Status:
COMPLETED
A Study to Compare Eribulin Mesylate + Pertuzumab + Trastuzumab With Paclitaxel or Docetaxel + Pertuzumab + Trastuzumab
Lead Sponsor:
Japan Breast Cancer Research Group
Collaborating Sponsors:
Eisai Co., Ltd.
Conditions:
Breast Cancer
Eligibility:
FEMALE
20-70 years
Phase:
PHASE3
Brief Summary
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 c...
Eligibility Criteria
Inclusion
- Patients with breast cancer that is confirmed histologically or cytologically
- Patients who are confirmed to be HER2 positive for the primary or a metastatic lesion at a participating medical institution
- Patients with no medical history of treatment for advanced/recurrent cancer using a regimen of drugs including chemotherapeutics
- \>=6 months have passed since perioperative treatment with anticancer agents
- Presence of a measurable lesion not required
- Female aged 20-70 years old at the time of consent acquisition
- Baseline left ventricular ejection fraction (LVEF) measured by ECHO or MUGA of \>=50%
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1
- Patients who have maintained major organ functions, meeting all of the following criteria on a test within 28 days before enrollment. If there are multiple test results during this period, that obtained immediately before enrollment should be adopted.
- (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
- Patients planning to undergo radical surgery if they respond to a treatment
- Patients who have non-hematological adverse events assessed as Grade \>=3 in the Common Terminology Criteria for Adverse Events ver. 4.0 in the Japanese JCOG version (CTCAE v4.0-JCOG) at the time of enrollment
- Patients who have symptomatic metastases to the central nervous system or whose symptoms are hard to control
- Patients who have active double cancer
- Patients who have poorly controlled hypertension, or unstable angina
- Patients who have a past history of congestive heart failure assessed as Class ll or higher in the New York Heart Association (NYHA) classification, or clinically significant arrhythmia requiring treatment
- Patients with a past history of myocardial infarction within 6 months before enrollment
- Patients who are expected to undergo major surgical treatment or who had severe injury within 28 days before enrollment, or who require major surgical treatment during the study treatment period
- Patients with interstitial pneumonia which is symptomatic or requires treatment
- Pregnant women, those with a positive pregnancy test, and lactating women
- Patients with active systemic infection (including HCV and HBV), or who are found to be HIV-positive
- Patients with hypersensitivity against pertuzumab and trastuzumab
- Patients whom the investigator consider unable or unwilling to follow the protocol requirements
Key Trial Info
Start Date :
August 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
446 Patients enrolled
Trial Details
Trial ID
NCT03264547
Start Date
August 28 2017
End Date
December 31 2024
Last Update
September 29 2025
Active Locations (2)
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1
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan, 241-8515
2
National Hospital Organization Osaka National Hospital
Osaka, Osaka, Japan, 540-0006