Trial Outcomes & Findings for S0622, Dasatinib in Treating Patients With Stage IV Breast Cancer That Has Spread to the Bone (NCT NCT00410813)
NCT ID: NCT00410813
Last Updated: 2017-07-02
Results Overview
RECIST progression defined as 20% increase in the sum of longest diameters of target measurable lesions over the smallest sum observed, unequivocal progression of non-measurable disease, the appearance of any new lesion/site, death due to disease without prior documentation of progression and without symptomatic deterioration, development of one or more new bone lesions from baseline, or symptomatic deterioration related to disease progression. Time from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at last date of contact.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
85 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2017-07-02
Participant Flow
Participant milestones
| Measure |
Dasatinib, 100 mg, Daily
Dasatinib, 100 mg PO daily until progression of disease
|
Dasatinib, 70 mg, Twice Daily
Dasatinib, 70 mg PO twice daily until progression of disease
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
42
|
|
Overall Study
Eligible
|
41
|
38
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
43
|
42
|
Reasons for withdrawal
| Measure |
Dasatinib, 100 mg, Daily
Dasatinib, 100 mg PO daily until progression of disease
|
Dasatinib, 70 mg, Twice Daily
Dasatinib, 70 mg PO twice daily until progression of disease
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
11
|
|
Overall Study
Progression
|
32
|
21
|
|
Overall Study
Not protocol specified
|
3
|
4
|
|
Overall Study
Ineligible
|
2
|
4
|
|
Overall Study
Death
|
0
|
2
|
Baseline Characteristics
S0622, Dasatinib in Treating Patients With Stage IV Breast Cancer That Has Spread to the Bone
Baseline characteristics by cohort
| Measure |
Dasatinib, 100 mg, Daily
n=41 Participants
Dasatinib, 100 mg PO daily until progression of disease
|
Dasatinib, 70 mg, Twice Daily
n=38 Participants
Dasatinib, 70 mg PO twice daily until progression of disease
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
65 years
n=7 Participants
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
38 participants
n=5 Participants
|
35 participants
n=7 Participants
|
73 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Use of trastuzumab at time of registration
Yes
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Use of trastuzumab at time of registration
No
|
40 participants
n=5 Participants
|
38 participants
n=7 Participants
|
78 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: All eligible patients were included in this analysis.
RECIST progression defined as 20% increase in the sum of longest diameters of target measurable lesions over the smallest sum observed, unequivocal progression of non-measurable disease, the appearance of any new lesion/site, death due to disease without prior documentation of progression and without symptomatic deterioration, development of one or more new bone lesions from baseline, or symptomatic deterioration related to disease progression. Time from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at last date of contact.
Outcome measures
| Measure |
Dasatinib, 100 mg, Daily
n=41 Participants
Dasatinib, 100 mg PO daily until progression of disease
|
Dasatinib, 70 mg, Twice Daily
n=38 Participants
Dasatinib, 70 mg PO twice daily until progression of disease
|
NTx at 8 Weeks
|
Dasatinib - Week 24
Patients received either Arm 1: Dasatinib, 100 mg, daily or Arm 2: Dasatinib, 70 mg, twice daily.
|
|---|---|---|---|---|
|
Progression-free Survival
|
10.3 weeks
Interval 8.4 to 16.7
|
15.3 weeks
Interval 8.7 to 20.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: All eligible patients
Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms, normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed, unequivocal progression of non-measurable disease, appearance of any new lesion/site, death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
Outcome measures
| Measure |
Dasatinib, 100 mg, Daily
n=41 Participants
Dasatinib, 100 mg PO daily until progression of disease
|
Dasatinib, 70 mg, Twice Daily
n=38 Participants
Dasatinib, 70 mg PO twice daily until progression of disease
|
NTx at 8 Weeks
|
Dasatinib - Week 24
Patients received either Arm 1: Dasatinib, 100 mg, daily or Arm 2: Dasatinib, 70 mg, twice daily.
|
|---|---|---|---|---|
|
Response Rate (Complete and Partial, Confirmed and Unconfirmed)
Partial Response
|
1 participants
|
0 participants
|
—
|
—
|
|
Response Rate (Complete and Partial, Confirmed and Unconfirmed)
Stable/No Response
|
14 participants
|
18 participants
|
—
|
—
|
|
Response Rate (Complete and Partial, Confirmed and Unconfirmed)
Increasing Disease
|
20 participants
|
10 participants
|
—
|
—
|
|
Response Rate (Complete and Partial, Confirmed and Unconfirmed)
Assessment Inadequate
|
6 participants
|
10 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: at 4, 8, 16, and 24 weeksPopulation: MUC-1 Inadequate Assessment, response unknown: MUC-1 response has not been adequately assessed at indicated timepoints.
