Clareo Health | Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer
Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
