APHINITY trial

E261835

The APHINITY trial is a large phase III clinical study that evaluated the addition of pertuzumab (Perjeta) to standard trastuzumab-based adjuvant therapy in patients with HER2-positive early breast cancer.

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Predicate Object
instanceOf adjuvant breast cancer trial
phase III clinical trial
randomized controlled trial
acronym APHINITY
ageGroup adult patients
allocation randomized
biomarkerStatus HER2-positive
chemotherapyBackbone anthracycline-based regimens
non-anthracycline-based regimens
coDeveloperDrug Herceptin
Perjeta
controlRegimen trastuzumab plus chemotherapy
controlType placebo-controlled
diseaseStage early breast cancer
drugTarget HER2 receptor
evaluatedCombination pertuzumab plus trastuzumab plus chemotherapy
evaluatedDrug chemotherapy
pertuzumab
Herceptin
surface form: trastuzumab
fullName APHINITY trial self-linksurface differs
surface form: Adjuvant Pertuzumab and Herceptin IN Initial TherapY trial
geographicScope multicenter
multinational
impact influenced international breast cancer treatment guidelines
supported regulatory approval of pertuzumab in adjuvant HER2-positive early breast cancer
indication HER2-positive early breast cancer
interventionDuration 1 year of anti-HER2 therapy
keyFinding addition of pertuzumab improved invasive disease-free survival in HER2-positive early breast cancer
benefit was greater in node-positive patients
cardiac safety profile was acceptable
masking double-blind
mechanismOfActionContext dual HER2 blockade with pertuzumab and trastuzumab
population node-positive and high-risk node-negative patients
patients with operable HER2-positive breast cancer
presentedAt American Society of Clinical Oncology
surface form: American Society of Clinical Oncology Annual Meeting
primaryEndpoint invasive disease-free survival
publishedIn New England Journal of Medicine
registrationType pivotal trial
reportedInitialResultsYear 2017
safetyAssessment cardiac function monitoring
secondaryEndpoint cardiac safety
overall survival
sponsor Genentech
Roche
startYear mid-2000s
therapyLine curative-intent adjuvant therapy
treatmentSetting adjuvant
trialPhase Phase III

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Referenced by (2)

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

Perjeta clinicalTrial APHINITY trial
APHINITY trial fullName APHINITY trial self-linksurface differs
this entity surface form: Adjuvant Pertuzumab and Herceptin IN Initial TherapY trial