Trial Outcomes & Findings for Safety and Efficacy of Exemestane Plus Dasatinib Versus Placebo for Advanced ER+ Breast Cancer (NCT NCT00767520)
NCT ID: NCT00767520
Last Updated: 2013-02-28
Results Overview
PFS= The time (weeks) from date of randomization to date of progressive disease(PD). PFS for each randomization arm was estimated using the Kaplan-Meier product-limit method. A point estimate and a 95% confidence interval (CI) for the median PFS was computed for each randomization arm using the Brookmeyer \& Crowley method. PD=Increase (≥ 20%) in sum of longest diameters from smallest value during study (including baseline).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
155 participants
Primary outcome timeframe
Prior to study therapy, at 8 week intervals until progression occurs (maximum participant PFS of 71 weeks)
Results posted on
2013-02-28
Participant Flow
Participant milestones
| Measure |
Exemestane + Dasatinib
Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
|
Exemestane + Placebo
Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
|
|---|---|---|
|
Overall Study
STARTED
|
79
|
78
|
|
Overall Study
COMPLETED
|
68
|
61
|
|
Overall Study
NOT COMPLETED
|
11
|
17
|
Reasons for withdrawal
| Measure |
Exemestane + Dasatinib
Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
|
Exemestane + Placebo
Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
|
|---|---|---|
|
Overall Study
Participants still on treatment
|
11
|
15
|
|
Overall Study
Randomized in error and Never treated
|
0
|
2
|
Baseline Characteristics
Safety and Efficacy of Exemestane Plus Dasatinib Versus Placebo for Advanced ER+ Breast Cancer
Baseline characteristics by cohort
| Measure |
Exemestane + Dasatinib
n=79 Participants
Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
|
Exemestane + Placebo
n=78 Participants
Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
63.2 Years
STANDARD_DEVIATION 12.19 • n=5 Participants
|
60.1 Years
STANDARD_DEVIATION 10.43 • n=7 Participants
|
61.7 Years
STANDARD_DEVIATION 11.41 • n=5 Participants
|
|
Age, Customized
< 50 years
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Age, Customized
>=50 years
|
69 participants
n=5 Participants
|
68 participants
n=7 Participants
|
137 participants
n=5 Participants
|
|
Age, Customized
Not reported
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
68 participants
n=5 Participants
|
58 participants
n=7 Participants
|
126 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
11 participants
n=5 Participants
|
19 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic / Latino
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic / Not Latino
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
69 participants
n=5 Participants
|
70 participants
n=7 Participants
|
139 participants
n=5 Participants
|
|
Time from Initial diagnosis to randomization
|
97.63 months
STANDARD_DEVIATION 74.866 • n=5 Participants
|
87.09 months
STANDARD_DEVIATION 64.743 • n=7 Participants
|
92.46 months
STANDARD_DEVIATION 70.058 • n=5 Participants
|
|
Setting of Non-steroidal Aromatase Inhibitor
Adjuvant
|
27 participants
n=5 Participants
|
27 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Setting of Non-steroidal Aromatase Inhibitor
Advanced
|
52 participants
n=5 Participants
|
51 participants
n=7 Participants
|
103 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
0=normal activity
|
46 participants
n=5 Participants
|
46 participants
n=7 Participants
|
92 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
1=symptoms, but fully ambulatory
|
32 participants
n=5 Participants
|
30 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Not reported
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Symptomatic Bone Disease
No
|
48 participants
n=5 Participants
|
46 participants
n=7 Participants
|
94 participants
n=5 Participants
|
|
Symptomatic Bone Disease
Yes
|
31 participants
n=5 Participants
|
32 participants
n=7 Participants
|
63 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Prior to study therapy, at 8 week intervals until progression occurs (maximum participant PFS of 71 weeks)Population: All randomized participants. Participants who died without reporting tumor progression were considered to have progressed on the death date. Participants who neither progressed nor died were censored on the day of their last on-study tumor assessment or the first date of subsequent therapy.
PFS= The time (weeks) from date of randomization to date of progressive disease(PD). PFS for each randomization arm was estimated using the Kaplan-Meier product-limit method. A point estimate and a 95% confidence interval (CI) for the median PFS was computed for each randomization arm using the Brookmeyer \& Crowley method. PD=Increase (≥ 20%) in sum of longest diameters from smallest value during study (including baseline).
