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.
All labels observed (1)
| Label | Occurrences |
|---|---|
| CLinical Evaluation Of Pertuzumab And TRAstuzumab canonical | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T11074746 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.
Target entity: CLinical Evaluation Of Pertuzumab And TRAstuzumab Context triple: [CLEOPATRA trial, fullName, CLinical Evaluation Of Pertuzumab And TRAstuzumab]
-
A.
pertuzumab
Pertuzumab is a monoclonal antibody used in targeted therapy for HER2-positive breast cancer, often administered alongside trastuzumab and chemotherapy.
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B.
HER2 receptor
The HER2 receptor is a cell surface protein and member of the epidermal growth factor receptor family that, when overexpressed, drives the growth of certain aggressive breast and other cancers.
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C.
Herceptin
Herceptin is a targeted monoclonal antibody drug used primarily to treat HER2-positive breast cancer by blocking the HER2 receptor on cancer cells.
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D.
ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals is an international regulatory guideline that outlines the nonclinical safety studies needed to support the development and approval of anticancer drugs in humans.
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E.
Ibrance
Ibrance is a targeted oral cancer medication (palbociclib) used primarily to treat certain types of hormone receptor–positive, HER2-negative advanced or metastatic breast cancer.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
Target entity: CLinical Evaluation Of Pertuzumab And TRAstuzumab Target entity description: 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.
-
A.
pertuzumab
Pertuzumab is a monoclonal antibody used in targeted therapy for HER2-positive breast cancer, often administered alongside trastuzumab and chemotherapy.
-
B.
HER2 receptor
The HER2 receptor is a cell surface protein and member of the epidermal growth factor receptor family that, when overexpressed, drives the growth of certain aggressive breast and other cancers.
-
C.
Herceptin
Herceptin is a targeted monoclonal antibody drug used primarily to treat HER2-positive breast cancer by blocking the HER2 receptor on cancer cells.
-
D.
ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals is an international regulatory guideline that outlines the nonclinical safety studies needed to support the development and approval of anticancer drugs in humans.
-
E.
Ibrance
Ibrance is a targeted oral cancer medication (palbociclib) used primarily to treat certain types of hormone receptor–positive, HER2-negative advanced or metastatic breast cancer.
- F. None of above. chosen
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
NERFINISHED
ⓘ
pertuzumab NERFINISHED ⓘ trastuzumab NERFINISHED ⓘ |
| fullName | CLinical Evaluation Of Pertuzumab And TRAstuzumab NERFINISHED ⓘ |
| 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 NERFINISHED ⓘ |
| 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
NERFINISHED
ⓘ
Genentech NERFINISHED ⓘ |
| targetMolecule | HER2 NERFINISHED ⓘ |
| therapeuticArea | oncology ⓘ |
| therapyType | HER2-targeted therapy ⓘ |
| trastuzumabTarget | HER2 extracellular domain NERFINISHED ⓘ |
| treatmentLine | first-line ⓘ |
| treatmentSetting | first-line treatment of metastatic disease ⓘ |
| trialPhase | phase III ⓘ |
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Subject: CLinical Evaluation Of Pertuzumab And TRAstuzumab Description of subject: 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.
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.