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.

All labels observed (2)

How this entity was disambiguated

Statements (47)

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 ⓘ
trastuzumab ⓘ
linked to: Herceptin
fullName Adjuvant Pertuzumab and Herceptin IN Initial TherapY trial ⓘ
linked to: APHINITY 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 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 ⓘ

How these facts were elicited

Referenced by (2)

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

Perjeta → clinicalTrial → APHINITY trial ⓘ
APHINITY trial → fullName → Adjuvant Pertuzumab and Herceptin IN Initial TherapY trial ⓘ
linked to: APHINITY trial