Outcome measures
| Measure |
Exemestane + Dasatinib
n=79 Participants
Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
|
Exemestane + Placebo
n=78 Participants
Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
|
|---|---|---|
|
Progression Free Survival (PFS) Distribution for Exemestane Plus Dasatinib vs Exemestane Plus Placebo
|
18.1 weeks
Interval 15.1 to 24.3
|
16.1 weeks
Interval 12.1 to 18.1
|
PRIMARY outcome
Timeframe: Prior to study therapy, at 8 week intervals until progression occurs. Maximum participant PFS of ____ months)Population: All randomized participants. Participants who died without reporting tumor progression were considered to have progressed on the death date. Participants who neither progressed nor died were censored on the day of their last on-study tumor assessment or the first date of subsequent therapy.
PD is an increase (≥ 20%) in sum of longest diameters from smallest value during study (including baseline).
Outcome measures
| Measure |
Exemestane + Dasatinib
n=79 Participants
Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
|
Exemestane + Placebo
n=78 Participants
Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
|
|---|---|---|
|
Participants With Disease Progression or Death for Exemestane Plus Dasatinib vs Exemestane Plus Placebo
Censored
|
19 participants
|
19 participants
|
|
Participants With Disease Progression or Death for Exemestane Plus Dasatinib vs Exemestane Plus Placebo
Disease Progression
|
56 participants
|
59 participants
|
|
Participants With Disease Progression or Death for Exemestane Plus Dasatinib vs Exemestane Plus Placebo
Death
|
4 participants
|
0 participants
|
SECONDARY outcome
Timeframe: at 6 monthsPopulation: Response-evaluable participants: All treated participants who had measurable disease at baseline and at least one on-study tumor assessment. Treated participants without on-study tumor assessment due to rapid progression or study drug toxicity were included in the response-evaluable population as non-responders.
Complete response (CR) = Disappearance of all measurable and non-measurable lesions, and no new lesions; Partial response (PR) = Decrease ≥30% from baseline in sum of longest diameters (LD) of all measurable lesions, with neither appearance of new lesions nor unequivocal progression of non-measurable lesions. SD = Disease re-assessment not qualifying as CR, PR or PD(≥20% increase in sum of longest diameters from smallest value).
Outcome measures
| Measure |
Exemestane + Dasatinib
n=49 Participants
Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
|
Exemestane + Placebo
n=49 Participants
Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
|
|---|---|---|
|
Number of Participants With Best Overall Response
Not reported
|
8 participants
|
11 participants
|
|
Number of Participants With Best Overall Response
Complete response (CR)
|
0 participants
|
0 participants
|
|
Number of Participants With Best Overall Response
Partial response (PR)
|
3 participants
|
0 participants
|
|
Number of Participants With Best Overall Response
Stable Disease (SD)
|
21 participants
|
14 participants
|
|
Number of Participants With Best Overall Response
Disease Progression
|
15 participants
|
23 participants
|
|
Number of Participants With Best Overall Response
Unable to assess
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: at 6 monthsPopulation: Response-evaluable participants: All treated participants who had measurable disease at baseline and at least one on-study tumor assessment. Treated participants without on-study tumor assessment due to rapid progression or study drug toxicity were included in the response-evaluable population as non-responders.
CB = participants whose best response is CR, PR, or stable disease(SD). CR = Disappearance of all measurable and non-measurable lesions, and no new lesions; PR = Decrease ≥30% from baseline in sum of longest diameters of all measurable lesions, with neither appearance of new lesions nor unequivocal progression of non-measurable lesions. SD = Disease re-assessment not qualifying as CR, PR or PD(≥20% increase in sum of longest diameters from smallest value). Confidence interval computed by Clopper-Pearson method.
