Breast Cancer
Conditions
Keywords
Advanced Estrogen Receptor Positive Breast Cancer
Brief summary
The purpose of this study is to determine whether exemestane plus dasatinib will be well-tolerated and will increase progression-free survival (PFS) in the treatment of advanced estrogen-receptor positive (ER+) breast cancer after disease progression (PD) on a non-steroidal aromatase inhibitor (NSAI).
Interventions
DRUGExemestane + Dasatinib
Tablets, Oral, Exemestane 25 mg + Dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
DRUGExemestane + Placebo
Tablets, Oral, Exemestane 25 mg + Placebo 100 mg, once daily, until disease progression or unacceptable toxicity
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically-documented invasive estrogen receptor positive breast cancer , with tumor tissue from prior surgery available for analysis * Prior therapy with a non-steroidal aromatase inhibitor * Recurrent or progressive advanced breast cancer (locally-advanced or metastatic) * Documented breast cancer with tumor ≤ 28 days prior to study entry * Women who are NOT of childbearing potential * Must be able to take oral medication * Performance Status 0 or 1
Exclusion criteria
* Pleural or pericardial effusion or ascites (of any etiology; Grade ≥ 1) within 6 months prior to study entry * Any chemotherapy, immunotherapy \< 6 months before study entry. Any targeted therapy (eg. lapatinib) \< 6 months before study entry, unless given in combination with an NSAI * Any antitumor therapy, including radiotherapy or hormonal therapy, within 15 days prior to study entry * Prior exposure to exemestane, any Src-family kinase inhibitor including dasatinib, to agents intended to control osteolytic disease other than bisphosphonates, or to any investigational agent for breast cancer * Concurrent or previous malignant disease requiring chemotherapy or radiation treatment within the prior 3 years * Significant bleeding disorder, or ongoing or recent clinically-significant gastrointestinal bleeding * Any serious cardiac condition, including congestive heart failure or myocardial infarction within 6 months, uncontrolled angina, or Class III or IV heart disease as defined by the New York Heart Association, baseline ejection fraction ≤ 40%, diagnosed congenital long QT syndrome, clinically-significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes), QTc interval \> 450 msec at baseline (Fridericia correction) * Hematologic abnormality Grade ≥ 2 * Hypocalcemia of Grade ≥ 1 * Any Chemistry abnormality of Grade ≥ 2 \[except Grade 2 indirect bilirubin permitted if diagnosed Gilbert's disease\] * Pregnant Women and Women of Childbearing Potential (WOCBP) * Extremely lactose intolerant, in the judgment of treating physician (100 mg dasatinib contains 135 mg lactose, posing a problem only if intolerance is severe) * Receiving any of the following concomitant medications: Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Subjects must discontinue drug use at least 7 days prior to starting dasatinib) * Potent inhibitors of CYP3A4 isoenzyme * Prisoners or subjects who are involuntarily incarcerated; or subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) Distribution for Exemestane Plus Dasatinib vs Exemestane Plus Placebo | Prior to study therapy, at 8 week intervals until progression occurs (maximum participant PFS of 71 weeks) | 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). |
| Participants With Disease Progression or Death for Exemestane Plus Dasatinib vs Exemestane Plus Placebo | Prior to study therapy, at 8 week intervals until progression occurs. Maximum participant PFS of ____ months) | PD is an increase (≥ 20%) in sum of longest diameters from smallest value during study (including baseline). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Clinical Benefit (CB) for Exemestane Plus Dasatinib Arm vs Exemestane Plus Placebo Arm at 6 Months | at 6 months | 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. |
| Percentage of Participants With Response in Exemestane Plus Dasatinib Arm and Exemestane Plus Placebo Arms | Prior to study therapy, at 8 week intervals until progression occurs (maximum participant response was 39 weeks) | 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. |
| Participants With Freedom-From-Progression (FFP) at 6 Months | at 6 months | FFP at month 6 is defined for the randomized participants who had the probability of neither progressing nor dying before 6 months. |
| Time to Response for Exemestane Plus Dasatinib Arm and Exemestane Plus Placebo Arms | 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 longer | Time 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. |
| Duration of Response for Exemestane Plus Dasatinib Arm and Exemestane Plus Placebo Arms | 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). |
| Changes in Participant-reported Pain Intensity in Participants With Bone Metastasis | 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. |
| Number of Participants With Abnormalities in Vital Signs | 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. | — |
| Number of Participants With Abnormalities in Electrocardiograms | 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. | — |
| 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) | 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. | 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. |
| Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | 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. | 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. |
