Phase 2
Completed N=187
A Trial of Paclitaxel and Bevacizumab vs. Gemcitabine, Paclitaxel, and Bevacizumab in Advanced Breast Cancer
Source: ClinicalTrials.gov NCT00320541 ↗Enrolled (actual)
187
Serious AEs
33.7%
Results posted
Jul 2010
Primary outcomePrimary: Overall Response Rate (ORR) — 0.489; 0.587 proportion of responders — p=0.117
Summary
This study will compare the cancer response to both treatments for locally advanced or metastatic breast cancer
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) |
0.489; 0.587 | 0.117 |
| SECONDARY Progression-free Survival (PFS) |
8.8; 11.3 | 0.247 |
| SECONDARY Overall Survival |
25.0; 24.3 | 0.475 |
| SECONDARY Total Functional Assessment of Cancer Therapy -Breast (FACT-B): Change From Baseline to End of Therapy |
-1.0; -10.8 | 0.010 sig |
| SECONDARY Physical Well Being (PWB) Subscale: Change From Baseline to End of Therapy |
-1.9; -4.0 | 0.119 |
| SECONDARY Social/Family Well Being (SFWB) Subscale: Change From Baseline to End of Therapy |
0.0; -1.9 | 0.023 sig |
| SECONDARY Emotional Well Being (EWB) Subscale: Change From Baseline to End of Therapy |
1.8; -0.2 | 0.002 sig |
| SECONDARY Functional Well Being (FWB) Subscale: Change From Baseline to End of Therapy |
-0.3; -3.8 | 0.004 sig |
| SECONDARY Breast Cancer Subscale (BCS): Change From Baseline to End of Therapy |
-0.1; -1.9 | 0.067 |
| SECONDARY Trial Outcome Index-Breast (TOI-B): Change From Baseline to End of Therapy |
-2.5; -9.1 | 0.036 sig |
Eligibility Criteria
Inclusion Criteria
- Females diagnosed with breast cancer and the cancer has spread to distant areas of the breast or organs.
- Must be able to measure the disease by specific medical parameters
- May have received breast cancer treatment in the early stage of the disease
- May be restricted in physically strenuous activity but able to carry out light work.
- Must have adequate organ function as seen in blood test results.
Exclusion
Criteria:
- Cancer that has spread to the brain.
- Unstable heart problems
- Unstable high blood pressure.
- Breast cancer treatment after the disease has considered to spread to other areas or organs.
- Unable to agree with the requirements of the study
Data sourced from ClinicalTrials.gov (NCT00320541). 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. Informational only — not medical advice.