Phase 2
N=33
Phase II NCT (Neoadjuvant Chemotherapy) w/ Weekly Abraxane in Combination With Carboplatin & Bevacizumab in Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00675259 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Number of Patients With Pathologic Complete Response (pCR) — 6 patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bevacizumab (Drug); carboplatin (Drug); nab-paclitaxel (Drug); Surgery (Procedure); Adjuvant chemotherapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Pathologic Complete Response (pCR) |
6 | — |
| PRIMARY Side Effects of Weekly Nab-paclitaxel, Carboplatin and Bevacizumab |
1; 2; 1 | — |
| SECONDARY Evaluation of Dynamic Contrast-enhanced Magnetic Resonance Imaging in Assessing pCR at Baseline and After 2 Cycles of Neoadjuvant Therapy |
0.65; .4 | — |
| SECONDARY Overall Expression of LZTS1 Before and After Neoadjuvant Therapy as Assessed by Immunohistochemistry |
2; 2; 6; 0; 0; 2 | — |
Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and carboplatin, 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 find tumor cells and help kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying the side effects and how well giving paclitaxel albumin-stabilized nanoparticle formulation and carboplatin together with bevacizumab works in treating women undergoing surgery for stage II or stage III breast cancer.
Eligibility Criteria
Inclusion:
- Histologically confirmed breast cancer
- Clinically or radiographically measurable residual tumor after core biopsy
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Age ≥18 yrs
- Absolute neutrophil count ≥ 1,500/mm³
- Hemoglobin ≥ 9 g/dL
- Platelet count ≥ 100,000/ mm³
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Urine protein: creatinine ratio 150 mm Hg and/or diastolic BP > 100 mm Hg despite antihypertensive medications
- History of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association class II-IV congestive heart failure
- History of stroke or transient ischemic attack at any time
- Significant vascular disease (e.g., aortic aneurysm or aortic dissection)
- No symptomatic peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy
- Significant traumatic injury within the past 28 days
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- Serious, non-healing wound, ulcer, or bone fracture
- Known hypersensitivity to any component of bevacizumab
Data sourced from ClinicalTrials.gov (NCT00675259). 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.