HER2-Negative Metastatic Breast Cancer
Conditions
Interventions
investigational material(s)
Generic name etc : RO4876646 (Bevacizumab) /Paclitaxel
INN of investigational material : Bevacizumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Admin
Sponsors
Chugai Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically or cytologically confirmed, HER2-negative adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease. - Locally recurrent disease must not be amenable to resection with curative intent. - ECOG performance status of 0 or 1 - For women of childbearing potential, use of an acceptable and effective method of non-hormonal contraception - For patients who have received recent radiotherapy, recovery prior to randomization from any significant acute toxicity, and radiation treatments have to be completed more than 3 weeks from randomization
Exclusion criteria
Exclusion criteria: Disease-Specific Exclusions: - HER2-positive status - Prior chemotherapy for locally recurrent or metastatic disease - Prior hormonal therapy < 2 weeks prior to randomization - Prior adjuvant or neo-adjuvant chemotherapy is allowed, provided its conclusion has been for at least 12 months prior to randomization - Investigational therapy within 28 days of randomization General Medical Exclusions: - Life expectancy of < 12 weeks - Inadequate organ function - Uncontrolled serious medical or psychiatric illness - Active infection requiring intravenous (IV) antibiotics at screening - Pregnancy or lactation - History of other malignancies within 5 years prior to screening, except for tumors with a negligible risk for metastasis or death
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy - Progression-free survival based on investigator tumor assessment in the intent-to-treat patient population - Progression-free survival based on investigator tumor assessment in intent-to-treat patients with high plasma vascular endothelial growth factor A levels RECIST v1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy - Overall survival - Objective response rate for patients with measurable disease at baseline, defined as complete or partial response as assessed by investigator according to RECIST v1.1 - Duration of objective response for patients with measurable disease at baseline, as determined by investigator review of tumor assessments using RECIST v1.1 - One-year survival rate RECIST v1.1 | — |
Countries
Africa, Asia except Japan, Europe, Japan, North America, South America
Outcome results
None listed