A Phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of bevacizumab, and associated biomarkers, in combination with paclitaxel
- Conditions
- HER2-Negative Metastatic Breast Cancer
- Registration Number
- JPRN-jRCT2080221950
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
The significant PFS improvement with bevacizumab is consistent with previous placebo-controlled first-line trials in mBC. Results do not support using baseline pVEGF-A to identify patients benefitting most from bevacizumab.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 481
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>- Progression-free survival based on investigator tumor assessment in the intent-to-treat patient population<br>- Progression-free survival based on investigator tumor assessment in intent-to-treat patients with high plasma vascular endothelial growth factor A levels<br>RECIST v1.1
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>- Overall survival<br>- 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<br>- Duration of objective response for patients with measurable disease at baseline, as determined by investigator review of tumor assessments using RECIST v1.1<br>- One-year survival rate<br>RECIST v1.1