Outcome measures
| Measure |
Exemestane + Dasatinib
n=49 Participants
Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
|
Exemestane + Placebo
n=49 Participants
Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
|
|---|---|---|
|
Percentage of Participants With Clinical Benefit (CB) for Exemestane Plus Dasatinib Arm vs Exemestane Plus Placebo Arm at 6 Months
|
30.61 percentage of participants
Interval 18.25 to 45.42
|
12.24 percentage of participants
Interval 4.63 to 24.77
|
SECONDARY outcome
Timeframe: Prior to study therapy, at 8 week intervals until progression occurs (maximum participant response was 39 weeks)Population: Response-evaluable participants: All treated participants who had measurable disease at baseline and at least one on-study tumor assessment. Treated participants without on-study tumor assessment due to rapid progression or study drug toxicity were included in the response-evaluable population as non-responders.
Response= Proportion of response-evaluable participants whose best response is CR or PR. Confidence intervals was computed using the Clopper-Pearson method. CR = Disappearance of all measurable and non-measurable lesions, and no new lesions; PR = Decrease ≥30% from baseline in sum of longest diameters of all measurable lesions, with neither appearance of new lesions nor unequivocal progression of non-measurable lesions.
Outcome measures
| Measure |
Exemestane + Dasatinib
n=49 Participants
Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
|
Exemestane + Placebo
n=49 Participants
Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
|
|---|---|---|
|
Percentage of Participants With Response in Exemestane Plus Dasatinib Arm and Exemestane Plus Placebo Arms
|
6.12 percentage of participants
Interval 1.28 to 16.87
|
0 percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: at 6 monthsFFP at month 6 is defined for the randomized participants who had the probability of neither progressing nor dying before 6 months.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Prior to study therapy, at 8 week intervals until CR or PR. Participants will remain on study (ie, last visit) until disease progression or 30 days after the last dose of study drug, whichever is longerTime to response is defined as time from first dose of study therapy until measurement criteria are first met for PR or CR (whichever is recorded first). CR = Disappearance of all measurable and non-measurable lesions, and no new lesions; PR = Decrease ≥30% from baseline in sum of longest diameters of all measurable lesions, with neither appearance of new lesions nor unequivocal progression of non-measurable lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Prior to study therapy, at 8 week intervals. Participants will remain on study (ie, last visit) until disease progression or 30 days after the last dose of study drug, whichever is longer.Duration of response is defined as the time from date that measurement criteria are first met for PR or CR until first date of documented PD or death. CR = Disappearance of all measurable and non-measurable lesions, and no new lesions; PR = Decrease ≥30% from baseline in sum of longest diameters of all measurable lesions, with neither appearance of new lesions nor unequivocal progression of non-measurable lesions. PD=Increase (≥ 20%) in sum of longest diameters from smallest value during study (including baseline).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of study, at treatment start, after 2, 4, and 8 weeks of therapy and every 8 weeks thereafter, at end-of-treatment. Participants will remain on study (ie, last visit) until disease progression or 30 days after the last dose of study drug.Pain intensity evaluated by administration of the Brief Pain Inventory - Short Form (BPI-sf). The BPI-sf is a psychometrically-validated instrument which measures both pain severity and functional interference caused by pain using an 11-point numerical rating scale. Severity of pain at its "worst", "least" and "on average" in the last 24 hours, and "right now" (ie, at the time the questionnaire is being filled out) is recorded using anchors of "no pain" = "0" and "pain as bad as you can imagine" = "10".
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening, Day 1, after week 2, 4, and week 8 and subsequently every 8 weeks, at end-of-treatment. Participants will remain on study (ie, last visit) until disease progression or 30 days after the last dose of study drug.Assay for urinary N-telopeptide was used to evaluate Osteolytic activity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of study drug therapy up to 30 days after the last dose. Median duration of therapy (on-study time) was 14.29 and 15.29 weeks for dasatinib and placebo groups, respectively.Population: All treated participants.
AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded. Grade (GR)1 = mild, GR 2 = moderate, GR 3=severe, GR 4=life threatening, GR 5=death.
