Trial Outcomes & Findings for Window of Opportunity Trial of Dasatinib in Operable Triple Negative Breast Cancers With nEGFR (NCT NCT02720185)
NCT ID: NCT02720185
Last Updated: 2022-06-03
Results Overview
An increase of at least 25% from baseline to post-dasatinib treatment will be considered significant. VECTRA is an automated pathology imaging system used to detect biomarkers in samples.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
7-10 days
Results posted on
2022-06-03
Participant Flow
Eligible patients were entered on study at the University of Wisconsin Carbone Cancer Center. Participants were enrolled from May 2017 to June 2020.
Participant milestones
| Measure |
Dasatinib 100mg
Dasatinib 100mg for 7-10 days until day prior to surgery
Dasatinib: 100mg oral once daily dasatinib taken for 7-10 days up to the day prior to planned surgery or research biopsy (neoadjuvant chemotherapy group)
Conventional Surgery: Undergo surgery
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Dasatinib 100mg
Dasatinib 100mg for 7-10 days until day prior to surgery
Dasatinib: 100mg oral once daily dasatinib taken for 7-10 days up to the day prior to planned surgery or research biopsy (neoadjuvant chemotherapy group)
Conventional Surgery: Undergo surgery
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Window of Opportunity Trial of Dasatinib in Operable Triple Negative Breast Cancers With nEGFR
Baseline characteristics by cohort
| Measure |
Dasatinib 100mg
n=5 Participants
Dasatinib 100mg for 7-10 days until day prior to surgery
Dasatinib: 100mg oral once daily dasatinib taken for 7-10 days up to the day prior to planned surgery or research biopsy (neoadjuvant chemotherapy group)
Conventional Surgery: Undergo surgery
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
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
|
1 Participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
2 Participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
1 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
1 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
0 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7-10 daysAn increase of at least 25% from baseline to post-dasatinib treatment will be considered significant. VECTRA is an automated pathology imaging system used to detect biomarkers in samples.
Outcome measures
| Measure |
Dasatinib 100mg
n=5 Participants
Dasatinib 100mg for 7-10 days until day prior to surgery
Dasatinib: 100mg oral once daily dasatinib taken for 7-10 days up to the day prior to planned surgery or research biopsy (neoadjuvant chemotherapy group)
Conventional Surgery: Undergo surgery
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Plasma Membrane Epidermal Growth Factor Receptor (EGFR) Expression, Measured by VECTRA Imaging
Baseline
|
0.54 percentage plasma EGFR
Interval 0.43 to 0.61
|
|
Plasma Membrane Epidermal Growth Factor Receptor (EGFR) Expression, Measured by VECTRA Imaging
After Treatment
|
0.40 percentage plasma EGFR
Interval 0.0 to 0.77
|
SECONDARY outcome
Timeframe: Up to 4 weeksSafety and tolerability of dasatinib in participants with operable Triple negative breast cancer (TNBC) will be based on NCI Adverse Events (AE) Version 4.0 and will be assessed by frequency tables. AEs were collected on day 1 of treatment and a minimum of 14 days after the last dose. AEs reported here were ranked as either possibly related, probably related, or definitely related to the study intervention. All AEs (including not related and unlikely related) are summarized in the AE section.
Outcome measures
| Measure |
Dasatinib 100mg
n=14 adverse events
Dasatinib 100mg for 7-10 days until day prior to surgery
Dasatinib: 100mg oral once daily dasatinib taken for 7-10 days up to the day prior to planned surgery or research biopsy (neoadjuvant chemotherapy group)
Conventional Surgery: Undergo surgery
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Number of Treatment-emergent Adverse Events [Safety and Tolerability] up to 4 Weeks
Headache
|
1 adverse events
|
|
Number of Treatment-emergent Adverse Events [Safety and Tolerability] up to 4 Weeks
Fatigue
|
4 adverse events
|
|
Number of Treatment-emergent Adverse Events [Safety and Tolerability] up to 4 Weeks
Anemia
|
2 adverse events
|
|
Number of Treatment-emergent Adverse Events [Safety and Tolerability] up to 4 Weeks
Creatinine Increase
|
1 adverse events
|
|
Number of Treatment-emergent Adverse Events [Safety and Tolerability] up to 4 Weeks
Low E-GFR
|
1 adverse events
|
|
Number of Treatment-emergent Adverse Events [Safety and Tolerability] up to 4 Weeks
Nausea
|
1 adverse events
|
|
Number of Treatment-emergent Adverse Events [Safety and Tolerability] up to 4 Weeks
Insomnia
|
1 adverse events
|
|
Number of Treatment-emergent Adverse Events [Safety and Tolerability] up to 4 Weeks
Body Aches
|
1 adverse events
|
|
Number of Treatment-emergent Adverse Events [Safety and Tolerability] up to 4 Weeks
Constipation
|
1 adverse events
|
|
Number of Treatment-emergent Adverse Events [Safety and Tolerability] up to 4 Weeks
Dyspepsia
|
1 adverse events
|
SECONDARY outcome
Timeframe: Up to 4 weeksExamine pCR rates to standard neoadjuvant chemotherapy in nuclear Epidermal Growth Factor Receptor (nEGFR) + TNBC. pCR will be defined as ypT0 ypNO (absence of cancer in breast tissue and lymph nodes) an assessed by the investigator.