MUC-1 Complete Response is reduction in MUC-1 such that MUC-1 \<= ULN. MUC-1 Partial Response is greater than or equal to a 50% reduction in MUC-1 from baseline, but not qualifying as a CR. MUC-1 Progression is greater than or equal to a 50% increase in MUC-1 from baseline. MUC-1 Stable Disease is MUC-1 response not qualifying as CR, PR, or Progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4 weeksPopulation: Treatment arms are combined in this analysis. Only eligible patients evaluated at both baseline and at 4 weeks were included. Patients analyzed for CTC response only includes patients who had elevated CTCs at baseline.
CTC response at 4 weeks is defined as the number of patients with initially elevated CTCs (\>= 5 cells/7.5 ml), whose CTC level drops to \< 5.
Outcome measures
| Measure |
Dasatinib, 100 mg, Daily
n=16 Participants
Dasatinib, 100 mg PO daily until progression of disease
|
Dasatinib, 70 mg, Twice Daily
Dasatinib, 70 mg PO twice daily until progression of disease
|
NTx at 8 Weeks
|
Dasatinib - Week 24
Patients received either Arm 1: Dasatinib, 100 mg, daily or Arm 2: Dasatinib, 70 mg, twice daily.
|
|---|---|---|---|---|
|
Circulating Tumor Cells (CTC) Response Rate
|
4 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at baseline, 4, and 8 weeksPopulation: Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.
Analysis included mean values of the serum biomarker NTx at baseline, 4, and 8 weeks.
Outcome measures
| Measure |
Dasatinib, 100 mg, Daily
n=66 Participants
Dasatinib, 100 mg PO daily until progression of disease
|
Dasatinib, 70 mg, Twice Daily
n=54 Participants
Dasatinib, 70 mg PO twice daily until progression of disease
|
NTx at 8 Weeks
n=52 Participants
|
Dasatinib - Week 24
Patients received either Arm 1: Dasatinib, 100 mg, daily or Arm 2: Dasatinib, 70 mg, twice daily.
|
|---|---|---|---|---|
|
Change in Serum Bone Turnover Markers Over Time -- NTx
|
21.84 nM BCE
Standard Deviation 12.32
|
19.23 nM BCE
Standard Deviation 11.32
|
12.88 nM BCE
Standard Deviation 13.09
|
—
|
SECONDARY outcome
Timeframe: at baseline, 4, and 8 weeksPopulation: Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.
Analysis included mean values of the serum biomarker BAP at baseline, 4, and 8 weeks.
Outcome measures
| Measure |
Dasatinib, 100 mg, Daily
n=66 Participants
Dasatinib, 100 mg PO daily until progression of disease
|
Dasatinib, 70 mg, Twice Daily
n=54 Participants
Dasatinib, 70 mg PO twice daily until progression of disease
|
NTx at 8 Weeks
n=52 Participants
|
Dasatinib - Week 24
Patients received either Arm 1: Dasatinib, 100 mg, daily or Arm 2: Dasatinib, 70 mg, twice daily.
|
|---|---|---|---|---|
|
Change in Serum Bone Turnover Markers Over Time -- BAP
|
24.07 ug/L
Standard Deviation 15.95
|
24.35 ug/L
Standard Deviation 13.94
|
25.61 ug/L
Standard Deviation 14.05
|
—
|
SECONDARY outcome
Timeframe: at baseline, 4, and 8 weeksPopulation: Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.
Analysis included mean values of the serum biomarkers sRANKL, IL-6, DKK, VEGF at baseline, 4, and 8 weeks.
