Pertuzumab
DrugEvery 3 weeks
Other names: Perjeta
NCT Number: NCT03264547
To verify that combination therapy with trastuzumab + pertuzumab + eribulin brings similar PFS and better QOL compared to trastuzumab + pertuzumab + taxane in advanced/recurrent HER2-positive breast cancer patients who have no medical history of chemotherapy except ado-trastuzumab emtansine
Looking for future studies?
Notify Me20 year–70 year
Female
Interventional
Phase 3
Kanagawa Cancer Center, Yokohama, Kanagawa, Japan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(1) Neutrophil count: >=1,500/mm3 (2) Platelet count: >=100,000/mm 3 (3) Hemoglobin: >=9.0 g/dL (4) Total bilirubin: <=1.5 mg/dL (5) AST (GOT), ALT (GPT): <=2.5 times the ULN (<=5 times in those with liver metastasis) (6) Serum creatinine: <=1.5 mg/dL 10) Patients with a life expectancy of at least 6 months 11) Patient who submits written consent herself after receiving sufficient explanation about this study 12) Patients who can undergo QOL investigation
Exclusion criteria
Every 3 weeks
Other names: Perjeta
Every 3 weeks
Other names: Herceptin
Every 3 weeks
Other names: Taxotere
Every week
Other names: Taxol
Administered for 2 weeks and is then stopped to be administered for 1 week
Other names: Halaven
Time frame: 5.75 years
Progression-free survival
Time frame: 5.75 years
Response rate
Time frame: 5.75 years
Duration of response
Time frame: 6.25 years
Overall survival
Time frame: 5.75 years
Patient-reported outcomes(Numbness & tingling)
Time frame: 5.75 years
Time frame: 5.75 years
DNA mutation in the ctDNA and tumor tissue such as HER2,HER3, and PIK3CA
Time frame: 5.75 years
new Metastases free survival
Time frame: 5.75 years
Treatment duration of the following treatment
Japan Breast Cancer Research Group
Other
A Phase III Clinical Study to Compare the Combination Therapy of Eribulin Mesylate + Pertuzumab + Trastuzumab With Paclitaxel or Docetaxel + Pertuzumab + Trastuzumab (EMERALD)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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