Outcome measures
| Measure |
Dasatinib 100mg
n=5 Participants
Dasatinib 100mg for 7-10 days until day prior to surgery
Dasatinib: 100mg oral once daily dasatinib taken for 7-10 days up to the day prior to planned surgery or research biopsy (neoadjuvant chemotherapy group)
Conventional Surgery: Undergo surgery
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Number of Participants With Pathologic Complete Response (pCR)
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 24 monthsOutcome measures
| Measure |
Dasatinib 100mg
n=5 Participants
Dasatinib 100mg for 7-10 days until day prior to surgery
Dasatinib: 100mg oral once daily dasatinib taken for 7-10 days up to the day prior to planned surgery or research biopsy (neoadjuvant chemotherapy group)
Conventional Surgery: Undergo surgery
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Number of Participants With No Evidence of Disease (NED) at Long-term Follow up
NED at 16 months (subsequently lost to follow up)
|
1 Participants
|
|
Number of Participants With No Evidence of Disease (NED) at Long-term Follow up
NED at 24 months
|
4 Participants
|
Adverse Events
Dasatinib 100mg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dasatinib 100mg
n=5 participants at risk
Dasatinib 100mg for 7-10 days until day prior to surgery
Dasatinib: 100mg oral once daily dasatinib taken for 7-10 days up to the day prior to planned surgery or research biopsy (neoadjuvant chemotherapy group)
Conventional Surgery: Undergo surgery
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Investigations
Neutrophil Count Decreased
|
20.0%
1/5 • Number of events 1 • up to 4 weeks - see limitations and caveats
|
Other adverse events
| Measure |
Dasatinib 100mg
n=5 participants at risk
Dasatinib 100mg for 7-10 days until day prior to surgery
Dasatinib: 100mg oral once daily dasatinib taken for 7-10 days up to the day prior to planned surgery or research biopsy (neoadjuvant chemotherapy group)
Conventional Surgery: Undergo surgery
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
General disorders
Fatigue
|
80.0%
4/5 • Number of events 7 • up to 4 weeks - see limitations and caveats
|
|
Gastrointestinal disorders
Nausea
|
40.0%
2/5 • Number of events 3 • up to 4 weeks - see limitations and caveats
|
|
Gastrointestinal disorders
Constipation
|
40.0%
2/5 • Number of events 2 • up to 4 weeks - see limitations and caveats
|
|
Investigations
Creatinine Increase
|
20.0%
1/5 • Number of events 1 • up to 4 weeks - see limitations and caveats
|
|
Investigations
Low eGFR
|
20.0%
1/5 • Number of events 1 • up to 4 weeks - see limitations and caveats
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • Number of events 1 • up to 4 weeks - see limitations and caveats
|
|
General disorders
Body Aches
|
20.0%
1/5 • Number of events 1 • up to 4 weeks - see limitations and caveats
|
|
Gastrointestinal disorders
Hemorrhoids
|
20.0%
1/5 • Number of events 1 • up to 4 weeks - see limitations and caveats
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
1/5 • Number of events 1 • up to 4 weeks - see limitations and caveats
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Number of events 1 • up to 4 weeks - see limitations and caveats
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
1/5 • Number of events 2 • up to 4 weeks - see limitations and caveats
|
|
Investigations
White Blood Cell Count Decreased
|
20.0%
1/5 • Number of events 2 • up to 4 weeks - see limitations and caveats
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
1/5 • Number of events 1 • up to 4 weeks - see limitations and caveats
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
20.0%
1/5 • Number of events 1 • up to 4 weeks - see limitations and caveats
|
|
Investigations
Neutrophil count decreased
|
20.0%
1/5 • Number of events 1 • up to 4 weeks - see limitations and caveats
|
|
Investigations
Lymphocyte count decreased
|
20.0%
1/5 • Number of events 1 • up to 4 weeks - see limitations and caveats
|
|
Investigations
AST increased
|
20.0%
1/5 • Number of events 1 • up to 4 weeks - see limitations and caveats
|
|
Renal and urinary disorders
Proteinuria
|
20.0%
1/5 • Number of events 1 • up to 4 weeks - see limitations and caveats
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
20.0%
1/5 • Number of events 1 • up to 4 weeks - see limitations and caveats
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
1/5 • Number of events 1 • up to 4 weeks - see limitations and caveats
|
Additional Information
Kari Wisinski
University of Wisconsin Carbone Cancer Center
Phone: (608) 262-2876
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place