Phase 2
N=21
VEGF Trap in Treating Patients With Metastatic Breast Cancer
Metastatic Breast Cancer · Recurrent Breast Cancer · Stage IV Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00369655 ↗Enrolled (actual)
21
Serious AEs
47.6%
Results posted
May 2014
Primary outcome: Primary: Proportion of Patients With Confirmed Tumor Response — 1; 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ziv-aflibercept (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With Confirmed Tumor Response |
1; 20 | — |
| PRIMARY Proportion of Patients Receiving Vascular Endothelial Growth Factor (VEGF) Trap With 6-month Progression-free Survival |
2 | — |
| SECONDARY Progression Free Survival |
2.7 | — |
| SECONDARY Overall Survival |
12.7 | — |
| SECONDARY Median Duration of Response |
4.6 | — |
| SECONDARY Number of Participant With Previous Treatment of Anti-HER2 With Cardiac Events |
1 | — |
Summary
This phase II trial is studying how well VEGF Trap works in treating patients with metastatic breast cancer. VEGF Trap may stop the growth of tumor cells by blocking blood flow to the tumor
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed adenocarcinoma of the breast
- Clinical evidence of metastatic disease
- No more than 2 prior chemotherapy regimens for metastatic disease
- Prior neoadjuvant or adjuvant chemotherapy allowed*
- At least 1 prior regimen (in any setting) must have included a taxane and/or an anthracycline
- Measurable disease, defined as ≥ 1 lesion whose longest diameter can be accurately measured per RECIST criteria
- No nonmeasurable disease, defined as all other lesions, including small lesions(longest diameter 3 months
- WBC ≥ 3,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 75,000/mm³
- Hemoglobin > 8.0 g/dL
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 3 times ULN
- AST and ALT ≤ 2.5 times ULN
- Creatinine ≤ 1.5 times ULN
- Urine protein: creatinine ratio 150/100 mm Hg OR systolic BP > 180 mm Hg if diastolic blood pressure 1.5 allowed provided the following criteria are met:
- INR in-range (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
- No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No concurrent participation in another investigational clinical trial
- No other concurrent chemotherapeutic agents, endocrine therapy, biologic agents, radiotherapy, or other nonprotocol antitumor therapy
Data sourced from ClinicalTrials.gov (NCT00369655). 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.