Outcome measures
| Measure |
Dasatinib, 100 mg, Daily
n=66 Participants
Dasatinib, 100 mg PO daily until progression of disease
|
Dasatinib, 70 mg, Twice Daily
n=54 Participants
Dasatinib, 70 mg PO twice daily until progression of disease
|
NTx at 8 Weeks
n=52 Participants
|
Dasatinib - Week 24
Patients received either Arm 1: Dasatinib, 100 mg, daily or Arm 2: Dasatinib, 70 mg, twice daily.
|
|---|---|---|---|---|
|
Change in Serum Bone Turnover Markers Over Time
DKK
|
1157.64 pg/mL
Standard Deviation 1465.83
|
1470.50 pg/mL
Standard Deviation 1985.09
|
1575.05 pg/mL
Standard Deviation 1993.44
|
—
|
|
Change in Serum Bone Turnover Markers Over Time
IL-6
|
250.17 pg/mL
Standard Deviation 1588.17
|
19.03 pg/mL
Standard Deviation 73.70
|
32.03 pg/mL
Standard Deviation 190.36
|
—
|
|
Change in Serum Bone Turnover Markers Over Time
VEGF
|
459.01 pg/mL
Standard Deviation 324.89
|
424.21 pg/mL
Standard Deviation 355.33
|
412.33 pg/mL
Standard Deviation 346.58
|
—
|
|
Change in Serum Bone Turnover Markers Over Time
sRANKL
|
772172 pg/mL
Standard Deviation 1580514
|
531173 pg/mL
Standard Deviation 910765
|
553459 pg/mL
Standard Deviation 864151
|
—
|
SECONDARY outcome
Timeframe: at baseline, 4, and 8 weeksPopulation: Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.
Analysis included mean values of the serum biomarker OC at baseline, 4, and 8 weeks.
Outcome measures
| Measure |
Dasatinib, 100 mg, Daily
n=66 Participants
Dasatinib, 100 mg PO daily until progression of disease
|
Dasatinib, 70 mg, Twice Daily
n=54 Participants
Dasatinib, 70 mg PO twice daily until progression of disease
|
NTx at 8 Weeks
n=52 Participants
|
Dasatinib - Week 24
Patients received either Arm 1: Dasatinib, 100 mg, daily or Arm 2: Dasatinib, 70 mg, twice daily.
|
|---|---|---|---|---|
|
Change in Serum Bone Turnover Markers Over Time -- OC
|
11.08 ng/mL
Standard Deviation 7.76
|
13.10 ng/mL
Standard Deviation 9.17
|
13.54 ng/mL
Standard Deviation 10.20
|
—
|
SECONDARY outcome
Timeframe: at baseline, 4, and 8 weeksPopulation: Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.
Analysis included mean values of the serum biomarker OPG at baseline, 4, and 8 weeks.
Outcome measures
| Measure |
Dasatinib, 100 mg, Daily
n=66 Participants
Dasatinib, 100 mg PO daily until progression of disease
|
Dasatinib, 70 mg, Twice Daily
n=54 Participants
Dasatinib, 70 mg PO twice daily until progression of disease
|
NTx at 8 Weeks
n=52 Participants
|
Dasatinib - Week 24
Patients received either Arm 1: Dasatinib, 100 mg, daily or Arm 2: Dasatinib, 70 mg, twice daily.
|
|---|---|---|---|---|
|
Change in Serum Bone Turnover Markers Over Time -- OPG
|
4.56 pmol/L
Standard Deviation 5.44
|
6.53 pmol/L
Standard Deviation 9.46
|
6.71 pmol/L
Standard Deviation 10.09
|
—
|
SECONDARY outcome
Timeframe: at baseline, 4, and 8 weeksPopulation: Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.
Analysis included mean values of the serum biomarker TRAP at baseline, 4, and 8 weeks.
