A Randomized, Open-label Phase III Trial to Evaluate the Efficacy and Safety of Pertuzumab Retreatment in Previously Pertuzumab, Trastuzuamb and Chemotherapy Treated Her2-Positive Metastatic Locally Advanced and Metastatic Breast Cancer(Study of Perjeta re-treatment for clinical outcomes)
- Conditions
- HER2-positive locally advanced or metastatic breast cancer
- Registration Number
- JPRN-UMIN000018202
- Lead Sponsor
- Japan Breast Cancer Research Group (JBCRG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 219
Not provided
1.History of chemotherapy>4 regimen for locally advance or metastatic disease except for cancer chemotherapeutic agent-free treatment regimen 2.Persistent Grade>=3 non-hematologic toxicity according to CTCAE v4.0 resulting from previous therapy at the time of enrollment 3.Symptomatic or uncontrolled central nervous system metastases 4.Multiple malignancies without history of breast cancer 5.History of exposure to the following cumulative doses of anthracyclines: doxorubicin or liposomal doxorubicin>360mg/m2 epirubicin>720mg/m2 mitoxantrone>100mg/m2 If more than 1 anthracycline has been used, then the cumulative dose must not exceed the equivalent of 360mg/m2 of doxorubicin 6.Current uncontrolled hypertension or unstable angina 7.History of CHF of any NYHA criteria, or serious cardiac arrhythmia requiring treatment 8.History of myocardial infarction within 6 months of enrollment 9.Dyspnea at rest due to complications of advanced malignancy 10.Inadequate organ function, as determined by the following laboratory results, within 28 days before enrollment: Absolute neutrophil count<1,500/mm3 Platelet count<100,000/mm3 Hemoglobin<8.0g/dL Total bilirubin>2.0mg/dL, unless the patient has documented Gilbert's syndrome AST or ALT >100IU/L Serum creatinine value>2.0mg/dL or 177umol/L 11.Current severe uncontrolled systemic disease 12. Uncontrolled malignancy-associated hypercalcemia syndrome under bisphosphonates or denosumab treatment 13.Radiation related grade>=2 adverse event within 14 days before enrollment 14.Major surgical procedure or significant traumatic injury within 28 days before enrollment or anticipation of need for major surgery during the course of study treatment 15.Pregnant woman or positive pregnancy test 16.Nursing 17.History of receiving any investigational treatment within 28 days before enrollment 18.Current known and active infection with HIV 19.Receipt of intravenous antibiotics for infection within 14 days before enrollment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival (assessed by investigators)
- Secondary Outcome Measures
Name Time Method PFS (assessed by independent review), PFS in patients treated with trastuzumab emtansine (T-DM1) as the latest regimen, Response rate, Duration of response, Overall survival (OS), Patient-reported-outcome (QOL), Safety, biomarkers