NIPH Clinical Trials Search

A phase III clinical study to compare the combination therapy of eribulin mesylate + trastuzumab + pertuzumab with paclitaxel or Docetaxel + trastuzumab + pertuzumab

Basic Information

Recruitment status	Complete: follow-up continuing
Health condition(s) or Problem(s) studied	HER2-positive progressive-recurrent breast cancer
Date of first enrollment	2017/10/23
Target sample size	480
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Trastuzumab + pertuzumab + Taxane Taxane is chosen from the following; Docetaxel or Paclitaxel Trastuzumab+ Pertuzumab + Eribulin

Outcome(s)

Primary Outcome	Progression-free survival: PFS
Secondary Outcome	1.Response rate 2.Duration of response 3.Overall survival 4.Patient-reported outcomes 5.Safety 6.Biomaker 7.new Metastases free survival 8.Treatment duration of next treatment

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	70years-old
Gender	Female
Include criteria
Exclude criteria	1)Patients planning to undergo radical surgery if they respond to a treatment 2)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 3)Patients who have symptomatic metastases to the central nervous system or whose symptoms are hard to control 4)Patients who have active double cancer 5)Patients who have poorly controlled hypertension, or unstable angina 6)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 7)Patients with a past history of myocardial infarction within 6 months before enrollment 8)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 9)Patients with interstitial pneumonia which is symptomatic or requires treatment 10)Pregnant women, those with a positive pregnancy test, and lactating women 11)Patients with active systemic infection (including HCV and HBV), or who are found to be HIV-positive 12)Patients with hypersensitivity against pertuzumab and trastuzumab 13)Patients whom the investigator consider unable or unwilling to follow the protocol requirements