Outcome measures
| Measure |
Dasatinib, 100 mg, Daily
n=66 Participants
Dasatinib, 100 mg PO daily until progression of disease
|
Dasatinib, 70 mg, Twice Daily
n=54 Participants
Dasatinib, 70 mg PO twice daily until progression of disease
|
NTx at 8 Weeks
n=52 Participants
|
Dasatinib - Week 24
Patients received either Arm 1: Dasatinib, 100 mg, daily or Arm 2: Dasatinib, 70 mg, twice daily.
|
|---|---|---|---|---|
|
Change in Serum Bone Turnover Markers Over Time -- TRAP
|
6.83 U/L
Standard Deviation 6.42
|
5.41 U/L
Standard Deviation 4.23
|
5.59 U/L
Standard Deviation 4.40
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE v3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Outcome measures
| Measure |
Dasatinib, 100 mg, Daily
n=41 Participants
Dasatinib, 100 mg PO daily until progression of disease
|
Dasatinib, 70 mg, Twice Daily
n=38 Participants
Dasatinib, 70 mg PO twice daily until progression of disease
|
NTx at 8 Weeks
|
Dasatinib - Week 24
Patients received either Arm 1: Dasatinib, 100 mg, daily or Arm 2: Dasatinib, 70 mg, twice daily.
|
|---|---|---|---|---|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
ALT, SGPT (serum glutamic pyruvic transaminase)
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
AST, SGOT
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Albumin, serum-low (hypoalbuminemia)
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Anorexia
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Dehydration
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Diarrhea
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Dyspnea (shortness of breath)
|
1 Participants
|
4 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Fatigue (asthenia, lethargy, malaise)
|
0 Participants
|
6 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hemoglobin
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf w/normal ANC or Gr 1-2 neutrophils - Skin
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf w/normal ANC or Gr 1-2 neutrophils - UTI
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Infection with unknown ANC - Dental-tooth
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Left ventricular systolic dysfunction
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Lymphopenia
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Nausea
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Neutrophils/granulocytes (ANC/AGC)
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pain - Bone
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pain - Buttock
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pain - Chest wall
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pain - Chest/thorax NOS
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pain - Head/headache
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Platelets
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pleural effusion (non-malignant)
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pneumonitis/pulmonary infiltrates
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Potassium, serum-low (hypokalemia)
|
1 Participants
|
3 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pulmonary hypertension
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pulmonary/Upper Respiratory-Other (Specify)
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Rash/desquamation
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Sodium, serum-low (hyponatremia)
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Vomiting
|
0 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 8, 16, and 24 weeksPopulation: All patients with non-missing values were analyzed
Patient's rating of "worst pain" experienced between prestudy and week 24. Changes of \>=2 points on the Brief Pain Inventory (BPI) are of interest. Pain is self-reported on the Brief Pain Inventory Short Form, on a 0-10 response scale, with higher scores reflecting more pain and more interference with functioning.
Outcome measures
| Measure |
Dasatinib, 100 mg, Daily
n=79 Participants
Dasatinib, 100 mg PO daily until progression of disease
|
Dasatinib, 70 mg, Twice Daily
n=68 Participants
Dasatinib, 70 mg PO twice daily until progression of disease
|
NTx at 8 Weeks
n=37 Participants
|
Dasatinib - Week 24
n=41 Participants
Patients received either Arm 1: Dasatinib, 100 mg, daily or Arm 2: Dasatinib, 70 mg, twice daily.
|
|---|---|---|---|---|
|
Mean Patient-reported Pain
|
