At a glance
ClinicalIndex Comparison Record- ✓Female age 18 or older
- ✓Histologically or cytologically confirmed adenocarcinoma of the breast
- ✓Stage IV disease with at least one measurable lesion per RECIST criteria
- ✓HER2-negative disease confirmed by fluorescence in situ hybridization
- ✕Prior chemotherapy for metastatic breast cancer
- ✕Prior treatment with an anti-angiogenic agent
- ✕Current or prior history of CNS or brain metastases
- ✕Peripheral neuropathy grade > 2 (NCI-CTC v3.0) at baseline
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Phase II Trial of Docetaxel With or Without Bevacizumab as First-Line Therapy for Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Metastatic Breast Cancer
In Brief
A Phase 2 clinical trial evaluating bevacizumab and Docetaxel for Breast Cancer. Completed, enrolled 76 participants across 1 site.
Detailed Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by stopping blood flow to the tumor. It is not yet known whether giving docetaxel together with bevacizumab is more effective than docetaxel alone in treating breast cancer. PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with bevacizumab works compared to docetaxel alone as first-line therapy in treating women with stage IV breast cancer.
Study Details
Timeline
Interventions
Patients receive bevacizumab 15 mg/kg intravenously (I.V.) every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal.
docetaxel: 75 mg/m2 IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.