Trial Outcomes & Findings for Efficacy Study of Dasatinib in Locally Advanced Triple-Negative Breast Cancer Patients (NCT NCT00817531)
NCT ID: NCT00817531
Last Updated: 2012-08-31
Results Overview
The clinical response was assessed using RECIST and based on the changes in the longest diameter of the target lesion measured. Complete Response (CR), Disappearance of the target lesion; Partial Response (PR), \>=30% decrease in the diameter of target lesion compared to baseline; Progressive disease (PD), \>= 20% increase in the diameter of target lession, taking as reference the smallest diameter recorded since the baseline measurement or the appearance of new lesion; Stable disease (SD), neither sufficient shrinkage as PR or sufficient increase as PD.
TERMINATED
PHASE2
22 participants
Assessment at pre-surgery or 3 to 4 weeks of treatment.
2012-08-31
Participant Flow
The study started recruitment in December 2010. Baylor college of Medicine is the only site of the study.
each patient have to be eligible and pass all screening tests after signing the consent to be enrolled in the study.
Participant milestones
| Measure |
Dasatinib
Patients took Dasatinib 100mg daily
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Dasatinib
Patients took Dasatinib 100mg daily
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
Baseline Characteristics
Efficacy Study of Dasatinib in Locally Advanced Triple-Negative Breast Cancer Patients
Baseline characteristics by cohort
| Measure |
Dasatinib
n=22 Participants
Patients took Dasatinib 100mg daily
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
|
Age Continuous
|
48.5 years
STANDARD_DEVIATION 12.7 • n=93 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Assessment at pre-surgery or 3 to 4 weeks of treatment.Population: All patients started the treatment will be included in the analysis
The clinical response was assessed using RECIST and based on the changes in the longest diameter of the target lesion measured. Complete Response (CR), Disappearance of the target lesion; Partial Response (PR), \>=30% decrease in the diameter of target lesion compared to baseline; Progressive disease (PD), \>= 20% increase in the diameter of target lession, taking as reference the smallest diameter recorded since the baseline measurement or the appearance of new lesion; Stable disease (SD), neither sufficient shrinkage as PR or sufficient increase as PD.
Outcome measures
| Measure |
Dasatinib
n=22 Participants
Dasatinib 100 mg once daily
|
|---|---|
|
Clinical Efficacy
Partial Response (PR)
|
2 participants
|
|
Clinical Efficacy
Stable Disease (SD)
|
15 participants
|
|
Clinical Efficacy
Progression Disease (PD)
|
5 participants
|
Adverse Events
Dasatinib
Serious adverse events
| Measure |
Dasatinib
n=22 participants at risk
Patients took Dasatinib 100mg daily
|
|---|---|
|
Cardiac disorders
Cardiac infarction
|
4.5%
1/22 • Number of events 1 • 3-4 weeks
Following the patient's written consent to participate in the study, then to the end of 3-4 week treatment
|
Other adverse events
| Measure |
Dasatinib
n=22 participants at risk
Patients took Dasatinib 100mg daily
|
|---|---|
|
Metabolism and nutrition disorders
ALT, SGPT(serum glutamic pyruvic transaminase)
|
40.9%
9/22 • Number of events 10 • 3-4 weeks
Following the patient's written consent to participate in the study, then to the end of 3-4 week treatment
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
50.0%
11/22 • Number of events 12 • 3-4 weeks
Following the patient's written consent to participate in the study, then to the end of 3-4 week treatment
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
9.1%
2/22 • Number of events 2 • 3-4 weeks
Following the patient's written consent to participate in the study, then to the end of 3-4 week treatment
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
31.8%
7/22 • Number of events 7 • 3-4 weeks
Following the patient's written consent to participate in the study, then to the end of 3-4 week treatment
|
|
Gastrointestinal disorders
Constipation
|
9.1%
2/22 • Number of events 2 • 3-4 weeks
Following the patient's written consent to participate in the study, then to the end of 3-4 week treatment
|
|
Gastrointestinal disorders
Diarrhea
|
13.6%
3/22 • Number of events 3 • 3-4 weeks
Following the patient's written consent to participate in the study, then to the end of 3-4 week treatment
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
18.2%
4/22 • Number of events 4 • 3-4 weeks
Following the patient's written consent to participate in the study, then to the end of 3-4 week treatment
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
22.7%
5/22 • Number of events 5 • 3-4 weeks
Following the patient's written consent to participate in the study, then to the end of 3-4 week treatment
|
|
Blood and lymphatic system disorders
Hemoglobin
|
27.3%
6/22 • Number of events 6 • 3-4 weeks
Following the patient's written consent to participate in the study, then to the end of 3-4 week treatment
|
|
Infections and infestations
Infection
|
13.6%
3/22 • Number of events 4 • 3-4 weeks
Following the patient's written consent to participate in the study, then to the end of 3-4 week treatment
|
|
Gastrointestinal disorders
Nausea
|
18.2%
4/22 • Number of events 5 • 3-4 weeks
Following the patient's written consent to participate in the study, then to the end of 3-4 week treatment
|
|
General disorders
Pain
|
68.2%
15/22 • Number of events 17 • 3-4 weeks
Following the patient's written consent to participate in the study, then to the end of 3-4 week treatment
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
18.2%
4/22 • Number of events 4 • 3-4 weeks
Following the patient's written consent to participate in the study, then to the end of 3-4 week treatment
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
9.1%
2/22 • Number of events 3 • 3-4 weeks
Following the patient's written consent to participate in the study, then to the end of 3-4 week treatment
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
2/22 • Number of events 3 • 3-4 weeks
Following the patient's written consent to participate in the study, then to the end of 3-4 week treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place