3.37 units on a scale
Standard Deviation 2.93
|
3.82 units on a scale
Standard Deviation 3.04
|
3.06 units on a scale
Standard Deviation 2.61
|
3.73 units on a scale
Standard Deviation 3.03
|
Adverse Events
Dasatinib, 100 mg, Daily
Serious events: 6 serious events
Other events: 34 other events
Deaths: 0 deaths
Dasatinib, 70 mg, Twice Daily
Serious events: 12 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dasatinib, 100 mg, Daily
n=41 participants at risk
Dasatinib, 100 mg PO daily until progression of disease
|
Dasatinib, 70 mg, Twice Daily
n=38 participants at risk
Dasatinib, 70 mg PO twice daily until progression of disease
|
|---|---|---|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/41 • Up to 2 years
|
2.6%
1/38 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/41 • Up to 2 years
|
2.6%
1/38 • Up to 2 years
|
|
General disorders
Death not associated with CTCAE term - Death NOS
|
0.00%
0/41 • Up to 2 years
|
2.6%
1/38 • Up to 2 years
|
|
General disorders
Sudden death
|
0.00%
0/41 • Up to 2 years
|
2.6%
1/38 • Up to 2 years
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Skin
|
0.00%
0/41 • Up to 2 years
|
2.6%
1/38 • Up to 2 years
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - UTI
|
2.4%
1/41 • Up to 2 years
|
2.6%
1/38 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Rash: dermatitis associated w/Chemoradiation
|
0.00%
0/41 • Up to 2 years
|
2.6%
1/38 • Up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/41 • Up to 2 years
|
2.6%
1/38 • Up to 2 years
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
0.00%
0/41 • Up to 2 years
|
2.6%
1/38 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
0.00%
0/41 • Up to 2 years
|
2.6%
1/38 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
2.4%
1/41 • Up to 2 years
|
0.00%
0/38 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
2.4%
1/41 • Up to 2 years
|
0.00%
0/38 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death - Disease progression NOS
|
2.4%
1/41 • Up to 2 years
|
0.00%
0/38 • Up to 2 years
|
|
Renal and urinary disorders
Renal failure
|
2.4%
1/41 • Up to 2 years
|
0.00%
0/38 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/41 • Up to 2 years
|
2.6%
1/38 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
2.4%
1/41 • Up to 2 years
|
5.3%
2/38 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
4.9%
2/41 • Up to 2 years
|
0.00%
0/38 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other (Specify)
|
0.00%
0/41 • Up to 2 years
|
2.6%
1/38 • Up to 2 years
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/41 • Up to 2 years
|
2.6%
1/38 • Up to 2 years
|
Other adverse events
| Measure |
Dasatinib, 100 mg, Daily
n=41 participants at risk
Dasatinib, 100 mg PO daily until progression of disease
|
Dasatinib, 70 mg, Twice Daily
n=38 participants at risk
Dasatinib, 70 mg PO twice daily until progression of disease
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
39.0%
16/41 • Up to 2 years
|
57.9%
22/38 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
19.5%
8/41 • Up to 2 years
|
7.9%
3/38 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
24.4%
10/41 • Up to 2 years
|
36.8%
14/38 • Up to 2 years
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
2.4%
1/41 • Up to 2 years
|
5.3%
2/38 • Up to 2 years
|
|
Gastrointestinal disorders
Flatulence
|
7.3%
3/41 • Up to 2 years
|
5.3%
2/38 • Up to 2 years
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
9.8%
4/41 • Up to 2 years
|
2.6%
1/38 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
36.6%
15/41 • Up to 2 years
|
50.0%
19/38 • Up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
24.4%
10/41 • Up to 2 years
|
21.1%
8/38 • Up to 2 years
|
|
General disorders
Edema: head and neck
|
2.4%
1/41 • Up to 2 years
|
7.9%
3/38 • Up to 2 years
|
|
General disorders
Edema: limb
|
4.9%
2/41 • Up to 2 years
|
15.8%
6/38 • Up to 2 years
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
46.3%
19/41 • Up to 2 years
|
50.0%
19/38 • Up to 2 years
|
|
General disorders
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
7.3%
3/41 • Up to 2 years
|
5.3%
2/38 • Up to 2 years
|
|
General disorders
Pain - Chest/thorax NOS
|
4.9%
2/41 • Up to 2 years
|
5.3%
2/38 • Up to 2 years
|
|
General disorders
Pain-Other (Specify)
|
12.2%
5/41 • Up to 2 years
|
13.2%
5/38 • Up to 2 years
|
|
General disorders
Rigors/chills
|
2.4%
1/41 • Up to 2 years
|
5.3%
2/38 • Up to 2 years