| 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) | 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. | 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. |
| 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) | 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. | 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. |
| Changes in Markers of Bone Lysis in Participants With Bone Metastasis | 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. |
| Number of Participants With Best Overall Response | at 6 months | 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). |
Countries
Czechia, France, Ireland, Poland, Spain, Sweden, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exemestane + Dasatinib Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity | 79 |
| Exemestane + Placebo Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity | 78 |
| Total | 157 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Participants still on treatment | 11 | 15 |
| Overall Study | Randomized in error and Never treated | 0 | 2 |
Baseline characteristics
| Characteristic | Exemestane + Dasatinib | Exemestane + Placebo | Total |
|---|---|---|---|
| Age Continuous | 63.2 Years STANDARD_DEVIATION 12.19 | 60.1 Years STANDARD_DEVIATION 10.43 | 61.7 Years STANDARD_DEVIATION 11.41 |
| Age, Customized < 50 years | 9 participants | 10 participants | 19 participants |
| Age, Customized >=50 years | 69 participants | 68 participants | 137 participants |
| Age, Customized Not reported | 1 participants | 0 participants | 1 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0=normal activity | 46 participants | 46 participants | 92 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 1=symptoms, but fully ambulatory | 32 participants | 30 participants | 62 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Not reported | 1 participants | 2 participants | 3 participants |
| Race/Ethnicity, Customized Asian | 11 participants | 19 participants | 30 participants |
| Race/Ethnicity, Customized Hispanic / Latino | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Not Hispanic / Not Latino | 9 participants | 8 participants | 17 participants |
| Race/Ethnicity, Customized Not reported | 69 participants | 70 participants | 139 participants |
| Race/Ethnicity, Customized Other | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 68 participants | 58 participants | 126 participants |
| Setting of Non-steroidal Aromatase Inhibitor Adjuvant | 27 participants | 27 participants | 54 participants |
| Setting of Non-steroidal Aromatase Inhibitor Advanced | 52 participants | 51 participants | 103 participants |
| Sex: Female, Male Female | 78 Participants | 78 Participants | 156 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
| Symptomatic Bone Disease No | 48 participants | 46 participants | 94 participants |
| Symptomatic Bone Disease Yes | 31 participants | 32 participants | 63 participants |
| Time from Initial diagnosis to randomization | 97.63 months STANDARD_DEVIATION 74.866 | 87.09 months STANDARD_DEVIATION 64.743 | 92.46 months STANDARD_DEVIATION 70.058 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 74 / 79 | 61 / 76 |
| serious Total, serious adverse events | 22 / 79 | 13 / 76 |
Outcome results
Primary
Participants With Disease Progression or Death for Exemestane Plus Dasatinib vs Exemestane Plus Placebo
PD is an increase (≥ 20%) in sum of longest diameters from smallest value during study (including baseline).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exemestane + Dasatinib | Participants With Disease Progression or Death for Exemestane Plus Dasatinib vs Exemestane Plus Placebo | Disease Progression | 56 participants |
| Exemestane + Dasatinib | Participants With Disease Progression or Death for Exemestane Plus Dasatinib vs Exemestane Plus Placebo | Censored | 19 participants |
| Exemestane + Dasatinib | Participants With Disease Progression or Death for Exemestane Plus Dasatinib vs Exemestane Plus Placebo | Death | 4 participants |
| Exemestane + Placebo | Participants With Disease Progression or Death for Exemestane Plus Dasatinib vs Exemestane Plus Placebo | Disease Progression | 59 participants |
| Exemestane + Placebo | Participants With Disease Progression or Death for Exemestane Plus Dasatinib vs Exemestane Plus Placebo | Censored | 19 participants |
| Exemestane + Placebo | Participants With Disease Progression or Death for Exemestane Plus Dasatinib vs Exemestane Plus Placebo | Death | 0 participants |
Primary
Progression Free Survival (PFS) Distribution for Exemestane Plus Dasatinib vs Exemestane Plus Placebo
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).
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Exemestane + Dasatinib | Progression Free Survival (PFS) Distribution for Exemestane Plus Dasatinib vs Exemestane Plus Placebo | 18.1 weeks |
| Exemestane + Placebo | Progression Free Survival (PFS) Distribution for Exemestane Plus Dasatinib vs Exemestane Plus Placebo | 16.1 weeks |
p-value: 0.148Un-stratified log-rank test
Secondary
Changes in Markers of Bone Lysis in Participants With Bone Metastasis
Assay for urinary N-telopeptide was used to evaluate Osteolytic activity.
Time frame: 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.
Secondary
Changes in Participant-reported Pain Intensity in Participants With Bone Metastasis
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.
Time frame: 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.
Secondary
Duration of Response for Exemestane Plus Dasatinib Arm and Exemestane Plus Placebo Arms
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).
Time frame: 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.