Outcome measures
| Measure |
Exemestane + Dasatinib
n=79 Participants
Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
|
Exemestane + Placebo
n=76 Participants
Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
|
|---|---|---|
|
Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs (as Per National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 3.0)
All Deaths
|
10 participants
|
2 participants
|
|
Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs (as Per National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 3.0)
All SAEs
|
22 participants
|
13 participants
|
|
Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs (as Per National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 3.0)
Drug-related SAEs
|
10 participants
|
4 participants
|
|
Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs (as Per National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 3.0)
AEs leading to discontinuation
|
20 participants
|
6 participants
|
|
Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs (as Per National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 3.0)
All AEs
|
77 participants
|
67 participants
|
|
Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs (as Per National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 3.0)
Drug-related AEs
|
70 participants
|
48 participants
|
|
Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs (as Per National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 3.0)
Drug-related Grade 3/4 AEs
|
26 participants
|
8 participants
|
|
Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs (as Per National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 3.0)
Drug-related Grade 5 AEs
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment. Median duration (on-study) was 14.29 and 15.29 weeks for dasatinib and placebo groups, respectively.Population: All treated participants.
Abnormalities were graded per NCI-CTC, Version 3.0 criteria. Grade (GR)1 = mild, GR 2 = moderate, GR 3 = severe, GR 4 = life threatening. Normal ranges are provided by the Local Laboratory and may vary according to sex and age. Granulocytes, GR 1;\<LLN-1.5x 10\^9/L, GR 2:\<1.5-1.0x10\^9/L, GR 3: \<1.0 - 0.5x10\^9/L, GR, 4: \<0.5x10\^9 /L; Hemoglobin, GR 1: \<LLN-10.0 g/dL, GR 2: \<10.0-8.0 g/dL, GR 3: \<8.0-6.5 g/dL, GR, 4: \<6.5g/dL; Platelets, GR 1: \<LLN-75.0x10\^9/L, GR 2: \<75.0-50.0x10\^9/L, GR 3: \<50.0-25.0x10\^9/L; Leukocytes, GR 1: \<LLN-3.0x10\^9/L, GR 2: \<3.0-2.0x10\^9/L, GR 4: \<1.0x10\^9/L.
Outcome measures
| Measure |
Exemestane + Dasatinib
n=79 Participants
Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
|
Exemestane + Placebo
n=76 Participants
Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
|
|---|---|---|
|
Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0)
Granulocytes; Grade 1
|
18 participants
|
9 participants
|
|
Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0)
Granulocytes; Grade 2
|
10 participants
|
1 participants
|
|
Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0)
Granulocytes; Grade 3
|
2 participants
|
0 participants
|
|
Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0)
Granulocytes; Grade 4
|
0 participants
|
2 participants
|
|
Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0)
Granulocytes; Grade Not reported
|
2 participants
|
0 participants
|
|
Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0)
Hemoglobin; Grade 1
|
42 participants
|
21 participants
|
|
Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0)
Hemoglobin; Grade 2
|
11 participants
|
6 participants
|
|
Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0)
Hemoglobin; Grade 3
|
1 participants
|
2 participants
|
|
Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0)
Hemoglobin; Grade 4
|
1 participants
|
2 participants
|
|
Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0)
Hemoglobin; Grade Not reported
|
2 participants
|
0 participants
|
|
Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0)
Platelet Count; Grade 1
|
10 participants
|
2 participants
|
|
Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0)
Platelet Count; Grade 2
|
2 participants
|
1 participants
|
|
Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0)
Platelet Count; Grade 3
|
0 participants
|
1 participants
|
|
Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0)
Platelet Count; Grade Not reported
|
2 participants
|
0 participants
|
|
Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0)
Leukocytes; Grade 1
|
23 participants
|
12 participants
|
|
Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0)
Leukocytes; Grade 2
|
7 participants
|
2 participants
|
|
Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0)
Leukocytes; Grade 4
|
0 participants
|
1 participants
|
|
Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0)
Leukocytes; Grade Not reported
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment. Median duration (on-study time) was 14.29 and 15.29 weeks for dasatinib and placebo groups, respectively.Population: All treated participants.