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Skin
|
7.3%
3/41 • Up to 2 years
|
0.00%
0/38 • Up to 2 years
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
17.1%
7/41 • Up to 2 years
|
31.6%
12/38 • Up to 2 years
|
|
Investigations
AST, SGOT
|
24.4%
10/41 • Up to 2 years
|
42.1%
16/38 • Up to 2 years
|
|
Investigations
Alkaline phosphatase
|
14.6%
6/41 • Up to 2 years
|
23.7%
9/38 • Up to 2 years
|
|
Investigations
Creatinine
|
12.2%
5/41 • Up to 2 years
|
15.8%
6/38 • Up to 2 years
|
|
Investigations
Leukocytes (total WBC)
|
17.1%
7/41 • Up to 2 years
|
18.4%
7/38 • Up to 2 years
|
|
Investigations
Lymphopenia
|
4.9%
2/41 • Up to 2 years
|
7.9%
3/38 • Up to 2 years
|
|
Investigations
Metabolic/Laboratory-Other (Specify)
|
0.00%
0/41 • Up to 2 years
|
5.3%
2/38 • Up to 2 years
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
7.3%
3/41 • Up to 2 years
|
10.5%
4/38 • Up to 2 years
|
|
Investigations
Platelets
|
9.8%
4/41 • Up to 2 years
|
13.2%
5/38 • Up to 2 years
|
|
Investigations
Weight loss
|
4.9%
2/41 • Up to 2 years
|
15.8%
6/38 • Up to 2 years
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
0.00%
0/41 • Up to 2 years
|
15.8%
6/38 • Up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
19.5%
8/41 • Up to 2 years
|
23.7%
9/38 • Up to 2 years
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
9.8%
4/41 • Up to 2 years
|
18.4%
7/38 • Up to 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/41 • Up to 2 years
|
5.3%
2/38 • Up to 2 years
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
26.8%
11/41 • Up to 2 years
|
23.7%
9/38 • Up to 2 years
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
9.8%
4/41 • Up to 2 years
|
13.2%
5/38 • Up to 2 years
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
9.8%
4/41 • Up to 2 years
|
23.7%
9/38 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
29.3%
12/41 • Up to 2 years
|
10.5%
4/38 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
17.1%
7/41 • Up to 2 years
|
26.3%
10/38 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
9.8%
4/41 • Up to 2 years
|
10.5%
4/38 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
9.8%
4/41 • Up to 2 years
|
7.9%
3/38 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
7.3%
3/41 • Up to 2 years
|
7.9%
3/38 • Up to 2 years
|
|
Nervous system disorders
Dizziness
|
9.8%
4/41 • Up to 2 years
|
2.6%
1/38 • Up to 2 years
|
|
Nervous system disorders
Neuropathy: sensory
|
14.6%
6/41 • Up to 2 years
|
7.9%
3/38 • Up to 2 years
|
|
Nervous system disorders
Pain - Head/headache
|
26.8%
11/41 • Up to 2 years
|
23.7%
9/38 • Up to 2 years
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
4.9%
2/41 • Up to 2 years
|
10.5%
4/38 • Up to 2 years
|
|
Nervous system disorders
Tremor
|
0.00%
0/41 • Up to 2 years
|
5.3%
2/38 • Up to 2 years
|
|
Psychiatric disorders
Insomnia
|
17.1%
7/41 • Up to 2 years
|
10.5%
4/38 • Up to 2 years
|
|
Psychiatric disorders
Mood alteration - anxiety
|
14.6%
6/41 • Up to 2 years
|
10.5%
4/38 • Up to 2 years
|
|
Psychiatric disorders
Mood alteration - depression
|
7.3%
3/41 • Up to 2 years
|
2.6%
1/38 • Up to 2 years
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
2.4%
1/41 • Up to 2 years
|
5.3%
2/38 • Up to 2 years
|
|
Renal and urinary disorders
Urine color change
|
0.00%
0/41 • Up to 2 years
|
5.3%
2/38 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
7.3%
3/41 • Up to 2 years
|
2.6%
1/38 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.5%
8/41 • Up to 2 years
|
21.1%
8/38 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
17.1%
7/41 • Up to 2 years
|
31.6%
12/38 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
17.1%
7/41 • Up to 2 years
|
7.9%
3/38 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)
|
0.00%
0/41 • Up to 2 years
|
5.3%
2/38 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
2.4%
1/41 • Up to 2 years
|
5.3%
2/38 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
0.00%
0/41 • Up to 2 years
|
10.5%
4/38 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
12.2%
5/41 • Up to 2 years
|
15.8%
6/38 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
7.3%
3/41 • Up to 2 years
|
15.8%
6/38 • Up to 2 years
|
|
Vascular disorders
Hot flashes/flushes
|
7.3%
3/41 • Up to 2 years
|
7.9%
3/38 • Up to 2 years
|
Additional Information
SWOG Breast Committee Statistician
SWOG Statistical Center
Phone: 206-667-4623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60