events.
Outcome measures
| Measure |
Exemestane Plus Sunitinib
n=4 Participants
All patients enrolled on the study will receive treatment as follows:
1. Exemestane 25 mg by mouth every day.
2. Sunitinib 37.5 mg by mouth every day.
|
|---|---|
|
Study Molecular Changes in Tissue Biopsies, Circulating Tumor Cells, and Circulating Endothelial Cells
|
NA cell
The study was terminated early before target accrual. No correlative study was performed.
|
Adverse Events
Exemestane Plus Sutent
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exemestane Plus Sutent
n=4 participants at risk
All patients enrolled on the study will receive treatment as follows:
1. Exemestane 25 mg by mouth every day.
2. Sunitinib 37.5 mg by mouth every day.
|
|---|---|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
25.0%
1/4 • Number of events 1 • Medical evaluation every 4 weeks. The study does not have a fixed time frame for each participant. Duration of therapy depends on individule response, evidence of disease progression and tolerance.
|
Other adverse events
| Measure |
Exemestane Plus Sutent
n=4 participants at risk
All patients enrolled on the study will receive treatment as follows:
1. Exemestane 25 mg by mouth every day.
2. Sunitinib 37.5 mg by mouth every day.
|
|---|---|
|
Blood and lymphatic system disorders
leukopenia
|
100.0%
4/4 • Number of events 4 • Medical evaluation every 4 weeks. The study does not have a fixed time frame for each participant. Duration of therapy depends on individule response, evidence of disease progression and tolerance.
|
|
Cardiac disorders
Hypertension
|
75.0%
3/4 • Number of events 4 • Medical evaluation every 4 weeks. The study does not have a fixed time frame for each participant. Duration of therapy depends on individule response, evidence of disease progression and tolerance.
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
25.0%
1/4 • Number of events 1 • Medical evaluation every 4 weeks. The study does not have a fixed time frame for each participant. Duration of therapy depends on individule response, evidence of disease progression and tolerance.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
25.0%
1/4 • Number of events 1 • Medical evaluation every 4 weeks. The study does not have a fixed time frame for each participant. Duration of therapy depends on individule response, evidence of disease progression and tolerance.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin
|
50.0%
2/4 • Number of events 2 • Medical evaluation every 4 weeks. The study does not have a fixed time frame for each participant. Duration of therapy depends on individule response, evidence of disease progression and tolerance.
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • Medical evaluation every 4 weeks. The study does not have a fixed time frame for each participant. Duration of therapy depends on individule response, evidence of disease progression and tolerance.
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 1 • Medical evaluation every 4 weeks. The study does not have a fixed time frame for each participant. Duration of therapy depends on individule response, evidence of disease progression and tolerance.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
25.0%
1/4 • Number of events 1 • Medical evaluation every 4 weeks. The study does not have a fixed time frame for each participant. Duration of therapy depends on individule response, evidence of disease progression and tolerance.
|
|
Gastrointestinal disorders
Mucositis/stomatitis
|
50.0%
2/4 • Number of events 2 • Medical evaluation every 4 weeks. The study does not have a fixed time frame for each participant. Duration of therapy depends on individule response, evidence of disease progression and tolerance.
|
|
Eye disorders
Ocular/Visual
|
25.0%
1/4 • Number of events 1 • Medical evaluation every 4 weeks. The study does not have a fixed time frame for each participant. Duration of therapy depends on individule response, evidence of disease progression and tolerance.
|
|
General disorders
pain
|
25.0%
1/4 • Number of events 2 • Medical evaluation every 4 weeks. The study does not have a fixed time frame for each participant. Duration of therapy depends on individule response, evidence of disease progression and tolerance.
|
|
Blood and lymphatic system disorders
platelets
|
50.0%
2/4 • Number of events 2 • Medical evaluation every 4 weeks. The study does not have a fixed time frame for each participant. Duration of therapy depends on individule response, evidence of disease progression and tolerance.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
50.0%
2/4 • Number of events 2 • Medical evaluation every 4 weeks. The study does not have a fixed time frame for each participant. Duration of therapy depends on individule response, evidence of disease progression and tolerance.
|
|
Vascular disorders
Thrombosis/embolism
|
25.0%
1/4 • Number of events 1 • Medical evaluation every 4 weeks. The study does not have a fixed time frame for each participant. Duration of therapy depends on individule response, evidence of disease progression and tolerance.
|
|
Endocrine disorders
Thyroid function, low
|
50.0%
2/4 • Number of events 2 • Medical evaluation every 4 weeks. The study does not have a fixed time frame for each participant. Duration of therapy depends on individule response, evidence of disease progression and tolerance.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place