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.
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 NERFINISHED ⓘ |
| 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 NERFINISHED ⓘ NSABP B-52 / B-46-like groups NERFINISHED ⓘ National Surgical Adjuvant Breast and Bowel Project NERFINISHED ⓘ |
| controlArmTreatment | trastuzumab plus chemotherapy ⓘ |
| design |
double-blind
ⓘ
multicenter ⓘ placebo-controlled ⓘ |
| evaluatesDrug |
chemotherapy
ⓘ
pertuzumab NERFINISHED ⓘ trastuzumab NERFINISHED ⓘ |
| experimentalArmTreatment | pertuzumab plus trastuzumab plus chemotherapy ⓘ |
| firstAuthor | Gunter von Minckwitz NERFINISHED ⓘ |
| fullName | Adjuvant Pertuzumab and Herceptin IN Initial TherapY of Breast Cancer NERFINISHED ⓘ |
| 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 GENERATED ⓘ |
| 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 NERFINISHED ⓘ |
| randomizationRatio | 1:1 ⓘ |
| regionOfEnrollment |
Asia
NERFINISHED
ⓘ
Europe NERFINISHED ⓘ North America NERFINISHED ⓘ South America NERFINISHED ⓘ |
| registration | ClinicalTrials.gov NCT01358877 NERFINISHED ⓘ |
| 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
NERFINISHED
ⓘ
Genentech NERFINISHED ⓘ |
| startYear | 2011 ⓘ |
| targetDisease |
HER2-positive early breast cancer
ⓘ
early-stage HER2-positive breast cancer ⓘ |
| therapeuticClassEvaluated | HER2-targeted monoclonal antibodies ⓘ |
| therapySetting | adjuvant therapy ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.