Inoperable metastatic breast cancer
Conditions
Interventions
investigational material(s)
Generic name etc : R435 (Bevacizumab)|paclitaxel
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Inv
Sponsors
Chugai Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: - at least 20 years old and obtained a written informed consent - Advanced breast cancer (Stage IV) or Inoperable metastatic breast cancer - HER2 negative - At least one measurable lesion based on RECIST criteria - No previous chemotherapy for metastatic breast cancer
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints: Safety, Progression-free survival (PFS) Secondary endpoints: Tumor response (Response rate, duration of response, Time to response), Overall survival (OS), Time to treatment failure (TTF) | — |
Outcome results
None listed