CLinical Evaluation Of Pertuzumab And TRAstuzumab
E902898
CLinical Evaluation Of Pertuzumab And TRAstuzumab (CLEOPATRA) is a landmark phase III clinical trial that evaluated the addition of pertuzumab to trastuzumab and docetaxel in patients with HER2-positive metastatic breast cancer.
Observed surface forms (1)
| Surface form | Occurrences |
|---|---|
| CLEOPATRA trial | 0 |
Statements (47)
| Predicate | Object |
|---|---|
| instanceOf |
phase III clinical trial
ⓘ
randomized controlled trial ⓘ |
| acronym | CLEOPATRA ⓘ |
| biomarkerRequirement | HER2 overexpression or amplification ⓘ |
| cancerType | breast cancer ⓘ |
| chemotherapyBackbone | docetaxel ⓘ |
| combinationTherapy | dual HER2 blockade with pertuzumab and trastuzumab ⓘ |
| controlArm | placebo + trastuzumab + docetaxel ⓘ |
| designFeature |
double-blind
ⓘ
parallel-group ⓘ placebo-controlled ⓘ |
| diseaseStudied |
HER2-positive locally recurrent unresectable breast cancer
ⓘ
HER2-positive metastatic breast cancer ⓘ |
| docetaxelClass | taxane chemotherapy ⓘ |
| drugClassEvaluated | monoclonal antibody ⓘ |
| evaluatedDrug |
docetaxel
NERFINISHED
ⓘ
pertuzumab NERFINISHED ⓘ trastuzumab NERFINISHED ⓘ |
| fullName | CLinical Evaluation Of Pertuzumab And TRAstuzumab NERFINISHED ⓘ |
| geographicScope | multinational ⓘ |
| impact |
established dual HER2 blockade as a standard of care in metastatic HER2-positive breast cancer
ⓘ
supported regulatory approval of pertuzumab for first-line HER2-positive metastatic breast cancer ⓘ |
| interventionArm | pertuzumab + trastuzumab + docetaxel ⓘ |
| keyFinding |
addition of pertuzumab to trastuzumab and docetaxel significantly improved overall survival
ⓘ
addition of pertuzumab to trastuzumab and docetaxel significantly improved progression-free survival ⓘ safety profile of the pertuzumab regimen was acceptable ⓘ |
| landmarkStatus | landmark trial in HER2-positive metastatic breast cancer ⓘ |
| notablePublication | New England Journal of Medicine NERFINISHED ⓘ |
| patientPopulation |
ECOG performance status 0 or 1
ⓘ
previously untreated HER2-positive metastatic breast cancer ⓘ |
| pertuzumabTarget | HER2 dimerization domain ⓘ |
| primaryEndpoint |
overall survival
ⓘ
progression-free survival ⓘ |
| publicationType | peer-reviewed journal article ⓘ |
| randomizationRatio | 1:1 ⓘ |
| secondaryEndpoint |
duration of response
ⓘ
objective response rate ⓘ safety ⓘ |
| sponsor |
F. Hoffmann-La Roche Ltd
NERFINISHED
ⓘ
Genentech NERFINISHED ⓘ |
| targetMolecule | HER2 NERFINISHED ⓘ |
| therapeuticArea | oncology ⓘ |
| therapyType | HER2-targeted therapy ⓘ |
| trastuzumabTarget | HER2 extracellular domain NERFINISHED ⓘ |
| treatmentLine | first-line ⓘ |
| treatmentSetting | first-line treatment of metastatic disease ⓘ |
| trialPhase | phase III ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.