Trial Outcomes & Findings for Phase II Short-term Adjuvant Therapy and Biomarker Studies With Targeted Agents in Women With Estrogen Receptor Negative Breast Cancer (NCT NCT01471106)
NCT ID: NCT01471106
Last Updated: 2024-07-10
Results Overview
Change in Ki-67 measured in baseline and month 3 using contralateral breast Fine Needle Aspiration (FNA) samples. Samples evaluated by immunohistochemistry (IHC). Baseline and follow up Ki-67 values presented in percentage (%) of cell positive, change reflects difference in percentage. Ki-67 is measured as a continuous variable and a one-way ANOVA followed by Dunnett's multiple comparison test comparing the change of Ki-67 of each of the three treated groups with control.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
up to 3 months
Results posted on
2024-07-10
Participant Flow
26 patients were enrolled by 08/13/2018, of which were 24 randomized, 6 in No Treatment/Control, 12 in Dasatinib 40 mg, and 6 in Dasatinib 80 mg.
Participant milestones
| Measure |
Group 1: Dasatinib 40 mg
Dasatinib 40 mg by mouth once a day for 3 months (+/- 7 days), At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.
Dasatinib: Group 1: 40 mg by mouth once a day.
Dasatinib Group 2: 80 mg by mouth once a day.
|
Group 2: Dasatinib 80 mg
Dasatinib 80 mg by mouth once a day for 3 months (+/- 7 days). At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.
Dasatinib: Group 1: 40 mg by mouth once a day.
Dasatinib Group 2: 80 mg by mouth once a day.
|
Group 3: No Dasatinib
No treatment control group. At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
6
|
6
|
|
Overall Study
COMPLETED
|
12
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Short-term Adjuvant Therapy and Biomarker Studies With Targeted Agents in Women With Estrogen Receptor Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Group 1: Dasatinib 40 mg
n=12 Participants
Dasatinib 40 mg by mouth once a day for 3 months (+/- 7 days), At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.
Dasatinib: Group 1: 40 mg by mouth once a day.
Dasatinib Group 2: 80 mg by mouth once a day.
|
Group 2: Dasatinib 80 mg
n=6 Participants
Dasatinib 80 mg by mouth once a day for 3 months (+/- 7 days). At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.
Dasatinib: Group 1: 40 mg by mouth once a day.
Dasatinib Group 2: 80 mg by mouth once a day.
|
Group 3: No Dasatinib
n=6 Participants
No treatment control group. At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Continuous
|
62.4 Years
n=5 Participants
|
50.8 Years
n=7 Participants
|
54 Years
n=5 Participants
|
56.8 Years
n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
24 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: up to 3 monthsPopulation: FNA yield for matched pre-and-post treatment FNA samples was technically insufficient for Ki-67 immunohistochemitry analysis
Change in Ki-67 measured in baseline and month 3 using contralateral breast Fine Needle Aspiration (FNA) samples. Samples evaluated by immunohistochemistry (IHC). Baseline and follow up Ki-67 values presented in percentage (%) of cell positive, change reflects difference in percentage. Ki-67 is measured as a continuous variable and a one-way ANOVA followed by Dunnett's multiple comparison test comparing the change of Ki-67 of each of the three treated groups with control.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 3 monthsEvaluation of serum utilizing ELISA kits for IGFBP1
Outcome measures
| Measure |
Group 1: Dasatinib 40 mg
n=12 Participants
Dasatinib 40 mg by mouth once a day for 3 months (+/- 7 days), At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.
Dasatinib: Group 1: 40 mg by mouth once a day.
Dasatinib Group 2: 80 mg by mouth once a day.
|
Group 2: Dasatinib 80 mg
n=6 Participants
Dasatinib 80 mg by mouth once a day for 3 months (+/- 7 days). At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.
Dasatinib: Group 1: 40 mg by mouth once a day.
Dasatinib Group 2: 80 mg by mouth once a day.
|
Group 3: No Dasatinib
n=6 Participants
No treatment control group. At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.
|
|---|---|---|---|
|
To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway
Pre-treatment
|
6683 pg/ml
Standard Deviation 4086.6
|
2320.9 pg/ml
Standard Deviation 797.1
|
6524 pg/ml
Standard Deviation 3900.3
|
|
To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway
Post-treatment
|
8508.5 pg/ml
Standard Deviation 7992.3
|
4270.6 pg/ml
Standard Deviation 4405.3
|
7270.1 pg/ml
Standard Deviation 4715.4
|
SECONDARY outcome
Timeframe: up to 3 monthsEvaluation of serum utilizing ELISA kits for IGF1
Outcome measures
| Measure |
Group 1: Dasatinib 40 mg
n=12 Participants
Dasatinib 40 mg by mouth once a day for 3 months (+/- 7 days), At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.
Dasatinib: Group 1: 40 mg by mouth once a day.
Dasatinib Group 2: 80 mg by mouth once a day.
|
Group 2: Dasatinib 80 mg
n=6 Participants
Dasatinib 80 mg by mouth once a day for 3 months (+/- 7 days). At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.
Dasatinib: Group 1: 40 mg by mouth once a day.