Grade (GR) 1 = mild, GR 2 = moderate, GR 3 = severe, GR 4 = life threatening). Normal ranges are provided by the Local Laboratory and may vary according to sex and age. Alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase, GR 1: \>ULN-2.5 x ULN (upper limit of normal), GR 2: \>2.5-5.0 x ULN, GR 3: 5.0-20.0 x ULN; Low calcium, GR 1: \<LLN - 8.0 mg/dL, GR 2: \<8.0-7.0 mg/dL, GR 4:\<6.0 mg/dL; High calcium, GR 1:\>ULN - 11.5 mg/dL; bilirubin, GR 1: \>ULN-1.5 x ULN,GR 3: \>3-10 x ULN; Creatinine, GR1:\>ULN-1.5 x ULN, GR2: \>1.5-3.0 x ULN; Albumin, GR1:\<LLN-3 g/dL,GR2:\<3-2 g/dL.
Outcome measures
| Measure |
Exemestane + Dasatinib
n=79 Participants
Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
|
Exemestane + Placebo
n=76 Participants
Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
|
|---|---|---|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)
Alkaline Phosphatase; Grade 1
|
20 participants
|
15 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)
Alkaline Phosphatase; Grade 2
|
3 participants
|
10 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)
Alkaline Phosphatase; Grade 3
|
2 participants
|
0 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)
Alkaline Phosphatase; Grade Not reported
|
2 participants
|
0 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)
Alanine Aminotransferase; Grade 1
|
38 participants
|
16 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)
Alanine Aminotransferase; Grade 2
|
4 participants
|
3 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)
Alanine Aminotransferase; Grade 3
|
0 participants
|
3 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)
Alanine Aminotransferase; Grade Not reported
|
2 participants
|
0 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)
Aspartate Aminotransferase; Grade 1
|
34 participants
|
18 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)
Aspartate Aminotransferase; Grade 2
|
7 participants
|
7 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)
Aspartate Aminotransferase; Grade 3
|
3 participants
|
1 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)
Aspartate Aminotransferase; Grade Not reported
|
2 participants
|
0 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)
Low Calcium ; Grade 1
|
16 participants
|
6 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)
Low Calcium ; Grade 2
|
2 participants
|
1 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)
Low Calcium ; Grade 4
|
1 participants
|
2 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)
Low Calcium ; Grade Not reported
|
2 participants
|
0 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)
High Calcium ; Grade 1
|
8 participants
|
12 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)
High Calcium ; Grade Not reported
|
2 participants
|
0 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)
Creatinine; Grade 1
|
13 participants
|
13 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)
Creatinine; Grade 2
|
3 participants
|
1 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)
Creatinine; Grade Not reported
|
2 participants
|
0 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)
Bilirubin; Grade 1
|
2 participants
|
6 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)
Bilirubin; Grade 3
|
0 participants
|
1 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)
Bilirubin; Grade Not reported
|
3 participants
|
0 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)
Albumin; Grade 1
|
9 participants
|
6 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)
Albumin; Grade 2
|
6 participants
|
3 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)
Albumin; Grade Not reported
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment. Median duration (on-study time) was 14.29 and 15.29 weeks for dasatinib and placebo groups, respectively.Population: All treated participants.
Grade (GR)1= mild, GR2= moderate, GR3= severe, GR4= life threatening. Ranges are provided by the local laboratory and may vary according to sex and age. Phosphorous, GR1:\<LLN 2.5 mg/dL, GR2:\<2.5-2.0 mg/dL, GR3: 1.0-\<2.0 mg/dL; Low sodium,GR1:\<LLN 130mmol/L, GR3:120-\<130 mmol/L; High Magnesium, GR1 \>ULN 3.0 mg/dL,GR 3:\<0.3 0.8mg/dL; Uric acid, GR1:\>ULN 10 mg/dL, GR4:\>10 mg/dL; Low potassium, GR1:\<LLN 3.0mmol/L,GR3:\<3.0 2.5mmol/L; High potassium, GR1:\>ULN-5.5 mmol/L, GR2:\>5.5-6.0 mmol/L; Bicarbonate, GR1:\<LLN-16 mmol/L; GR2:\<16 - 11 mmol/L; Hig sodium, GR1:\>ULN-150 mmol/L,GR2:\>150-155 mmol/L.