Secondary
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)
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Placebo | 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 | 1 participants |
| Exemestane + Placebo | 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 | 2 participants |
| Exemestane + Placebo | 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 | 13 participants |
| Exemestane + Placebo | 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 | 4 participants |
| Exemestane + Placebo | 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 | 67 participants |
| Exemestane + Placebo | 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 | 48 participants |
| Exemestane + Placebo | 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 | 8 participants |
| Exemestane + Placebo | 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 | 6 participants |
Secondary
Number of Participants With Abnormalities in Electrocardiograms
Time frame: 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.
Secondary
Number of Participants With Abnormalities in Vital Signs
Time frame: 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.
Secondary
Number of Participants With Best Overall Response
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).
Time frame: at 6 months
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exemestane + Dasatinib | Number of Participants With Best Overall Response | Complete response (CR) | 0 participants |
| Exemestane + Dasatinib | Number of Participants With Best Overall Response | Partial response (PR) | 3 participants |
| Exemestane + Dasatinib | Number of Participants With Best Overall Response | Stable Disease (SD) | 21 participants |
| Exemestane + Dasatinib | Number of Participants With Best Overall Response | Disease Progression | 15 participants |
| Exemestane + Dasatinib | Number of Participants With Best Overall Response | Unable to assess | 2 participants |
| Exemestane + Dasatinib | Number of Participants With Best Overall Response | Not reported | 8 participants |
| Exemestane + Placebo | Number of Participants With Best Overall Response | Disease Progression | 23 participants |
| Exemestane + Placebo | Number of Participants With Best Overall Response | Complete response (CR) | 0 participants |
| Exemestane + Placebo | Number of Participants With Best Overall Response | Not reported | 11 participants |
| Exemestane + Placebo | Number of Participants With Best Overall Response | Partial response (PR) | 0 participants |
| Exemestane + Placebo | Number of Participants With Best Overall Response | Unable to assess | 1 participants |
| Exemestane + Placebo | Number of Participants With Best Overall Response | Stable Disease (SD) | 14 participants |
Secondary
Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0)
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exemestane + Dasatinib | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Granulocytes; Grade 1 | 18 participants |
| Exemestane + Dasatinib | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Granulocytes; Grade 2 | 10 participants |
| Exemestane + Dasatinib | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Granulocytes; Grade 3 | 2 participants |
| Exemestane + Dasatinib | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Granulocytes; Grade 4 | 0 participants |
| Exemestane + Dasatinib | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Granulocytes; Grade Not reported | 2 participants |
| Exemestane + Dasatinib | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Hemoglobin; Grade 1 | 42 participants |
| Exemestane + Dasatinib | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Hemoglobin; Grade 2 | 11 participants |
| Exemestane + Dasatinib | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Hemoglobin; Grade 3 | 1 participants |
| Exemestane + Dasatinib | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Hemoglobin; Grade 4 | 1 participants |
| Exemestane + Dasatinib | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Hemoglobin; Grade Not reported | 2 participants |
| Exemestane + Dasatinib | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Platelet Count; Grade 1 | 10 participants |
| Exemestane + Dasatinib | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Platelet Count; Grade 2 | 2 participants |
| Exemestane + Dasatinib | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Platelet Count; Grade 3 | 0 participants |
| Exemestane + Dasatinib | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Leukocytes; Grade 1 | 23 participants |
| Exemestane + Dasatinib | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Leukocytes; Grade 2 | 7 participants |
| Exemestane + Dasatinib | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Leukocytes; Grade 4 | 0 participants |
| Exemestane + Dasatinib | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Leukocytes; Grade Not reported | 2 participants |
| Exemestane + Dasatinib | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Platelet Count; Grade Not reported | 2 participants |
| Exemestane + Placebo | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Leukocytes; Grade Not reported | 0 participants |
| Exemestane + Placebo | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Granulocytes; Grade 1 | 9 participants |
| Exemestane + Placebo | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Hemoglobin; Grade Not reported | 0 participants |
| Exemestane + Placebo | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Granulocytes; Grade 2 | 1 participants |
| Exemestane + Placebo | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Leukocytes; Grade 1 | 12 participants |
| Exemestane + Placebo | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Granulocytes; Grade 3 | 0 participants |
| Exemestane + Placebo | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Platelet Count; Grade 1 | 2 participants |
| Exemestane + Placebo | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Granulocytes; Grade 4 | 2 participants |
| Exemestane + Placebo | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Leukocytes; Grade 4 | 1 participants |
| Exemestane + Placebo | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Granulocytes; Grade Not reported | 0 participants |
| Exemestane + Placebo | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Platelet Count; Grade 2 | 1 participants |
| Exemestane + Placebo | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Hemoglobin; Grade 1 | 21 participants |
| Exemestane + Placebo | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Leukocytes; Grade 2 | 2 participants |
| Exemestane + Placebo | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Hemoglobin; Grade 2 | 6 participants |
| Exemestane + Placebo | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Platelet Count; Grade 3 | 1 participants |
| Exemestane + Placebo | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Hemoglobin; Grade 3 | 2 participants |
| Exemestane + Placebo | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Platelet Count; Grade Not reported | 0 participants |
| Exemestane + Placebo | Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) | Hemoglobin; Grade 4 | 2 participants |
Secondary
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)
