Phase 2
Completed N=157
Safety and Efficacy of Exemestane Plus Dasatinib Versus Placebo for Advanced ER+ Breast Cancer
Source: ClinicalTrials.gov NCT00767520 ↗Enrolled (actual)
157
Serious AEs
22.6%
Results posted
Jun 2012
Primary outcomePrimary: Progression Free Survival (PFS) Distribution for Exemestane Plus Dasatinib vs Exemestane Plus Placebo — 18.1; 16.1 weeks — p=0.148
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) Distribution for Exemestane Plus Dasatinib vs Exemestane Plus Placebo |
18.1; 16.1 | 0.148 |
| PRIMARY Participants With Disease Progression or Death for Exemestane Plus Dasatinib vs Exemestane Plus Placebo |
56; 59; 4; 0; 19; 19 | — |
| SECONDARY Number of Participants With Best Overall Response |
0; 0; 3; 0; 21; 14 | — |
| SECONDARY Percentage of Participants With Clinical Benefit (CB) for Exemestane Plus Dasatinib Arm vs Exemestane Plus Placebo Arm at 6 Months |
30.61; 12.24 | — |
| SECONDARY Percentage of Participants With Response in Exemestane Plus Dasatinib Arm and Exemestane Plus Placebo Arms |
6.12; 0 | — |
| SECONDARY Participants With Freedom-From-Progression (FFP) at 6 Months |
— | — |
| SECONDARY Time to Response for Exemestane Plus Dasatinib Arm and Exemestane Plus Placebo Arms |
— | — |
| SECONDARY Duration of Response for Exemestane Plus Dasatinib Arm and Exemestane Plus Placebo Arms |
— | — |
| SECONDARY Changes in Participant-reported Pain Intensity in Participants With Bone Metastasis |
— | — |
| SECONDARY Changes in Markers of Bone Lysis in Participants With Bone Metastasis |
— | — |
| 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) |
10; 2; 22; 13; 10; 4 | — |
| SECONDARY Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0) |
18; 9; 10; 1; 2; 0 | — |
| 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) |
20; 15; 3; 10; 2; 0 | — |
| 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) |
16; 10; 1; 0; 3; 0 | — |
| SECONDARY Number of Participants With Abnormalities in Vital Signs |
— | — |
| SECONDARY Number of Participants With Abnormalities in Electrocardiograms |
— | — |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00767520). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.