APHINITY

E902901

APHINITY is a large phase III clinical trial evaluating the benefit of adding pertuzumab to standard trastuzumab-based adjuvant therapy in patients with HER2-positive early breast cancer.

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Label Occurrences
APHINITY canonical 1

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Statements (49)

Predicate Object
instanceOf adjuvant breast cancer trial
clinical trial
phase III clinical trial
randomized controlled trial
acronymFor Adjuvant Pertuzumab and Herceptin IN Initial TherapY of Breast Cancer
blinding patients and investigators were blinded to pertuzumab vs placebo
chemotherapyBackbone anthracycline-based or non-anthracycline-based regimens
collaborator BIG 4-11
Breast International Group
NSABP B-52 / B-46-like groups
National Surgical Adjuvant Breast and Bowel Project
controlArmTreatment trastuzumab plus chemotherapy
design double-blind
multicenter
placebo-controlled
evaluatesDrug chemotherapy
pertuzumab
trastuzumab
linked to: Herceptin
experimentalArmTreatment pertuzumab plus trastuzumab plus chemotherapy
firstAuthor Gunter von Minckwitz
fullName Adjuvant Pertuzumab and Herceptin IN Initial TherapY of Breast Cancer
geographicScope international
HER2StatusInclusion HER2-positive
hormoneReceptorStatusInclusion hormone receptor–positive or hormone receptor–negative
interventionDuration 1 year of anti-HER2 therapy
keyFinding addition of pertuzumab improved invasive disease-free survival in node-positive patients
benefit of pertuzumab was more pronounced in higher-risk subgroups such as node-positive disease
population patients with operable HER2-positive early breast cancer
primaryAnalysisPublicationYear 2017
primaryEndpoint invasive disease-free survival
primaryObjective to evaluate the benefit of adding pertuzumab to standard trastuzumab-based adjuvant therapy
publicationVenue New England Journal of Medicine
randomizationRatio 1:1
regionOfEnrollment Asia
Europe
North America
South America
registration ClinicalTrials.gov NCT01358877
linked to: ClinicalTrials.gov
safetyFinding cardiac safety profile was acceptable and similar between arms
secondaryEndpoint cardiac safety
distant recurrence-free interval
overall survival
sponsor F. Hoffmann-La Roche Ltd
linked to: Roche

Genentech
startYear 2011
targetDisease HER2-positive early breast cancer
early-stage HER2-positive breast cancer
therapeuticClassEvaluated HER2-targeted monoclonal antibodies
therapySetting adjuvant therapy

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

APHINITY trial acronym APHINITY