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Placebo | 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 | 0 participants |
| Exemestane + Placebo | 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 | 15 participants |
| Exemestane + Placebo | 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 | 10 participants |
| Exemestane + Placebo | 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 | 0 participants |
| Exemestane + Placebo | 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 | 0 participants |
| Exemestane + Placebo | 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 | 16 participants |
| Exemestane + Placebo | 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 | 3 participants |
| Exemestane + Placebo | 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 | 3 participants |
| Exemestane + Placebo | 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 | 0 participants |
| Exemestane + Placebo | 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 | 18 participants |
| Exemestane + Placebo | 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 |
| Exemestane + Placebo | 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 | 1 participants |
| Exemestane + Placebo | 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 | 0 participants |
| Exemestane + Placebo | 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 | 6 participants |
| Exemestane + Placebo | 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 | 1 participants |
| Exemestane + Placebo | 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 | 2 participants |
| Exemestane + Placebo | 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 | 0 participants |
| Exemestane + Placebo | 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 | 12 participants |
| Exemestane + Placebo | 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 | 0 participants |
| Exemestane + Placebo | 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 |
| Exemestane + Placebo | 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 | 1 participants |
| Exemestane + Placebo | 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 | 0 participants |
| Exemestane + Placebo | 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 | 6 participants |
| Exemestane + Placebo | 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 | 1 participants |
| Exemestane + Placebo | 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 | 0 participants |
| Exemestane + Placebo | 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 | 6 participants |
| Exemestane + Placebo | 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 | 3 participants |
Secondary
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)
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Dasatinib | 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 |
| Exemestane + Placebo | 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 | 0 participants |
| Exemestane + Placebo | 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 | 10 participants |
| Exemestane + Placebo | 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 | 2 participants |
| Exemestane + Placebo | 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 | 0 participants |
| Exemestane + Placebo | 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 | 0 participants |
| Exemestane + Placebo | 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 | 0 participants |
| Exemestane + Placebo | 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 | 5 participants |
| Exemestane + Placebo | 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 | 1 participants |
| Exemestane + Placebo | 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 | 6 participants |
| Exemestane + Placebo | 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 | 8 participants |
| Exemestane + Placebo | 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 | 0 participants |
| Exemestane + Placebo | 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 | 1 participants |
| Exemestane + Placebo | 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 | 0 participants |
| Exemestane + Placebo | 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 | 4 participants |
| Exemestane + Placebo | 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 |
| Exemestane + Placebo | 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 | 6 participants |
| Exemestane + Placebo | 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 | 0 participants |
| Exemestane + Placebo | 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 |
| Exemestane + Placebo | 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 | 1 participants |
| Exemestane + Placebo | 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 | 1 participants |
| Exemestane + Placebo | 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 | 2 participants |
| Exemestane + Placebo | 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 | 8 participants |
| Exemestane + Placebo | 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 | 18 participants |
| Exemestane + Placebo | 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 | 1 participants |
| Exemestane + Placebo | 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 | 0 participants |
| Exemestane + Placebo | 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 | 1 participants |
| Exemestane + Placebo | 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 | 0 participants |
| Exemestane + Placebo | 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 | 0 participants |
| Exemestane + Placebo | 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 | 4 participants |
| Exemestane + Placebo | 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 | 14 participants |
Secondary
Participants With Freedom-From-Progression (FFP) at 6 Months
FFP at month 6 is defined for the randomized participants who had the probability of neither progressing nor dying before 6 months.
Time frame: at 6 months
Secondary
Percentage of Participants With Clinical Benefit (CB) for Exemestane Plus Dasatinib Arm vs Exemestane Plus Placebo Arm at 6 Months
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.
Time frame: at 6 months
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exemestane + Dasatinib | 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 |
| Exemestane + Placebo | Percentage of Participants With Clinical Benefit (CB) for Exemestane Plus Dasatinib Arm vs Exemestane Plus Placebo Arm at 6 Months | 12.24 percentage of participants |
Secondary
Percentage of Participants With Response in Exemestane Plus Dasatinib Arm and Exemestane Plus Placebo Arms
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exemestane + Dasatinib | Percentage of Participants With Response in Exemestane Plus Dasatinib Arm and Exemestane Plus Placebo Arms | 6.12 percentage of participants |
| Exemestane + Placebo | Percentage of Participants With Response in Exemestane Plus Dasatinib Arm and Exemestane Plus Placebo Arms | 0 percentage of participants |
Secondary
Time to Response for Exemestane Plus Dasatinib Arm and Exemestane Plus Placebo Arms
Time 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.
Time frame: 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 longer