Phase 2
N=52
Gemcitabine Plus Bevacizumab in Locally Recurrent or Metastatic Breast Cancer
Metastatic Breast Cancer · Locally Advanced Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00623233 ↗Enrolled (actual)
52
Serious AEs
34.6%
Results posted
Jan 2012
Primary outcome: Primary: Progression Free Survival (PFS) Time — 4.80 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gemcitabine (Drug); Bevacizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) Time |
4.80 | — |
| SECONDARY Overall Tumor Response Rate (ORR) |
0.214 | — |
| SECONDARY Number of Participants With Adverse Events (AEs); Pharmacology Toxicities |
18; 51 | — |
| SECONDARY 1-Year Overall Survival (OS) Rate |
68.68 | — |
Summary
To determine how long Gemcitabine and Bevacizumab will stop the cancer from growing in patients with advanced breast cancer.
Eligibility Criteria
Inclusion Criteria
- Must be female and greater than or equal to 18 yrs of age
- Participants must have confirmed cancer with measurable or evaluable, locally recurrent or metastatic disease.
- Participants must have received a taxane as neo-adjuvant and/or adjuvant therapy
- Participants may have received prior hormone therapy for locally recurrent or metastatic disease
Exclusion Criteria
- Participants with breast cancer overexpressing Human Epidermal growth factor Receptor 2 (HER2) gene amplification
- Prior chemotherapy or targeted therapy for metastatic breast cancer
- Prior treatment with gemcitabine, trastuzumab, lapatinib or bevacizumab in any setting
- History of, or active brain mets
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to treatment, or anticipation of need for major surgical procedure during course of study
- Prior history of high blood pressure crisis
- Have a serious, nonhealing wound, ulcer, or bone fracture
Data sourced from ClinicalTrials.gov (NCT00623233). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.