CLEOPATRA
E902899
CLEOPATRA is a clinical trial that evaluated the effectiveness and safety of combining pertuzumab with trastuzumab and docetaxel in patients with HER2-positive metastatic breast cancer.
Statements (42)
| Predicate | Object |
|---|---|
| instanceOf |
clinical trial
ⓘ
phase III clinical trial ⓘ |
| acronymFor | CLinical Evaluation Of Pertuzumab And TRAstuzumab ⓘ |
| allocation | randomized allocation ⓘ |
| biomarkerStatus | HER2-positive ⓘ |
| cancerType | metastatic breast cancer ⓘ |
| chemotherapyAgent | docetaxel NERFINISHED ⓘ |
| controlArmTreatment | trastuzumab plus docetaxel ⓘ |
| controlType | placebo control ⓘ |
| design |
double-blind
ⓘ
multicenter ⓘ placebo-controlled ⓘ randomized ⓘ |
| diseaseStage | metastatic ⓘ |
| drugClassEvaluated | HER2-targeted monoclonal antibodies ⓘ |
| evaluatedDrug |
docetaxel
ⓘ
pertuzumab NERFINISHED ⓘ trastuzumab NERFINISHED ⓘ |
| experimentalArmTreatment | pertuzumab plus trastuzumab plus docetaxel ⓘ |
| fullName | CLinical Evaluation Of Pertuzumab And TRAstuzumab NERFINISHED ⓘ |
| geographicScope | international trial ⓘ |
| HER2StatusAssessment | immunohistochemistry and/or in situ hybridization ⓘ |
| impact | established dual HER2 blockade with pertuzumab and trastuzumab as standard of care in first-line metastatic setting ⓘ |
| indication | HER2-positive metastatic breast cancer ⓘ |
| ledTo | regulatory approval of pertuzumab for HER2-positive metastatic breast cancer ⓘ |
| masking | double-blind masking ⓘ |
| patientSex | predominantly female patients ⓘ |
| population | previously untreated HER2-positive metastatic breast cancer patients ⓘ |
| primaryEndpoint |
overall survival
ⓘ
progression-free survival ⓘ |
| publicationType | landmark trial in HER2-positive metastatic breast cancer ⓘ |
| safetyOutcome | acceptable safety profile for pertuzumab plus trastuzumab plus docetaxel ⓘ |
| showedBenefit |
improved overall survival with pertuzumab combination
ⓘ
improved progression-free survival with pertuzumab combination ⓘ |
| sponsor |
Genentech
NERFINISHED
ⓘ
Roche NERFINISHED ⓘ |
| target | human epidermal growth factor receptor 2 NERFINISHED ⓘ |
| targetAbbreviation | HER2 ⓘ |
| therapyCategory | targeted therapy plus chemotherapy ⓘ |
| treatmentBackbone | taxane-based chemotherapy ⓘ |
| trialPhase | phase III ⓘ |
| trialType | interventional study ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.