Breast Cancer
Conditions
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 cancer patients who have no medical history of chemotherapy except ado-trastuzumab emtansine
Interventions
DRUGPertuzumab
Every 3 weeks
DRUGTrastuzumab
Every 3 weeks
DRUGDocetaxel
Every 3 weeks
DRUGPaclitaxel
Every week
DRUGEribulin
Administered for 2 weeks and is then stopped to be administered for 1 week
Sponsors
Eisai Co., Ltd.
Japan Breast Cancer Research Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with breast cancer that is confirmed histologically or cytologically 2. Patients who are confirmed to be HER2 positive for the primary or a metastatic lesion at a participating medical institution 3. Patients with no medical history of treatment for advanced/recurrent cancer using a regimen of drugs including chemotherapeutics 4. \>=6 months have passed since perioperative treatment with anticancer agents 5. Presence of a measurable lesion not required 6. Female aged 20-70 years old at the time of consent acquisition 7. Baseline left ventricular ejection fraction (LVEF) measured by ECHO or MUGA of \>=50% 8. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1 9. 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 5.75 years | Progression-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DR | 5.75 years | Duration of response |
| OS | 6.25 years | Overall survival |
| PRO | 5.75 years | Patient-reported outcomes(Numbness & tingling) |
| RR | 5.75 years | Response rate |
| Biomaker | 5.75 years | DNA mutation in the ctDNA and tumor tissue such as HER2,HER3, and PIK3CA |
| nMFS | 5.75 years | new Metastases free survival |
| TTF of the subsequent treatment | 5.75 years | Treatment duration of the following treatment |
| Safety | 5.75 years | 1. Incidence of infusion reactions and left ventricular dysfunction 2. LVEF measurements during the study period 3. Incidence and severity of adverse events and serious adverse events 4. Abnormal laboratory test values |
Countries
Japan
Outcome results
None listed