Phase 2
Completed N=59
Nab-Paclitaxel and Bevacizumab Followed By Bevacizumab and Erlotinib in Metastatic Breast Cancer
Estrogen Receptor-negative Breast Cancer · HER2-negative Breast Cancer · Progesterone Receptor-negative Breast Cancer · Recurrent Breast Cancer
Source: ClinicalTrials.gov NCT00733408 ↗
Enrolled (actual)
59
Serious AEs
9.1%
Results posted
Dec 2018
Primary outcomePrimary: Progression-free Survival (PFS) — 9.1 Months
Summary
This phase II trial studies how well giving paclitaxel albumin-stabilized nanoparticle (Nab-paclitaxel) formulation together with bevacizumab followed by bevacizumab and erlotinib hydrochloride work in treating patients with metastatic breast cancer. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, 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 prevent cancer growth by blocking the ability of cancer cells to grow and spread. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This trial evaluates a maintenance treatment with erlotinib and bevacizumab after Nab-paclitaxel and bevacizumab which may control cancer growth with biologic therapies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) |
9.1 | — |
| SECONDARY Overall Survival |
18.1 | — |
| SECONDARY Percentage of Participants With Response |
74; 19 | — |
| SECONDARY Incidence of Adverse Events as Assessed by National Cancer Institute CTCAE Version 3.0 |
34; 14 | — |
| SECONDARY EGFR and SPARC Expression in the Primary Tumor |
— | — |
| SECONDARY Changes in Levels of Circulating Tumor Cells |
0.857; 0.531 | — |
| SECONDARY Changes in Levels of Circulating Endothelial Cells |
1.458; 1.332 | — |
Eligibility Criteria
Inclusion Criteria
- Have histologically confirmed invasive breast cancer that is estrogen receptor (ER) negative (= 100,000 cells/mm^3
- Hemoglobin > 9.0 g/dL
- Absolute neutrophil count (ANC) >= 1, 500 cells/mm^3
- Creatinine = 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)
- Any prior history of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association (NYHA) grade II or greater congestive heart failure
- History of myocardial infarction or unstable angina within 6 months prior to study enrollment
- History of stroke or transient ischemic attack within 6 months prior to study enrollment
- Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
- Symptomatic peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
- Serious, non-healing wound, ulcer, or bone fracture
- Proteinuria at screening as demonstrated by either:
- Urine protein: creatinine (UPC) ratio >= 1.0 at screening OR
- Urine dipstick for proteinuria > 2+ (patients discovered to have > 2+ proteinuria on dipstick urinalysis at baseline must have a UPC ratio done that is = 1.0 then the patient should undergo a 24-hour urine collection which must demonstrate =< 1 g of protein in 24 hours for the patient to be eligible)
- Known hypersensitivity to any component of bevacizumab or to nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation)
Data sourced from ClinicalTrials.gov (NCT00733408). 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.