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.

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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 ⓘ
pertuzumab ⓘ
trastuzumab ⓘ
linked to: Herceptin
fullName CLinical Evaluation Of Pertuzumab And TRAstuzumab ⓘ
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 ⓘ
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 ⓘ
linked to: Roche

Genentech ⓘ
targetMolecule HER2 ⓘ
linked to: ERBB2
therapeuticArea oncology ⓘ
therapyType HER2-targeted therapy ⓘ
trastuzumabTarget HER2 extracellular domain ⓘ
linked to: ERBB2
treatmentLine first-line ⓘ
treatmentSetting first-line treatment of metastatic disease ⓘ
trialPhase phase III ⓘ

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Referenced by (3)

Full triples — surface form annotated when it differs from this entity's canonical label.

CLEOPATRA trial → fullName → CLinical Evaluation Of Pertuzumab And TRAstuzumab ⓘ
CLEOPATRA trial → fullName → CLinical Evaluation Of Pertuzumab And TRAstuzumab ⓘ
CLEOPATRA → fullName → CLinical Evaluation Of Pertuzumab And TRAstuzumab ⓘ