Outcome measures
| Measure |
Exemestane + Dasatinib
n=79 Participants
Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
|
Exemestane + Placebo
n=76 Participants
Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
|
|---|---|---|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)
Low Sodium; Grade 1
|
16 participants
|
10 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)
Low Sodium; Grade 3
|
1 participants
|
0 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)
Low Sodium; Grade Not reported
|
3 participants
|
0 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)
Inorganic Phosphorus; Grade 1
|
2 participants
|
1 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)
Inorganic Phosphorus; Grade 2
|
7 participants
|
8 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)
Inorganic Phosphorus; Grade 3
|
5 participants
|
1 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)
Inorganic Phosphorus; Grade Not reported
|
3 participants
|
4 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)
Low Magnesium; Grade 1
|
4 participants
|
6 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)
Low Magnesium; Grade 3
|
1 participants
|
1 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)
Low Magnesium; Grade 4
|
0 participants
|
1 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)
Low Magnesium; Grade Not reported
|
7 participants
|
2 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)
Uric acid; Grade 1
|
16 participants
|
18 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)
Uric acid; Grade 4
|
2 participants
|
0 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)
Uric acid; Grade Not reported
|
2 participants
|
0 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)
Low Potassium; Grade 1
|
11 participants
|
4 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)
Low Potassium; Grade 3
|
1 participants
|
0 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)
Low Potassium; Grade Not reported
|
3 participants
|
0 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)
High Potassium; Grade 1
|
5 participants
|
6 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)
High Potassium; Grade 2
|
2 participants
|
0 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)
High Potassium; Grade Not reported
|
3 participants
|
0 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)
Bicarbonate; Grade 1
|
11 participants
|
8 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)
Bicarbonate; Grade 2
|
0 participants
|
1 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)
Bicarbonate; Grade Not reported
|
19 participants
|
14 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)
High Magnesium; Grade 1
|
10 participants
|
5 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)
High Magnesium; Grade 2
|
2 participants
|
2 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)
High Magnesium; Grade 3
|
2 participants
|
1 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)
High Magnesium; Grade Not reported
|
7 participants
|
2 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)
High Sodium; Grade 1
|
2 participants
|
1 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)
High Sodium; Grade 2
|
1 participants
|
0 participants
|
|
Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)
High Sodium; Grade Not reported
|
3 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment.Outcome measures
Outcome data not reported
Adverse Events
Exemestane + Dasatinib
Serious events: 22 serious events
Other events: 74 other events
Deaths: 0 deaths
Exemestane + Placebo
Serious events: 13 serious events
Other events: 61 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exemestane + Dasatinib
n=79 participants at risk
Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
|
Exemestane + Placebo
n=76 participants at risk
Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/79
|
1.3%
1/76
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.3%
1/79
|
0.00%
0/76
|
|
Vascular disorders
Phlebitis
|
1.3%
1/79
|
0.00%
0/76
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
1.3%
1/79
|
0.00%
0/76
|
|
Cardiac disorders
Right ventricular dysfunction
|
1.3%
1/79
|
0.00%
0/76
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/79
|
1.3%
1/76
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.00%
0/79
|
1.3%
1/76
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/79
|
1.3%
1/76
|
|
Infections and infestations
Lymphangitis
|
1.3%
1/79
|
0.00%
0/76
|
|
Nervous system disorders
Paraesthesia
|
1.3%
1/79
|
0.00%
0/76
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/79
|
1.3%
1/76
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.3%
1/79
|
1.3%
1/76
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
