Clinical trial · Interventional
Safety and Efficacy of Exemestane Plus Dasatinib Versus Placebo for Advanced ER+ Breast Cancer
A Randomized, Double-Blind, Multi-Center Phase II Trial of Exemestane (Aromasin®) Plus Dasatinib Versus Exemestane Plus Placebo in Advanced Estrogen Receptor-Positive Breast Cancer After Disease Progression on a Non-Steroidal Aromatase Inhibitor (NSAI)
NCT00767520CI-TRIAL-00009590completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exemestane + Dasatinib | Drug | — | UNRESOLVED |
| Exemestane + Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- interventionNames
- Drug: Exemestane + Dasatinib
- type
- PLACEBO_COMPARATOR
- label
- B
- interventionNames
- Drug: Exemestane + Placebo
Primary outcomes (2)
- measure
- Progression Free Survival (PFS) Distribution for Exemestane Plus Dasatinib vs Exemestane Plus Placebo
- timeFrame
- Prior to study therapy, at 8 week intervals until progression occurs (maximum participant PFS of 71 weeks)
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.