Dasatinib Group 2: 80 mg by mouth once a day.
|
Group 3: No Dasatinib
n=6 Participants
No treatment control group. At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.
|
|---|---|---|---|
|
To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway
Pre-treatment
|
71.8 ng/ml
Standard Deviation 35.6
|
79.8 ng/ml
Standard Deviation 22.3
|
95.2 ng/ml
Standard Deviation 25.7
|
|
To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway
Post-treatment
|
70.3 ng/ml
Standard Deviation 41
|
68.2 ng/ml
Standard Deviation 24.4
|
95.3 ng/ml
Standard Deviation 27.7
|
SECONDARY outcome
Timeframe: up to 3 monthsEvaluation of serum utilizing ELISA kits for IGFBP3
Outcome measures
| Measure |
Group 1: Dasatinib 40 mg
n=12 Participants
Dasatinib 40 mg by mouth once a day for 3 months (+/- 7 days), At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.
Dasatinib: Group 1: 40 mg by mouth once a day.
Dasatinib Group 2: 80 mg by mouth once a day.
|
Group 2: Dasatinib 80 mg
n=6 Participants
Dasatinib 80 mg by mouth once a day for 3 months (+/- 7 days). At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.
Dasatinib: Group 1: 40 mg by mouth once a day.
Dasatinib Group 2: 80 mg by mouth once a day.
|
Group 3: No Dasatinib
n=6 Participants
No treatment control group. At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.
|
|---|---|---|---|
|
To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway
pretreatment
|
2041 ng/ml
Standard Deviation 411.1
|
1999 ng/ml
Standard Deviation 136.7
|
2279.9 ng/ml
Standard Deviation 394.5
|
|
To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway
Post-treatment
|
2027.6 ng/ml
Standard Deviation 348.9
|
2048.4 ng/ml
Standard Deviation 220.7
|
2080.2 ng/ml
Standard Deviation 514.4
|
Adverse Events
Group 1: Dasatinib 40 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Group 2: Dasatinib 80 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 3: No Dasatinib
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: Dasatinib 40 mg
n=12 participants at risk
Dasatinib 40 mg by mouth once a day for 3 months (+/- 7 days), At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.
Dasatinib: Group 1: 40 mg by mouth once a day.
Dasatinib Group 2: 80 mg by mouth once a day.
|
Group 2: Dasatinib 80 mg
n=6 participants at risk
Dasatinib 80 mg by mouth once a day for 3 months (+/- 7 days). At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.
Dasatinib: Group 1: 40 mg by mouth once a day.
Dasatinib Group 2: 80 mg by mouth once a day.
|
Group 3: No Dasatinib
n=6 participants at risk
No treatment control group. At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.3%
1/12 • Number of events 1 • Up to 3 months
|
16.7%
1/6 • Number of events 1 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • Number of events 1 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
1/12 • Number of events 1 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • Up to 3 months
|
16.7%
1/6 • Number of events 1 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Number of events 1 • Up to 3 months
|
16.7%
1/6 • Number of events 1 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • Number of events 1 • Up to 3 months
|
33.3%
2/6 • Number of events 2 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Number of events 1 • Up to 3 months
|
16.7%
1/6 • Number of events 1 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
|
Nervous system disorders
Dysgeusia
|
8.3%
1/12 • Number of events 1 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
|
General disorders
Fatigue
|
41.7%
5/12 • Number of events 5 • Up to 3 months
|
33.3%
2/6 • Number of events 2 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
|
General disorders
Fever
|
0.00%
0/12 • Up to 3 months
|
16.7%
1/6 • Number of events 1 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
|
Injury, poisoning and procedural complications
Fracture
|
8.3%
1/12 • Number of events 1 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/12 • Up to 3 months
|
16.7%
1/6 • Number of events 1 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - (Other), specify
|
25.0%
3/12 • Number of events 3 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
|
Nervous system disorders
Headache
|
41.7%
5/12 • Number of events 5 • Up to 3 months
|
33.3%
2/6 • Number of events 2 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
|
Vascular disorders
Hot flashes
|
8.3%
1/12 • Number of events 1 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
|
Infections and infestations
Infections and infestations - (Other), specify
|
0.00%
0/12 • Up to 3 months
|
16.7%
1/6 • Number of events 1 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Specify (Other)
|
8.3%
1/12 • Number of events 1 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12 • Number of events 2 • Up to 3 months
|
33.3%
2/6 • Number of events 2 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
|
General disorders
Pain
|
8.3%
1/12 • Number of events 1 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • Up to 3 months
|
16.7%
1/6 • Number of events 1 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/12 • Up to 3 months
|
16.7%
1/6 • Number of events 1 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
2/12 • Number of events 3 • Up to 3 months
|
16.7%
1/6 • Number of events 1 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/12 • Up to 3 months
|
16.7%
1/6 • Number of events 1 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.3%
1/12 • Number of events 1 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
|
Renal and urinary disorders
Renal and urinary disorders - (Other), specify
|
0.00%
0/12 • Up to 3 months
|
16.7%
1/6 • Number of events 1 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place