1/79
|
0.00%
0/76
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
1.3%
1/79
|
0.00%
0/76
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
1.3%
1/79
|
2.6%
2/76
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.5%
2/79
|
0.00%
0/76
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
2/79
|
2.6%
2/76
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/79
|
1.3%
1/76
|
|
Nervous system disorders
Amnesia
|
1.3%
1/79
|
0.00%
0/76
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/79
|
1.3%
1/76
|
|
General disorders
Mucosal inflammation
|
1.3%
1/79
|
0.00%
0/76
|
|
General disorders
Performance status decreased
|
1.3%
1/79
|
0.00%
0/76
|
|
General disorders
Sudden death
|
1.3%
1/79
|
0.00%
0/76
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/79
|
1.3%
1/76
|
|
Gastrointestinal disorders
Dysphagia
|
1.3%
1/79
|
0.00%
0/76
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.9%
7/79
|
1.3%
1/76
|
|
Nervous system disorders
Cerebrovascular accident
|
1.3%
1/79
|
0.00%
0/76
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/79
|
1.3%
1/76
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/79
|
1.3%
1/76
|
|
Infections and infestations
Pneumonia
|
2.5%
2/79
|
0.00%
0/76
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.3%
1/79
|
0.00%
0/76
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.6%
6/79
|
3.9%
3/76
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/79
|
1.3%
1/76
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/79
|
1.3%
1/76
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
1.3%
1/79
|
0.00%
0/76
|
|
General disorders
Disease progression
|
1.3%
1/79
|
0.00%
0/76
|
Other adverse events
| Measure |
Exemestane + Dasatinib
n=79 participants at risk
Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
|
Exemestane + Placebo
n=76 participants at risk
Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.3%
5/79
|
1.3%
1/76
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.1%
8/79
|
13.2%
10/76
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.3%
16/79
|
10.5%
8/76
|
|
Blood and lymphatic system disorders
Anaemia
|
8.9%
7/79
|
7.9%
6/76
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.1%
4/79
|
5.3%
4/76
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
4/79
|
9.2%
7/76
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.3%
5/79
|
7.9%
6/76
|
|
Gastrointestinal disorders
Constipation
|
19.0%
15/79
|
14.5%
11/76
|
|
Gastrointestinal disorders
Diarrhoea
|
31.6%
25/79
|
9.2%
7/76
|
|
General disorders
Oedema peripheral
|
8.9%
7/79
|
2.6%
2/76
|
|
General disorders
Pyrexia
|
12.7%
10/79
|
3.9%
3/76
|
|
Gastrointestinal disorders
Stomatitis
|
1.3%
1/79
|
5.3%
4/76
|
|
Gastrointestinal disorders
Vomiting
|
25.3%
20/79
|
18.4%
14/76
|
|
Gastrointestinal disorders
Abdominal pain
|
7.6%
6/79
|
3.9%
3/76
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.8%
3/79
|
5.3%
4/76
|
|
General disorders
Face oedema
|
5.1%
4/79
|
0.00%
0/76
|
|
Vascular disorders
Hot flush
|
5.1%
4/79
|
7.9%
6/76
|
|
Psychiatric disorders
Insomnia
|
10.1%
8/79
|
5.3%
4/76
|
|
Eye disorders
Vision blurred
|
5.1%
4/79
|
0.00%
0/76
|
|
Investigations
Alanine aminotransferase increased
|
7.6%
6/79
|
2.6%
2/76
|
|
Gastrointestinal disorders
Dyspepsia
|
6.3%
5/79
|
6.6%
5/76
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
4/79
|
3.9%
3/76
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.1%
4/79
|
10.5%
8/76
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
19.0%
15/79
|
1.3%
1/76
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.2%
12/79
|
6.6%
5/76
|
|
Nervous system disorders
Dizziness
|
7.6%
6/79
|
2.6%
2/76
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.1%
4/79
|
0.00%
0/76
|
|
General disorders
Fatigue
|
22.8%
18/79
|
15.8%
12/76
|
|
Nervous system disorders
Headache
|
26.6%
21/79
|
18.4%
14/76
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.1%
4/79
|
5.3%
4/76
|
|
General disorders
Oedema
|
6.3%
5/79
|
0.00%
0/76
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.1%
4/79
|
5.3%
4/76
|
|
Infections and infestations
Bronchitis
|
5.1%
4/79
|
0.00%
0/76
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.3%
20/79
|
5.3%
4/76
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.1%
4/79
|
7.9%
6/76
|
|
Gastrointestinal disorders
Nausea
|
36.7%
29/79
|
30.3%
23/76
|
|
Investigations
Aspartate aminotransferase increased
|
7.6%
6/79
|
2.6%
2/76
|
|
General disorders
Asthenia
|
26.6%
21/79
|
10.5%
8/76
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.5%
13/79
|
6.6%
5/76
|
|
General disorders
Influenza like illness
|
5.1%
4/79
|
0.00%
0/76
|
|
Cardiac disorders
Palpitations
|
7.6%
6/79
|
2.6%
2/76
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER